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A Comparison of Ketofol (Ketamine and Propofol Admixture) Versus Propofol as Induction Agents on Hemodynamic Parameters

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ClinicalTrials.gov Identifier: NCT01065350
Recruitment Status : Completed
First Posted : February 9, 2010
Results First Posted : May 3, 2013
Last Update Posted : May 3, 2013
Sponsor:
Collaborator:
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
Nathan J. Smischney, Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Blood Pressure
Interventions Drug: Propofol
Drug: Ketamine
Enrollment 85
Recruitment Details Patients requiring surgical procedures with general anesthesia were recruited and enrolled at Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire from December 2010 to March 2011.
Pre-assignment Details  
Arm/Group Title Propofol Ketofol
Hide Arm/Group Description As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL. As part of the induction, patients will be given 20 mL syringe of an admixture called "ketofol," which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose.
Period Title: Overall Study
Started 43 42
Completed 43 41
Not Completed 0 1
Reason Not Completed
Received incorrect drug allocation             0             1
Arm/Group Title Propofol Ketofol Total
Hide Arm/Group Description As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL. As part of the induction, patients will be given 20 mL syringe of an admixture called "ketofol," which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose. One subject in the ketofol group was excluded from analysis due to incorrect study drug assignment and outside the protocol-specified dose. Total of all reporting groups
Overall Number of Baseline Participants 43 41 84
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 41 participants 84 participants
43  (11) 42  (12) 42.68  (11.51)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 41 participants 84 participants
Female
28
  65.1%
27
  65.9%
55
  65.5%
Male
15
  34.9%
14
  34.1%
29
  34.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 43 participants 41 participants 84 participants
43 41 84
Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 43 participants 41 participants 84 participants
69.2  (11.7) 68.9  (11.2) 68.97  (11.41)
Body Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 43 participants 41 participants 84 participants
169.9  (9.1) 168.9  (9.2) 169.40  (9.03)
Systolic Blood Pressure   [1] 
Mean (Standard Deviation)
Unit of measure:  Millimeters of mercury (mm Hg)
Number Analyzed 43 participants 41 participants 84 participants
125  (17) 122  (15) 124.19  (16.41)
[1]
Measure Description: Mean pre-operative systolic blood pressure
Diastolic Blood Pressure   [1] 
Mean (Standard Deviation)
Unit of measure:  Millimeters of mercury (mm Hg)
Number Analyzed 43 participants 41 participants 84 participants
76  (12) 76  (10) 76  (11)
[1]
Measure Description: Mean pre-operative diastolic blood pressure
Heart Rate   [1] 
Mean (Standard Deviation)
Unit of measure:  Beats per minute
Number Analyzed 43 participants 41 participants 84 participants
72  (16) 73  (14) 73  (15)
[1]
Measure Description: Mean pre-operative heart rate
American Society of Anesthesiology (ASA) Physical Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 43 participants 41 participants 84 participants
ASA Status 1 21 14 35
ASA Status 2 22 27 49
[1]
Measure Description:

ASA Physical Status 1 - A normal healthy patient

ASA Physical Status 2 - A patient with mild systemic disease

1.Primary Outcome
Title Percent of Subjects With a Greater Than 20% Decrease in Systolic Blood Pressure (SBP) Following Induction of General Anesthesia
Hide Description Blood pressure was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The percentage of subjects experiencing decreases in SBP of greater than 20% during the specified time intervals is reported, as compared to the baseline systolic blood pressure reading. There are two numbers in a blood pressure reading, and they are expressed in millimeters of mercury (mm Hg). This tells how high in millimeters the pressure of your blood raises a column of mercury. The numbers usually are expressed in the form of a fraction; an example of a blood pressure reading is 120/80 mm Hg. The first, or top, number (120 in the example) is the systolic pressure. The systolic pressure is the measure of your blood pressure as the heart contracts and pumps blood.
Time Frame Baseline, 5 minutes, 10 minutes, 30 minutes post induction
Hide Outcome Measure Data
Hide Analysis Population Description
85 patients were enrolled (43 Propofol/42 Ketofol). However, one subject randomized to the ketofol group received the wrong study drug and in a larger dose than indicated in protocol. This subject was excluded from the analysis and baseline measures.
Arm/Group Title Propofol Ketofol
Hide Arm/Group Description:
As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
As part of the induction, patients will be given 20 mL syringe of an admixture called "ketofol," which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose.
Overall Number of Participants Analyzed 43 41
Measure Type: Number
Unit of Measure: Percentage of subjects
SBP baseline to 5 minutes 48 12
SBP baseline to 10 minutes 67 39
SBP baseline to 30 minutes 76 68
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Propofol, Ketofol
Comments Systolic Blood Pressure (SBP) from baseline to 5 minutes post induction was compared between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments A p value of < 0.05 was considered to indicate statistical significance.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 6.87
Confidence Interval (2-Sided) 95%
2.07 to 26.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Propofol, Ketofol
Comments Systolic Blood Pressure (SBP) from baseline to 10 minutes post induction was compared between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments A p value of < 0.05 was considered to indicate statistical significance.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.24
Confidence Interval (2-Sided) 95%
1.21 to 8.75
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Propofol, Ketofol
Comments Systolic Blood Pressure (SBP) from baseline to 30 minutes post induction was compared between treatment groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments A p value of < 0.005 was considered to indicate statistical significance.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.53
Confidence Interval (2-Sided) 95%
0.52 to 4.55
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percent of Subjects With a Greater Than 20% Decrease in Diastolic Blood Pressure (DBP) Following Induction of General Anesthesia
Hide Description Blood pressure was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The percentage of subjects experiencing decreases in DBP of greater than 20% during the specified time intervals is reported, as compared to the baseline DBP reading. The second or lower number of a blood pressure reading is the DBP and is the measure taken when your heart is at rest.
Time Frame Baseline, 5 minutes, 10 minutes, 30 minutes post induction
Hide Outcome Measure Data
Hide Analysis Population Description
85 patients were enrolled (43 Propofol/42 Ketofol). However, one subject randomized to the ketofol group received the wrong study drug and in a larger dose than indicated in protocol. This subject was excluded from the analysis and baseline measures.
Arm/Group Title Propofol Ketofol
Hide Arm/Group Description:
As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
As part of the induction, patients will be given 20 mL syringe of an admixture called "ketofol," which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose.
Overall Number of Participants Analyzed 43 41
Measure Type: Number
Unit of Measure: Percentage of subjects
DBP baseline to 5 minutes 48 17
DBP baseline to 10 minutes 62 41
DBP baseline to 30 minutes 90 78
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Propofol, Ketofol
Comments Diastolic Blood Pressure (DBP) from baseline to 5 minutes post induction was compared between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments A p value of < 0.05 was considered to indicate statistical significance.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.64
Confidence Interval (2-Sided) 95%
1.54 to 14.92
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Propofol, Ketofol
Comments Diastolic Blood Pressure (DBP) from baseline to 10 minutes post induction was compared between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments A p value of < 0.05 was considered to indicate statistical significance.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.38
Confidence Interval (2-Sided) 95%
0.91 to 6.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Propofol, Ketofol
Comments Diastolic Blood Pressure (DBP) from baseline to 30 minutes post induction was compared between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments A p value of < 0.05 was considered to indicate statistical significance.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.74
Confidence Interval (2-Sided) 95%
0.68 to 13.19
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percent of Subjects With a Greater Than 20% Decrease in Mean Arterial Pressure (MAP) Following Induction of General Anesthesia
Hide Description MAP was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The percentage of subjects experiencing decreases in MAP of greater than 20% during the specified time intervals is reported, as compared to the baseline MAP reading.
Time Frame Baseline, 5 minutes, 10 minutes, 30 minutes post induction
Hide Outcome Measure Data
Hide Analysis Population Description
85 patients were enrolled (43 Propofol/42 Ketofol). However, one subject randomized to the ketofol group received the wrong study drug and in a larger dose than indicated in protocol. This subject was excluded from the analysis and baseline measures.
Arm/Group Title Propofol Ketofol
Hide Arm/Group Description:
As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
As part of the induction, patients will be given 20 mL syringe of an admixture called "ketofol," which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose.
Overall Number of Participants Analyzed 43 41
Measure Type: Number
Unit of Measure: Percentage of subjects
MAP baseline to 5 minutes 44 10
MAP baseline to 10 minutes 60 35
MAP baseline to 30 minutes 83 75
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Propofol, Ketofol
Comments Mean Arterial Pressure (MAP) from baseline to 5 minutes post induction was compared between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments A p value of < 0.05 was considered to indicate statistical significance.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 7.12
Confidence Interval (2-Sided) 95%
1.98 to 31.64
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Propofol, Ketofol
Comments Mean Arterial Pressure (MAP) from baseline to 10 minutes post induction was compared between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments A p value of < 0.05 was considered to indicate statistical significance.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.84
Confidence Interval (2-Sided) 95%
1.07 to 7.65
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Propofol, Ketofol
Comments Mean Arterial Pressure (MAP) from baseline to 30 minutes post induction was compared between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.33
Comments A p value of < 0.05 was considered to indicate statistical significance.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.71
Confidence Interval (2-Sided) 95%
0.51 to 5.97
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Average Change in Cardiac Output (CO)
Hide Description

CO was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in CO as compared to baseline CO during the specified time intervals is reported.

CO is defined as the quantity of blood ejected per minute by the heart into the systemic circulation. It is the product of the heart rate (HR) (beats per minute) times the stroke volume (SV) (milliliters of blood ejected during each contraction).

Time Frame Baseline, 5 minutes, 10 minutes post induction
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population of 41/40 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.
Arm/Group Title Propofol Ketofol
Hide Arm/Group Description:
As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
As part of the induction, patients will be given 20 mL syringe of an admixture called "ketofol," which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose.
Overall Number of Participants Analyzed 41 40
Mean (Standard Deviation)
Unit of Measure: Liters per minute
5 minutes post induction -0.8  (0.8) -0.6  (0.6)
10 minutes post induction -1.0  (1.0) -0.9  (0.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Propofol, Ketofol
Comments Average change in Cardiac Output (CO) from baseline to 5 minutes post induction was compared between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.1 to 0.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Propofol, Ketofol
Comments Average change in Cardiac Output (CO) from baseline to 10 minutes post induction was compared between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.3 to 0.5
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Average Change in Cardiac Index (CI)
Hide Description

CI was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in CI as compared to the baseline CI during the specified time intervals is reported.

To determine CI, cardiac output is divided by the body surface area in order to account for body size.

Time Frame Baseline, 5 minutes, 10 minutes post induction
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population of 41/40 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.
Arm/Group Title Propofol Ketofol
Hide Arm/Group Description:
As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
As part of the induction, patients will be given 20 mL syringe of an admixture called "ketofol," which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose.
Overall Number of Participants Analyzed 41 40
Mean (Standard Deviation)
Unit of Measure: Liters per minute per m^2 of body area
5 minutes post induction -0.4  (0.4) -0.3  (0.4)
10 minutes post induction -0.6  (0.6) -0.5  (0.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Propofol, Ketofol
Comments Average change in Cardiac Index (CI) from baseline to 5 minutes post induction was compared between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.1 to 0.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Propofol, Ketofol
Comments Average change in Cardiac Index (CI) from baseline to 10 minutes post induction was compared between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.71
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.2 to 0.3
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Average Change in Heart Rate (HR)
Hide Description HR was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in HR (as compared to baseline HR) during the specified time intervals is reported.
Time Frame Baseline, 5 minutes, 10 minutes post induction
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Propofol Ketofol
Hide Arm/Group Description:
As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
As part of the induction, patients will be given 20 mL syringe of an admixture called "ketofol," which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose.
Overall Number of Participants Analyzed 43 41
Mean (Standard Deviation)
Unit of Measure: Beats per minute
5 minutes post induction -4.0  (4.5) -4.6  (6.0)
10 minutes post induction -5.2  (5.2) -7.0  (8.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Propofol, Ketofol
Comments Average heart rate from baseline to 5 minutes post induction was compared between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.61
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-2.9 to 1.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Propofol, Ketofol
Comments Average heart rate from baseline to 10 minutes post induction was compared between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.8
Confidence Interval (2-Sided) 95%
-4.8 to 1.1
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Average Change in Systolic Blood Pressure (SBP)
Hide Description Blood pressure was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in SBP (as compared to baseline SBP) during the specified time intervals is reported.
Time Frame Baseline, 5 minutes, 10 minutes post induction
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Propofol Ketofol
Hide Arm/Group Description:
As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
As part of the induction, patients will be given 20 mL syringe of an admixture called "ketofol," which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose.
Overall Number of Participants Analyzed 43 41
Mean (Standard Deviation)
Unit of Measure: mmHg
5 minutes post induction -26.3  (16.2) -12.5  (12.4)
10 minutes post induction -30.6  (16.6) -21.8  (16.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Propofol, Ketofol
Comments Average change in Systolic Blood Pressure from baseline to 5 minutes post induction was compared between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 13.7
Confidence Interval (2-Sided) 95%
7.5 to 20.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Propofol, Ketofol
Comments Average change in Systolic Blood Pressure from baseline to 10 minutes post induction was compared between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 8.8
Confidence Interval (2-Sided) 95%
0.2 to 9.5
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Average Change in Diastolic Blood Pressure (DBP)
Hide Description Blood pressure was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in DBP (as compared to baseline DBP) during the specified time intervals is reported.
Time Frame Baseline, 5 minutes, 10 minutes post induction
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Propofol Ketofol
Hide Arm/Group Description:
As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
As part of the induction, patients will be given 20 mL syringe of an admixture called "ketofol," which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose.
Overall Number of Participants Analyzed 43 41
Mean (Standard Deviation)
Unit of Measure: mmHg
5 minutes post induction -15.9  (11.3) -8.8  (9.1)
10 minutes post induction -19.3  (11.5) -14.5  (9.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Propofol, Ketofol
Comments Average change in Diastolic Blood Pressure from baseline to 5 minutes post induction was compared between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.1
Confidence Interval (2-Sided) 95%
2.7 to 11.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Propofol, Ketofol
Comments Average change in Diastolic Blood Pressure from baseline to 10 minutes post induction was compared between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.042
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.8
Confidence Interval (2-Sided) 95%
0.2 to 9.5
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Average Change in Mean Arterial Pressure (MAP)
Hide Description

MAP was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in MAP from baseline during the specified time intervals is reported.

MAP is a term used in medicine to describe an average blood pressure in an individual. It is defined as the average arterial pressure during a single cardiac cycle.

Time Frame Baseline, 5 minutes, 10 minutes post induction
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population of 43/40 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.
Arm/Group Title Propofol Ketofol
Hide Arm/Group Description:
As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
As part of the induction, patients will be given 20 mL syringe of an admixture called "ketofol," which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose.
Overall Number of Participants Analyzed 43 40
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury (mmHg)
5 minutes post induction -18.7  (11.5) -9.3  (9.4)
10 minutes post induction -22.6  (11.7) -16.2  (11.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Propofol, Ketofol
Comments Average change in Mean Arterial Pressure (MAP) from baseline to 5 minutes post induction was compared between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 9.4
Confidence Interval (2-Sided) 95%
4.8 to 13.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Propofol, Ketofol
Comments Average change in Mean Arterial Pressure from baseline to 10 minutes post induction was compared between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.3
Confidence Interval (2-Sided) 95%
1.4 to 11.3
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Average Change in Total Peripheral Resistance (TPR)
Hide Description TPR was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in TPR from baseline during the specified time intervals is reported. TPR is the overall resistance to blood flow through the systemic blood vessels.
Time Frame Baseline, 5 minutes, 10 minutes post induction
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population of 39/38 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.
Arm/Group Title Propofol Ketofol
Hide Arm/Group Description:
As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
As part of the induction, patients will be given 20 mL syringe of an admixture called "ketofol," which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose.
Overall Number of Participants Analyzed 39 38
Mean (Standard Deviation)
Unit of Measure: dynes * sec/cm^-5
5 minutes post induction -261.2  (211.9) -147.6  (161.8)
10 minutes post induction -321.7  (251.3) -235.0  (226.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Propofol, Ketofol
Comments Average change in Total Peripheral Resistance (TPR) from baseline to 5 minutes post induction was compared between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 113.6
Confidence Interval (2-Sided) 95%
28.1 to 199.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Propofol, Ketofol
Comments Average change in Total Peripheral Resistance (TPR) from baseline to 10 minutes post induction was compared between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 86.8
Confidence Interval (2-Sided) 95%
-21.7 to 195.3
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Average Change in Total Peripheral Resistance Index (TPRI)
Hide Description TPRI was recorded every minute for a total of 30 minutes after anesthesia was induced and results were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in TPRI from baseline during the specified time intervals is reported.
Time Frame Baseline, 5 minutes, 10 minutes post induction
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population of 39/39 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.
Arm/Group Title Propofol Ketofol
Hide Arm/Group Description:
As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
As part of the induction, patients will be given 20 mL syringe of an admixture called "ketofol," which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose.
Overall Number of Participants Analyzed 39 39
Mean (Standard Deviation)
Unit of Measure: dynes * sec/cm^-5/m^2
5 minutes post induction -457.6  (362.4) -275.0  (293.2)
10 minutes post induction -559.3  (421.0) -430.6  (407.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Propofol
Comments Average change in Total Peripheral Resistance Index (TPRI) from baseline to 5 minutes post induction was compared between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 182.6
Confidence Interval (2-Sided) 95%
33.8 to 331.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Propofol, Ketofol
Comments Average change in Total Peripheral Resistance Index (TPRI) from baseline to 10 minutes post induction was compared between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 128.7
Confidence Interval (2-Sided) 95%
-58.1 to 315.5
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Average Change in Stroke Volume (SV)
Hide Description SV was recorded every minute for a total of 30 minutes after anesthesia was induced and results were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in SV from baseline during the specified time intervals is reported. SV is the milliliters of blood ejected during each contraction of the heart.
Time Frame Baseline, 5 minutes, 10 minutes post induction
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population of 41/40 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.
Arm/Group Title Propofol Ketofol
Hide Arm/Group Description:
As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
As part of the induction, patients will be given 20 mL syringe of an admixture called "ketofol," which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose.
Overall Number of Participants Analyzed 41 40
Mean (Standard Deviation)
Unit of Measure: Milliliters of blood per beat
5 minutes post induction -12.2  (10) -7.8  (7.8)
10 minutes post induction -16.4  (12.8) -11.6  (8.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Propofol, Ketofol
Comments Average change in Stroke Volume (SV) from baseline to 5 minutes post induction was compared between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.029
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.4
Confidence Interval (2-Sided) 95%
0.5 to 8.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Propofol, Ketofol
Comments Average change in Cardiac Index (CI) from baseline to 10 minutes post induction was compared between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.051
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.8
Confidence Interval (2-Sided) 95%
-0.0 to 9.7
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Average Change in Stroke Volume Index (SVI)
Hide Description SVI was recorded every minute for a total of 30 minutes after anesthesia was induced and results were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in SVI (as compared to baseline SVI) during the specified time intervals is reported. To determine SVI, stroke volume is divided by the body surface area in order to account for body size.
Time Frame Baseline, 5 minutes, 10 minutes post induction
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population of 41/40 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.
Arm/Group Title Propofol Ketofol
Hide Arm/Group Description:
As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
As part of the induction, patients will be given 20 mL syringe of an admixture called "ketofol," which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose.
Overall Number of Participants Analyzed 41 40
Mean (Standard Deviation)
Unit of Measure: Milliters per beat per m^2 of body area
5 minutes post induction -6.8  (5.6) -4.3  (4.3)
10 minutes post induction -9.2  (6.8) -6.6  (4.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Propofol, Ketofol
Comments Average change in Stroke Volume Index (SVI) from baseline to 5 minutes post induction was compared between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.027
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.5
Confidence Interval (2-Sided) 95%
0.3 to 4.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Propofol, Ketofol
Comments Average change in Stroke Volume Index (SVI) from baseline to 10 minutes post induction was compared between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.052
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.6
Confidence Interval (2-Sided) 95%
-0.0 to 5.2
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Average Change in Stroke Volume Variation (SVV)
Hide Description SVV was recorded every minute for a total of 30 minutes after anesthesia was induced and results were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. SVV is a dynamic flow-based parameter and together with cardiac output provides an indication of fluid responsiveness. The average change in SVV (as compared to baseline SVV) during the specified time intervals is reported. SVV is calculated by taking the SVmax - SVmin /*100/ SV mean.
Time Frame Baseline, 5 minutes, 10 minutes post induction
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population of 38/35 (vs. 43/41 at baseline) is due to the NICOM not functioning properly during certain aspects of the procedure and therefore, did not provide a number.
Arm/Group Title Propofol Ketofol
Hide Arm/Group Description:
As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
As part of the induction, patients will be given 20 mL syringe of an admixture called "ketofol," which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose.
Overall Number of Participants Analyzed 38 35
Mean (Standard Deviation)
Unit of Measure: Percentage of mean stroke volume
5 minutes post induction -2.2  (2.0) -2.6  (2.2)
10 minutes post induction -2.6  (2.1) -3.1  (2.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Propofol, Ketofol
Comments Average change in Stroke Volume Variation (SVV) from baseline to 5 minutes post induction was compared between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-1.4 to 0.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Propofol, Ketofol
Comments Average change in Stroke Volume Variation (SVV) from baseline to 10 minutes post induction was compared between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.37
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-1.6 to 0.6
Estimation Comments [Not Specified]
Time Frame Baseline to 30 minutes post induction of anesthesia
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Propofol Ketofol
Hide Arm/Group Description As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL. As part of the induction, patients will be given 20 mL syringe of an admixture called "ketofol," which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose.
All-Cause Mortality
Propofol Ketofol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Propofol Ketofol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/42 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Propofol Ketofol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/42 (0.00%) 
The dose ratio implemented was not ideal. Enrollment was limited to ASA I and II patients only.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nathan J. Smischney, MD
Organization: Mayo Clinic
Phone: 507-255-6032
EMail: smischney.nathan@mayo.edu
Layout table for additonal information
Responsible Party: Nathan J. Smischney, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01065350    
Other Study ID Numbers: 22063
First Submitted: February 7, 2010
First Posted: February 9, 2010
Results First Submitted: February 15, 2013
Results First Posted: May 3, 2013
Last Update Posted: May 3, 2013