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A Comparison of Remifentanil and Dexmedetomidine for Craniotomy Perioperative Hemodynamics and Postoperative Pain (RemivsDex)

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ClinicalTrials.gov Identifier: NCT01269918
Recruitment Status : Completed
First Posted : January 4, 2011
Results First Posted : December 20, 2016
Last Update Posted : December 20, 2016
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Adult Intracranial Tumor
Adult Solid Tumor
Interventions Drug: Remifentanil
Drug: Dexmedetomidine
Enrollment 142
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Remifentanil Dexmedetomidine
Hide Arm/Group Description

Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Period Title: Overall Study
Started 71 71
Completed 71 68
Not Completed 0 3
Reason Not Completed
Did not receive study drug             0             3
Arm/Group Title Remifentanil Dexmedetomidine Total
Hide Arm/Group Description

Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Total of all reporting groups
Overall Number of Baseline Participants 71 68 139
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 71 participants 68 participants 139 participants
55  (14) 56  (14) 56  (14)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 68 participants 139 participants
Female
37
  52.1%
33
  48.5%
70
  50.4%
Male
34
  47.9%
35
  51.5%
69
  49.6%
1.Primary Outcome
Title Hemodynamics
Hide Description Hemodynamics were defined as mean arterial pressure (MAP), measured in milimeters of mercury (mmHg). This outcome was analyzed using a repeated measures ANOVA approach. In the outcome measure data table, mean ± standard deviation MAP was reported as the aggregate mean across time points.
Time Frame 15, 30, 45, 60, and 90 minutes after extubation.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Remifentanil Dexmedetomidine
Hide Arm/Group Description:

Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Overall Number of Participants Analyzed 71 68
Mean (Standard Deviation)
Unit of Measure: mmHg
98  (11) 88  (12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remifentanil, Dexmedetomidine
Comments Dexmedetomidine versus remifentanyl on MAP collapsed over time was estimated using a 1-tailed t test from a repeated measures ANOVA model.
Type of Statistical Test Non-Inferiority or Equivalence
Comments We used a noninferiority delta of 7.5 mmHg. If noninferiority was detected, we proceeded to test for superiority.
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9
Confidence Interval (2-Sided) 95%
-13 to -5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Remifentanil, Dexmedetomidine
Comments Dexmedetomidine versus remifentanyl on MAP collapsed over time was estimated using a 1-tailed t test from a repeated measures ANOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9
Confidence Interval (2-Sided) 97.5%
-13 to -4
Estimation Comments [Not Specified]
2.Primary Outcome
Title Postoperative Pain
Hide Description Pain was measured using the visual analogue scale (VAS), where 0 is defined as no pain and 10 is defined as worst pain imaginable. This outcome was analyzed using a repeated measures ANOVA approach. In the outcome measure data table, mean ± standard deviation pain was reported as the aggregate mean across time points.
Time Frame 15, 30, 45, 60, and 90 minutes after extubation.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Remifentanil Dexmedetomidine
Hide Arm/Group Description:

Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Overall Number of Participants Analyzed 71 68
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.1  (2.4) 2.9  (2.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remifentanil, Dexmedetomidine
Comments Dexmedetomidine versus remifentanyl on VAS pain score estimated from a 1-tailed t test from a repeated measures ANOVA model.
Type of Statistical Test Non-Inferiority or Equivalence
Comments We used a noninferiority delta of 1 point. If noninferiority was detected, we proceeded to test for superiority.
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.9
Confidence Interval (2-Sided) 95%
-2.7 to -1.1
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Remifentanil, Dexmedetomidine
Comments Dexmedetomidine versus remifentanyl on VAS pain score estimated from a 1-tailed t test from a repeated measures ANOVA model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.9
Confidence Interval (2-Sided) 97.5%
-2.8 to -0.9
Estimation Comments [Not Specified]
3.Primary Outcome
Title Total Opioid Consumption
Hide Description Total opioid consumption was defined as the sum of all opioid doses given within the first 90 minutes after surgery, converted to milligram morphine equivalents.
Time Frame Initial 90 minutes of recover after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Remifentanil Dexmedetomidine
Hide Arm/Group Description:

Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Overall Number of Participants Analyzed 71 68
Median (Inter-Quartile Range)
Unit of Measure: mg morphine equivalents
10
(7 to 15)
5
(0 to 10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remifentanil, Dexmedetomidine
Comments Dexmedetomidine versus remifentanyl on opioid consumption estimated from a Wilcoxon rank sum test
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority delta = 2 mg opioid
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -5
Confidence Interval (2-Sided) 95%
-10 to -5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Remifentanil, Dexmedetomidine
Comments Dexmedetomidine versus remifentanyl on opioid consumption estimated from a Wilcoxon rank sum test
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -5
Confidence Interval (2-Sided) 97.5%
-10 to -3
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Heart Rate
Hide Description Heart rate was determined from the arterial catheter and measured as beats per minute. This outcome was analyzed using a repeated measures ANOVA approach.
Time Frame 15, 30, 45, 60, and 90 minutes after extubation.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Remifentanil Dexmedetomidine
Hide Arm/Group Description:

Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Overall Number of Participants Analyzed 71 68
Mean (Standard Deviation)
Unit of Measure: beats per minute
Heart rate 15 minutes after extubation 76  (15) 68  (13)
Heart rate 30 minutes after extubation 72  (14) 67  (13)
Heart rate 45 minutes after extubation 73  (14) 66  (13)
Heart rate 60 minutes after extubation 73  (13) 66  (12)
Heart rate 90 minutes after extubation 75  (13) 69  (14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remifentanil, Dexmedetomidine
Comments Dexmedetomidine versus remifentanyl on heart rate was assessed using a linear mixed effects model adjusting for baseline heart rate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6
Confidence Interval (2-Sided) 95%
-10 to 3
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Modified Short Orientation Memory Concentration Test (SOMCT)
Hide Description The Modified Short Orientation Memory Concentration Test (SOMCT) is a validated questionnaire that discriminates among mild, moderate, and severe cognitive deficits. SOMCT is based on 6 questions and produces a total score ranging from 0 (worst possible function) to 28 (best possible function). Scores > 20 are considered normal. This outcome was analyzed using a repeated measures ANOVA approach.
Time Frame 15, 30, 45, 60, and 90 minutes after extubation.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Remifentanil Dexmedetomidine
Hide Arm/Group Description:

Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Overall Number of Participants Analyzed 71 68
Mean (Standard Deviation)
Unit of Measure: units on a scale
SOMCT 15 minutes after extubation 22  (9) 18  (11)
SOMCT 30 minutes after extubation 25  (7) 20  (11)
SOMCT 45 minutes after extubation 25  (6) 23  (9)
SOMCT 60 minutes after extubation 26  (5) 24  (7)
SOMCT 90 minutes after extubation 26  (5) 25  (7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remifentanil, Dexmedetomidine
Comments Dexmedetomidine versus remifentanyl on SOMCT estimated using a linear mixed effects model adjusting for baseline SOMCT score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-2.6 to 0.5
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Aldrete Score
Hide Description The Aldrete score measured level of sedation and fitness and is used to assess the appropriate departure time from the post anesthesia care unit. The score ranges from 0 to 10, where 0 indicates poor fitness (and such patients are transferred to the ICU), while 10 indicates good fitness. This outcome was analyzed using a repeated measures ANOVA approach.
Time Frame 15, 30, 45, 60, and 90 minutes after extubation.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Remifentanil Dexmedetomidine
Hide Arm/Group Description:

Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Overall Number of Participants Analyzed 71 68
Mean (Standard Deviation)
Unit of Measure: units on a scale
Aldrete score at 15 minutes after extubation 8.4  (1) 8  (1.4)
Aldrete score at 30 minutes after extubation 8.7  (1) 8.3  (1.4)
Aldrete score at 45 minutes after extubation 9.0  (1.0) 8.7  (1.1)
Aldrete score at 60 minutes after extubation 9.2  (0.9) 8.9  (1.1)
Aldrete score at 90 minutes after extubation 9.4  (0.8) 9.1  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remifentanil, Dexmedetomidine
Comments Dexmedetomidine versus remifentanyl on Aldrete score estimated using a linear mixed effects model adjusting for baseline Aldrete score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.6 to 0.03
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Nursing Workload Comparison
Hide Description To evaluate the nurses workload when either of the two drugs are given in terms Nursing Research Usage form's therapeutic index scoring system. This score ranges from 0 (minimal interventions and time spent by nurses on study patient) to 22 (maximum interventions and time spent by nurses on the study patient).
Time Frame 90 minutes after extubation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Remifentanil Dexmedetomidine
Hide Arm/Group Description:

Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Overall Number of Participants Analyzed 71 68
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
6
(6 to 8)
5.5
(5 to 7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remifentanil, Dexmedetomidine
Comments Dexmedetomidine versus remifentanyl on Nursing workload comparison estimated using a Wilcoxon rank sum test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -1
Confidence Interval (2-Sided) 95%
-1 to -0.001
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Drug Stop Time to Open Eyes
Hide Description time until patient first opened their eyes, squeezed a hand, or wiggled their toes in response to verbal commands after surgery
Time Frame Anesthesia drug stop time to open eyes. Time is measured continuously until patients eyes open, regardless of how long it takes.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Remifentanil Dexmedetomidine
Hide Arm/Group Description:

Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Overall Number of Participants Analyzed 71 68
Median (Inter-Quartile Range)
Unit of Measure: minutes
8
(7 to 9)
38
(29 to 44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remifentanil, Dexmedetomidine
Comments Remifentanyl versus Dexmedetomidine on time to open eyes estimated using Cox regression.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.11
Confidence Interval (2-Sided) 95%
0.07 to 0.18
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Drug Stop Time to Recall
Hide Description Time between extubation until patients could say their names.
Time Frame Time between extubation until patients could say their names.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Remifentanil Dexmedetomidine
Hide Arm/Group Description:

Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Overall Number of Participants Analyzed 71 68
Median (Inter-Quartile Range)
Unit of Measure: minutes
13
(10 to 15)
42
(36 to 49)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remifentanil, Dexmedetomidine
Comments Remifentanyl versus dexmedetomidine on time to recall assessed using Cox regression.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
0.07 to 0.19
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Drug Stop Time to Fitness to Discharge
Hide Description [Not Specified]
Time Frame Anesthesia drug stop time to fitness to discharge. Time is measured continuously until fitness for discharge is reached, regardless of how long it takes.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Remifentanil Dexmedetomidine
Hide Arm/Group Description:

Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Overall Number of Participants Analyzed 71 68
Median (Inter-Quartile Range)
Unit of Measure: minutes
150
(117 to 175)
172
(160 to 206)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remifentanil, Dexmedetomidine
Comments Remifentanyl versus Dexmedetomidine on time to fitness discharge estimated using Cox regression.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.68
Confidence Interval (2-Sided) 95%
0.48 to 0.95
Estimation Comments [Not Specified]
11.Secondary Outcome
Title End Case to Post Anesthesia Care Unit (PACU) Discharge
Hide Description Post Anesthesia Care Unit (PACU) Discharge time is the timing at which patients are discharged from the PACU. This outcome is the amount of time (minutes) from end case to PACU discharge.
Time Frame End case to post anesthesia care unit (PACU) discharge. Time is measured continuously until PACU discharge, regardless of how long it takes.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Remifentanil Dexmedetomidine
Hide Arm/Group Description:

Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Overall Number of Participants Analyzed 91 68
Median (Inter-Quartile Range)
Unit of Measure: minutes
211
(183 to 228)
215
(184 to 236)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remifentanil, Dexmedetomidine
Comments Remifentanyl versus Dexmedetomidine on time to PACU discharge estimated using Cox proportional hazard regression
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
0.81 to 1.62
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Postoperative Nausea
Hide Description Indicator of whether patients had nausea or not
Time Frame Whether patients had nausea or not, from anesthesia stop time until hospital discharge.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Remifentanil Dexmedetomidine
Hide Arm/Group Description:

Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Overall Number of Participants Analyzed 71 68
Measure Type: Number
Unit of Measure: participants
12 12
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remifentanil, Dexmedetomidine
Comments Dexmedetomidine versus remifentanyl on postoperative nausea estimated from chi squared test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.91
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.5 to 2.2
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Postoperative Vomitting
Hide Description Indicator of whether patients had postoperative vomiting.
Time Frame Whether patients had vomiting or not, from anesthesia stop time until hospital discharge.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Remifentanil Dexmedetomidine
Hide Arm/Group Description:

Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Overall Number of Participants Analyzed 71 68
Measure Type: Number
Unit of Measure: participants
6 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remifentanil, Dexmedetomidine
Comments Dexmedetomidine versus remifentanyl on postoperative vomiting estimated from a chi square test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
0.07 to 1.7
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Postoperative Shivering
Hide Description Indicator of whether patients had postoperative shivering.
Time Frame Whether patients had postoperative or not, from anesthesia stop time until hospital discharge.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Remifentanil Dexmedetomidine
Hide Arm/Group Description:

Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Overall Number of Participants Analyzed 71 68
Measure Type: Number
Unit of Measure: participants
7 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remifentanil, Dexmedetomidine
Comments Dexmedetomidine versus remifentanyl on incidence of shivering estimated from a chi square test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
0.1 to 1.7
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Remifentanil Dexmedetomidine
Hide Arm/Group Description

Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS

a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

All-Cause Mortality
Remifentanil Dexmedetomidine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Remifentanil Dexmedetomidine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/71 (0.00%)   0/68 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Remifentanil Dexmedetomidine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/71 (0.00%)   0/68 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Daniel Sessler, MD
Organization: Cleveland Clinic
Phone: 216-445-6500
Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01269918     History of Changes
Other Study ID Numbers: 10-1056
First Submitted: December 22, 2010
First Posted: January 4, 2011
Results First Submitted: June 6, 2016
Results First Posted: December 20, 2016
Last Update Posted: December 20, 2016