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

October 31, 2016 updated by: Ehab Farag, The Cleveland Clinic
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
during first (10-20 minutes) and second (throughout the procedure) study drug infusion periods

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
after procedure, in post anesthesia care unit (PACU)
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)
at the first peak during DBS surgery
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.
at the first peak during DBS surgery
Cerebral Perfusion Pressure
Time Frame: at the first peak during DBS surgery
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.
During DBS surgery
Number of Apneic Episodes.
Time Frame: during DBS surgery
The number of antihypertensive interventions during Deep Brain Stimulation (DBS) surgery.
during DBS surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

September 10, 2010

First Submitted That Met QC Criteria

September 10, 2010

First Posted (Estimate)

September 13, 2010

Study Record Updates

Last Update Posted (Estimate)

December 14, 2016

Last Update Submitted That Met QC Criteria

October 31, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-715

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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