Trial Outcomes & Findings for The Effects of Dexmedetomidine and Propofol on Cerebral Blood Flow and Brain Oxygenation During Deep Brain Stimulation (NCT NCT01200433)

NCT ID: NCT01200433

Last Updated: 2016-12-14

Results Overview

Cerebral blood flow was the average of right and left carotid velocities recorded by transcranial Doppler.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 44 participants
• Primary outcome timeframe: For patients randomized to dexmedetomidine: at the first peak of study drug (i.e., at peak dose of study drug during first infusion period); for patients randomized to propofol: when infusion of propofol stopped.
• Results posted on: 2016-12-14

Participant Flow

Participant milestones

Measure	Propofol Subjects will be sedated with propofol. propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient's response	Dexmedetomidine Subjects will be sedated with dexmedetomidine. dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure.
Overall Study STARTED	21	23
Overall Study COMPLETED	21	23
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effects of Dexmedetomidine and Propofol on Cerebral Blood Flow and Brain Oxygenation During Deep Brain Stimulation

Baseline characteristics by cohort

Measure	Propofol n=21 Participants Subjects will be sedated with propofol. propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient's response	Dexmedetomidine n=23 Participants Subjects will be sedated with dexmedetomidine. dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure.	Total n=44 Participants Total of all reporting groups
Age, Continuous	63.5 years STANDARD_DEVIATION 10.5 • n=93 Participants	65.4 years STANDARD_DEVIATION 6.8 • n=4 Participants	64.5 years STANDARD_DEVIATION 8.7 • n=27 Participants
Gender Female	3 Participants n=93 Participants	5 Participants n=4 Participants	8 Participants n=27 Participants
Gender Male	18 Participants n=93 Participants	18 Participants n=4 Participants	36 Participants n=27 Participants
Race/Ethnicity, Customized Caucasian	21 participants n=93 Participants	21 participants n=4 Participants	42 participants n=27 Participants
Race/Ethnicity, Customized Others	0 participants n=93 Participants	2 participants n=4 Participants	2 participants n=27 Participants

PRIMARY outcome

Timeframe: For patients randomized to dexmedetomidine: at the first peak of study drug (i.e., at peak dose of study drug during first infusion period); for patients randomized to propofol: when infusion of propofol stopped.

Cerebral blood flow was the average of right and left carotid velocities recorded by transcranial Doppler.

Outcome measures

Measure	Propofol n=21 Participants Subjects will be sedated with propofol. propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient's response	Dexmedetomidine n=23 Participants Subjects will be sedated with dexmedetomidine. dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure.
Cerebral Blood Flow	45.4 cm/sec Interval 37.0 to 48.0	39.9 cm/sec Interval 31.5 to 47.0

PRIMARY outcome

Timeframe: during first (10-20 minutes) and second (throughout the procedure) study drug infusion periods

Brain oxygenation values were estimated by near-infrared spectroscopy and brain oxygenation was averaged across the first and second study drug infusion periods.

Outcome measures

Measure	Propofol n=21 Participants Subjects will be sedated with propofol. propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient's response	Dexmedetomidine n=23 Participants Subjects will be sedated with dexmedetomidine. dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure.
Brain Oxygen	73.5 % oxygenation Interval 70.3 to 76.6	72.7 % oxygenation Interval 70.0 to 75.3

SECONDARY outcome

Timeframe: after procedure, in post anesthesia care unit (PACU)

Population: The cerebral flow at PACU was not planned as a primary outcome. The primary outcome was cerebral flow at the first peak of study drug. The data was collect for information purpose only. No test was done for cerebral blood flow at PACU.

The investigator will test the hypothesis that dexmedetomidine is non-inferior to propofol for cerebral blood flow as measured by transcranial Doppler and brain oxygenation as measured by near-infrared spectroscopy.

Outcome measures

Measure	Propofol n=21 Participants Subjects will be sedated with propofol. propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient's response	Dexmedetomidine n=23 Participants Subjects will be sedated with dexmedetomidine. dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure.
Cerebral Blood Flow	55 cm/sec Standard Deviation 18.1	46.7 cm/sec Standard Deviation 10.5

SECONDARY outcome

Timeframe: at the first peak during DBS surgery

Modified observer's assessment of alertness /sedation (OAA/S) scale which ranges from 0 to 5 (0 = does not respond to noxious stimuli and 5 = responds to name spoken in normal tone)

Outcome measures

Measure	Propofol n=21 Participants Subjects will be sedated with propofol. propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient's response	Dexmedetomidine n=23 Participants Subjects will be sedated with dexmedetomidine. dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure.
Alertness/Sedation	2 units on a scale Interval 1.0 to 2.0	3 units on a scale Interval 2.0 to 3.0

SECONDARY outcome

Timeframe: at the first peak during DBS surgery

Pulsatility index is a measure of the variability of blood velocity in a vessel, and was calculated as the difference between the peak systolic and minimum diastolic velocities divided by the mean velocity during the cardiac cycle.

Outcome measures

Measure	Propofol n=21 Participants Subjects will be sedated with propofol. propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient's response	Dexmedetomidine n=23 Participants Subjects will be sedated with dexmedetomidine. dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure.
Pulsatility Index	1 units on a scale Interval 0.89 to 1.05	1 units on a scale Interval 0.92 to 1.15

SECONDARY outcome

Timeframe: at the first peak during DBS surgery

Outcome measures

Measure	Propofol n=21 Participants Subjects will be sedated with propofol. propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient's response	Dexmedetomidine n=23 Participants Subjects will be sedated with dexmedetomidine. dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure.
Cerebral Perfusion Pressure	53.9 mmHg Interval 45.1 to 69.8	54.6 mmHg Interval 48.9 to 66.0

SECONDARY outcome

Timeframe: During DBS surgery

The number of hypertensive episodes during Deep Brain Stimulation (DBS) surgery.

Outcome measures

Measure	Propofol n=21 Participants Subjects will be sedated with propofol. propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient's response	Dexmedetomidine n=23 Participants Subjects will be sedated with dexmedetomidine. dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure.
Number of Hypertensive Episodes	4.9 number of episodes Standard Deviation 2.7	2.9 number of episodes Standard Deviation 2.5

SECONDARY outcome

Timeframe: during DBS surgery

The number of antihypertensive interventions during Deep Brain Stimulation (DBS) surgery.

Outcome measures

Measure	Propofol n=21 Participants Subjects will be sedated with propofol. propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient's response	Dexmedetomidine n=23 Participants Subjects will be sedated with dexmedetomidine. dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure.
Number of Apneic Episodes.	0 number of episodes Interval 0.0 to 0.0	0 number of episodes Interval 0.0 to 0.0

Adverse Events

Propofol

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

Ehab Farag, MD

Clevland Clinic Foundation

Phone: 216-444-9950

Email: farage@ccf.org

Results disclosure agreements

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