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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ehab Farag, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01200433
First received: September 10, 2010
Last updated: May 5, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention
Deep Brain Stimulation (DBS)
Blood Flow
Brain Oxygenation
Drug: dexmedetomidine
Drug: propofol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Cerebral Blood Flow [ Time Frame: For patients randomized to dexmedetomideine: 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. ] [ Designated as safety issue: No ]
    Cerebral blood flow was the average of right and left carotid velocities recorded by transcranial Doppler.

  • Brain Oxygen [ Time Frame: during first and second study drug infusion periods ] [ Designated as safety issue: No ]
    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 PACU ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Alertness/Sedation [ Time Frame: at the first peak during DBS surgery ] [ Designated as safety issue: No ]
    Modified observer's assessment of alertness /sedation (OAA/S) scale which ranges from 0 to 5 (0 = dose 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Number of Hypertensive Episodes [ Time Frame: During DBS surgery ] [ Designated as safety issue: No ]
    The number of hypertensive episodes during Deep Brain Stimulation (DBS) surgery.

  • Number of Apneic Episodes. [ Time Frame: during DBS surgery ] [ Designated as safety issue: No ]
    The number of antihypertensive interventions during Deep Brain Stimulation (DBS) surgery.


Enrollment: 44
Study Start Date: October 2010
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: propofol
Subjects will be sedated with propofol.
Drug: 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.
Drug: 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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01200433

Locations
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Ehab Farag, MD The Cleveland Clinic
  More Information

Responsible Party: Ehab Farag, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01200433     History of Changes
Other Study ID Numbers: 10-715 
Study First Received: September 10, 2010
Results First Received: May 5, 2016
Last Updated: May 5, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
dexmedetomidine
propofol
cerebral blood flow
brain oxygenation

Additional relevant MeSH terms:
Propofol
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 21, 2016