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

NCT ID: NCT01200433

Last Updated: 2016-12-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Intracranial Neurosurgery

Keywords

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dexmedetomidine propofol cerebral blood flow brain oxygenation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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propofol

Subjects will be sedated with propofol.

Group Type ACTIVE_COMPARATOR

propofol

Intervention Type 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

dexmedetomidine

Subjects will be sedated with dexmedetomidine.

Group Type ACTIVE_COMPARATOR

dexmedetomidine

Intervention Type 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.

Interventions

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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.

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Precedex

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Ehab Farag

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ehab Farag, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 28891839 (View on PubMed)

Other Identifiers

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10-715

Identifier Type: -

Identifier Source: org_study_id