The Effects of Dexmedetomidine and Propofol on Cerebral Blood Flow and Brain Oxygenation During Deep Brain Stimulation
|ClinicalTrials.gov Identifier: NCT01200433|
Recruitment Status : Completed
First Posted : September 13, 2010
Results First Posted : June 13, 2016
Last Update Posted : December 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|Intracranial Neurosurgery||Drug: dexmedetomidine Drug: propofol||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
Active Comparator: propofol
Subjects will be sedated with 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
Active Comparator: dexmedetomidine
Subjects will be sedated with 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.
Other Name: Precedex
- Cerebral Blood Flow [ Time Frame: 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.
- Brain Oxygen [ Time Frame: 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.
- Cerebral Blood Flow [ Time Frame: after procedure, in post anesthesia care unit (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.
- Alertness/Sedation [ Time Frame: 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)
- Pulsatility Index [ Time Frame: 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.
- Cerebral Perfusion Pressure [ Time Frame: at the first peak during DBS surgery ]
- Number of Hypertensive Episodes [ Time Frame: During DBS surgery ]The number of hypertensive episodes during Deep Brain Stimulation (DBS) surgery.
- Number of Apneic Episodes. [ Time Frame: during DBS surgery ]The number of antihypertensive interventions during Deep Brain Stimulation (DBS) surgery.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01200433
|United States, Ohio|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Ehab Farag, MD||The Cleveland Clinic|