Overview

This trial is active, not recruiting.

Conditions deep brain stimulation (dbs), blood flow, brain oxygenation
Treatments dexmedetomidine, propofol
Sponsor The Cleveland Clinic
Start date October 2010
End date December 2013
Trial size 44 participants
Trial identifier NCT01200433, 10-715

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Arm
(Active Comparator)
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
(Active Comparator)
Subjects will be sedated with dexmedetomidine.
dexmedetomidine Precedex
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.

Primary Outcomes

Measure
cerebral blood flow
time frame: few minutes before procedure
cerebral blood flow
time frame: during procedure
cerebral blood flow
time frame: after procedure, in PACU

Secondary Outcomes

Measure
alertness/sedation
time frame: after sedation
sub-thalamic nucleus (STN)
time frame: after sedation
globus pallidum (GPi)
time frame: after sedation
Arterial oxygen saturation
time frame: after sedation
Number of apneic episodes.
time frame: after sedation

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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.

Additional Information

Principal investigator Ehab Farag, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by The Cleveland Clinic.