Completed

NCT Number: NCT01200433

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

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.

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Key information

Conditions

Intracranial Neurosurgery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

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 names: Precedex

Propofol

Drug

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

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: Sep 13, 2010
Registry last updated: Dec 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.