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

This study is currently recruiting participants.
Verified June 2011 by Outcomes Research Consortium
Sponsor:
Information provided by:
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT01200433
First received: September 10, 2010
Last updated: June 13, 2011
Last verified: June 2011
History of Changes
  Purpose

To 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:

U.S. FDA Resources

Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:
  • cerebral blood flow [ Time Frame: few minutes before procedure ] [ Designated as safety issue: No ]
    We 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.

  • cerebral blood flow [ Time Frame: during procedure ] [ Designated as safety issue: No ]
    We 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.

  • cerebral blood flow [ Time Frame: after procedure, in PACU ] [ Designated as safety issue: No ]
    We 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: after sedation ] [ Designated as safety issue: No ]
    Modified observer's assessment of alertness /sedation (OAA/S)

  • sub-thalamic nucleus (STN) [ Time Frame: after sedation ] [ Designated as safety issue: No ]
    Recordings from the sub-thalamic nucleus (STN) and segment of the globus pallidus (GPi).

  • globus pallidus (GPi) [ Time Frame: after sedation ] [ Designated as safety issue: No ]
    Recordings from the sub-thalamic nucleus (STN) and segment of the globus pallidus (GPi).

  • Arterial oxygen saturation [ Time Frame: after sedation ] [ Designated as safety issue: No ]
    The number of antihypertensive interventions during Deep Brain Stimulation (DBS) insertion.

  • Number of apneic episodes. [ Time Frame: after sedation ] [ Designated as safety issue: No ]
    The number of antihypertensive interventions during Deep Brain Stimulation (DBS) insertion.


Estimated Enrollment: 44
Study Start Date: October 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01200433

Contacts
Contact: Gretchen A Upton 216-444-3289 uptong@ccf.org

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

No publications provided

Responsible Party: Ehab Farag, MD, Cleveland Clinic Foundation
ClinicalTrials.gov Identifier: NCT01200433     History of Changes
Other Study ID Numbers: 10-715
Study First Received: September 10, 2010
Last Updated: June 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Outcomes Research Consortium:
dexmedetomidine
propofol
cerebral blood flow
brain oxygenation

Additional relevant MeSH terms:
Propofol
Dexmedetomidine
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
 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 May 16, 2013