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

NCT01200433 | Completed Results

• 1 other identifier: 10-715
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Neurosurgery

Keywords

dexmedetomidine; propofol; cerebral blood flow; brain oxygenation

Outcome Measures

Primary Outcomes (2)

• Cerebral Blood Flow

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

  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.

• Brain Oxygen

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

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

Secondary Outcomes (6)

• Cerebral Blood Flow

  after procedure, in post anesthesia care unit (PACU)

• Alertness/Sedation

  at the first peak during DBS surgery

• Pulsatility Index

  at the first peak during DBS surgery

• Cerebral Perfusion Pressure

  at the first peak during DBS surgery

• Number of Hypertensive Episodes

  During DBS surgery

Study Arms (2)

propofol

ACTIVE COMPARATOR

Subjects will be sedated with propofol.

Drug: propofol

dexmedetomidine

ACTIVE COMPARATOR

Subjects will be sedated with dexmedetomidine.

Drug: dexmedetomidine

Interventions

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.

Also known as: Precedex

dexmedetomidine

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

propofol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-III.
• Scheduled for DBS.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Farag E, Kot M, Podolyak A, Argalious M, Deogaonkar M, Mascha EJ, Xu Z, Katzan I, Ebrahim Z. The relative effects of dexmedetomidine and propofol on cerebral blood flow velocity and regional brain oxygenation: A randomised noninferiority trial. Eur J Anaesthesiol. 2017 Nov;34(11):732-739. doi: 10.1097/EJA.0000000000000662.

  PMID: 28891839 DERIVED

MeSH Terms

Interventions

Dexmedetomidine; Propofol

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Ehab Farag, MD
• Organization: Clevland Clinic Foundation

farage@ccf.org

216-444-9950

Study Officials

• Ehab Farag, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 10, 2010
• First Posted: September 13, 2010
• Study Start: October 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: December 14, 2016
• Results First Posted: June 13, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)