Trial Outcomes & Findings for The Effects of Dexmedetomidine and Remifentanil on Carotid Patients (NCT NCT00335972)

NCT ID: NCT00335972

Last Updated: 2017-08-11

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 142 participants
• Primary outcome timeframe: mean arterial pressure at 15, 30, 45, 60, and 90 minutes after extubation
• Results posted on: 2017-08-11

Participant Flow

Participant milestones

Measure	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 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 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 Study STARTED	71	71
Overall Study COMPLETED	71	68
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Measure	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 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 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 Study not given treatments	0	3

Baseline Characteristics

The Effects of Dexmedetomidine and Remifentanil on Carotid Patients

Baseline characteristics by cohort

Measure	Remifentanil n=71 Participants 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 n=68 Participants 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 n=139 Participants Total of all reporting groups
Age, Continuous	55 years STANDARD_DEVIATION 14 • n=5 Participants	56 years STANDARD_DEVIATION 14 • n=7 Participants	55 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	33 Participants n=7 Participants	70 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	35 Participants n=7 Participants	69 Participants n=5 Participants
Race/Ethnicity, Customized Race-white	65 Participants n=5 Participants	57 Participants n=7 Participants	122 Participants n=5 Participants
Race/Ethnicity, Customized Race-other	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: mean arterial pressure at 15, 30, 45, 60, and 90 minutes after extubation

Outcome measures

Measure	Remifentanil n=71 Participants 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 n=68 Participants 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.
Mean Arterial Pressure at 15 minutes after extubation	99 mmHg Standard Deviation 12	86 mmHg Standard Deviation 13
Mean Arterial Pressure at 30 minutes after extubation	98 mmHg Standard Deviation 12	87 mmHg Standard Deviation 13
Mean Arterial Pressure at 45 minutes after extubation	98 mmHg Standard Deviation 13	86 mmHg Standard Deviation 13
Mean Arterial Pressure at 60 minutes after extubation	96 mmHg Standard Deviation 12	89 mmHg Standard Deviation 15
Mean Arterial Pressure at 90 minutes after extubation	94 mmHg Standard Deviation 12	88 mmHg Standard Deviation 13

PRIMARY outcome

Timeframe: pain score measured at 15, 30, 45, 60, and 90 minutes after extubation

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

Outcome measures

Measure	Remifentanil n=71 Participants 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 n=68 Participants 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.
Visual Analogue Scale (VAS) Pain Score at 15 minutes after extubation	5.4 cm Standard Deviation 3.4	2.6 cm Standard Deviation 3.4
Visual Analogue Scale (VAS) Pain Score at 30 minutes after extubation	5.3 cm Standard Deviation 2.8	2.8 cm Standard Deviation 3.2
Visual Analogue Scale (VAS) Pain Score at 45 minutes after extubation	5.0 cm Standard Deviation 2.4	3.1 cm Standard Deviation 3.0
Visual Analogue Scale (VAS) Pain Score at 60 minutes after extubation	4.9 cm Standard Deviation 2.6	2.9 cm Standard Deviation 2.7
Visual Analogue Scale (VAS) Pain Score at 90 minutes after extubation	4.8 cm Standard Deviation 2.4	2.9 cm Standard Deviation 2.8

PRIMARY outcome

Timeframe: During Post-anesthesia care unit after surgery,an average of 4 hours

intravenous morphine equivalents (mg)

Outcome measures

Measure	Remifentanil n=71 Participants 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 n=68 Participants 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.
Intravenous Morphine Equivalents During Post-anesthesia Care Unit (PACU) After Surgery	10 mg Interval 7.0 to 15.0	5 mg Interval 0.0 to 10.0

Adverse Events

Remifentanil

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dexmedetomidine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rafi Avitsian, M.D

Cleveland Clinic

Phone: (216)-444-9735

Email: avitsir@ccf.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place