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

Not Applicable

Completed

• Conditions: Intracranial Neurosurgery
• Interventions: Drug: propofol; Drug: dexmedetomidine

• Registration Number: NCT01200433
• Lead Sponsor: The Cleveland Clinic

Brief Summary

The investigators will evaluate the effects of dexmedetomidine and propofol on cerebral blood flow and brain oxygenation during Deep Brain Stimulation (DBS) surgery. Specifically, the investigators 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-10
• Study First Submitted QC: 2010-09-10
• Study First Posted: 2010-09-13
• Study Start: 2010-10
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Results First Submitted: 2016-05-05
• Results First Submitted QC: 2016-05-05
• Results First Posted: 2016-06-13
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-31
• Last Update Posted: 2016-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• ASA I-III.
• Scheduled for DBS.

Exclusion Criteria

• History of dystonia.
• Severe heart failure with ejection fraction less than 30%.
• History of obstructive sleep apnea.
• History of renal failure with creatinine level > 2 mg/dl.
• Allergies to α-2 agonists and propofol.
• Current use of α-2 agonist medications such as clonidine.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
propofol	propofol	Subjects will be sedated with propofol.
dexmedetomidine	dexmedetomidine	Subjects will be sedated with dexmedetomidine.

Primary Outcome Measures

Name	Time	Method
Brain Oxygen	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	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.

Secondary Outcome Measures

Name	Time	Method
Number of Apneic Episodes.	during DBS surgery	The number of antihypertensive interventions during Deep Brain Stimulation (DBS) surgery.
Cerebral Perfusion Pressure	at the first peak during DBS surgery
Cerebral Blood Flow	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.
Pulsatility Index	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.
Number of Hypertensive Episodes	During DBS surgery	The number of hypertensive episodes during Deep Brain Stimulation (DBS) surgery.
Alertness/Sedation	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)

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States