Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effects of Dexmedetomidine and Remifentanil on Carotid Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00335972
Recruitment Status : Terminated (Closed due to lack of enrollment)
First Posted : June 12, 2006
Results First Posted : August 11, 2017
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition Carotid Artery Stenosis
Interventions Drug: Remifentanil
Drug: Dexmedetomidine
Enrollment 142
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Remifentanil Dexmedetomidine
Hide Arm/Group Description

Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical

Remifentanil: Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical

Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.

Dexmedetomidine: Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.

Period Title: Overall Study
Started 71 71
Completed 71 68
Not Completed 0 3
Reason Not Completed
not given treatments             0             3
Arm/Group Title Remifentanil Dexmedetomidine Total
Hide Arm/Group Description

Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical

Remifentanil: Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical

Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.

Dexmedetomidine: Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.

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) 55  (14)
Sex: Female, Male  
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%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 68 participants 139 participants
Race-white
65
  91.5%
57
  83.8%
122
  87.8%
Race-other
6
   8.5%
11
  16.2%
17
  12.2%
1.Primary Outcome
Title Mean Arterial Pressure
Hide Description [Not Specified]
Time Frame mean arterial pressure at 15, 30, 45, 60, and 90 minutes after extubation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Remifentanil Dexmedetomidine
Hide Arm/Group Description:

Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical

Remifentanil: Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical

Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.

Dexmedetomidine: Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.

Overall Number of Participants Analyzed 71 68
Mean (Standard Deviation)
Unit of Measure: mmHg
at 15 minutes after extubation 99  (12) 86  (13)
at 30 minutes after extubation 98  (12) 87  (13)
at 45 minutes after extubation 98  (13) 86  (13)
at 60 minutes after extubation 96  (12) 89  (15)
at 90 minutes after extubation 94  (12) 88  (13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remifentanil, Dexmedetomidine
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size was based on being able to detect noninferiority on both analgesia (pain score and opioids) and hemodynamic responses, and superiority on at least one of them with 90% power and significance level of 0.025 for each of noninferiority and superiority. For MAP with a noninferiority delta of 7.5 mmHg and expected the SD of 12, we needed a maximum of N= 65 per group. Incorporating the two interim and one final analyses, we thus planned a maximum sample size of N=71/group (N=142 total).
Statistical Test of Hypothesis P-Value <0.001
Comments Noninferiority confidence intervals are 95% (alpha of 0.05/2=0.025 in direction of interest). Bonferroni correction was used for superiority testing and 97.5% CI were reported.
Method repeated measures ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -9
Confidence Interval (2-Sided) 95%
-13 to -5
Estimation Comments mean difference: Dexmedetomidine arm - Remifentanil arm
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Remifentanil, Dexmedetomidine
Comments superiority test
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Bonferroni correction was used for superiority testing since superiority on either hemodynamics or pain control would be interpreted as Dex better than Remi (alpha=0.0125 = 0.025/2, 97.5% CI).
Method repeated measures ANOVA model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -9
Confidence Interval (2-Sided) 97.5%
-13 to -4
Estimation Comments mean difference: dexmedetomidine arm - remifentanil arm
2.Primary Outcome
Title Visual Analogue Scale (VAS) Pain Score
Hide Description Using a ruler, the score is determined by measuring the distance on the 10-cm line between the “no pain” anchor and the patient’s mark, providing a range of scores from 0–10. 0 = no pain and 10 = worst
Time Frame pain score measured at 15, 30, 45, 60, and 90 minutes after extubation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Remifentanil Dexmedetomidine
Hide Arm/Group Description:

Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical

Remifentanil: Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical

Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.

Dexmedetomidine: Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.

Overall Number of Participants Analyzed 71 68
Mean (Standard Deviation)
Unit of Measure: cm
at 15 minutes after extubation 5.4  (3.4) 2.6  (3.4)
at 30 minutes after extubation 5.3  (2.8) 2.8  (3.2)
at 45 minutes after extubation 5.0  (2.4) 3.1  (3.0)
at 60 minutes after extubation 4.9  (2.6) 2.9  (2.7)
at 90 minutes after extubation 4.8  (2.4) 2.9  (2.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remifentanil, Dexmedetomidine
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size was based on being able to detect noninferiority on both analgesia (pain score and opioids) and hemodynamic responses, and superiority on at least one of them with 90% power and significance level of 0.025 for each of noninferiority and superiority. For VRS pain, the standard deviation (SD) was expected to be about 1.75, such that with a noninferiority delta of 1, we needed a maximum of N= 66 per group
Statistical Test of Hypothesis P-Value <0.001
Comments noninferiority confidence intervals are 95% (alpha of 0.05/2=0.025 in direction of interest).
Method repeated measures ANOVA model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.9
Confidence Interval (2-Sided) 95%
-2.7 to -1.1
Estimation Comments mean difference: Dexmedetomidine arm - Remifentanil arm
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Remifentanil, Dexmedetomidine
Comments superiority test
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Bonferroni correction was used for superiority testing since superiority on either hemodynamics or pain control would be interpreted as Dex better than Remi (alpha=0.0125 = 0.025/2, 97.5% CI).
Method repeated measures ANOVA model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.9
Confidence Interval (2-Sided) 97.5%
-2.8 to -0.9
Estimation Comments mean difference: dexmedetomidine arm - remifentanil arm
3.Primary Outcome
Title Intravenous Morphine Equivalents During Post-anesthesia Care Unit (PACU) After Surgery
Hide Description intravenous morphine equivalents (mg)
Time Frame During Post-anesthesia care unit after surgery,an average of 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Remifentanil Dexmedetomidine
Hide Arm/Group Description:

Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical

Remifentanil: Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical

Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.

Dexmedetomidine: Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.

Overall Number of Participants Analyzed 71 68
Median (Inter-Quartile Range)
Unit of Measure: mg
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 [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size was based on being able to detect noninferiority on both analgesia (pain score and opioids) and hemodynamic responses, and superiority on at least one of them with 90% power and significance level of 0.025 for each of noninferiority and superiority.we needed a maximum of N= 65 per group. We assumed for opioids that the coefficient of variation (SD/mean) was about 0.4, resulting in a similar sample size (64/group) with noninferiority deltas of 20% of the observed mean
Statistical Test of Hypothesis P-Value <0.001
Comments noninferiority confidence intervals are 95% (alpha of 0.05/2=0.025 in direction of interest)
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -5
Confidence Interval (2-Sided) 95%
-10 to -5
Estimation Comments mean difference: Dexmedetomidine arm - Remifentanil
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Remifentanil, Dexmedetomidine
Comments superiority
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Bonferroni correction was used for superiority testing since superiority on either hemodynamics or pain control would be interpreted as Dex better than Remi (alpha=0.0125 = 0.025/2, 97.5% CI)
Method repeated measures ANOVA model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -5
Confidence Interval (2-Sided) 97.5%
-10 to -3
Estimation Comments mean difference: dexmedetomidine arm - remifentanil arm
Time Frame during Post-anesthesia care unit after surgery
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Remifentanil Dexmedetomidine
Hide Arm/Group Description

Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical

Remifentanil: Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical

Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.

Dexmedetomidine: Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.

All-Cause Mortality
Remifentanil Dexmedetomidine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/71 (0.00%)   0/68 (0.00%) 
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: Rafi Avitsian, M.D
Organization: Cleveland Clinic
Phone: (216)-444-9735
Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00335972     History of Changes
Other Study ID Numbers: 10-27-05
First Submitted: June 8, 2006
First Posted: June 12, 2006
Results First Submitted: January 31, 2017
Results First Posted: August 11, 2017
Last Update Posted: August 11, 2017