Effects of Dexmedetomidine on the Intraoperative Electroencephalogram During Endarterectomy Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-04-30

Study Completion Date

2009-11-30

Brief Summary

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During elective carotid endarterectomy surgery, dexmedetomidine, an FDA approved medication, is now given as part of our standard anesthetic regimen based upon its reported ability to decrease anesthetic requirements and improve the peri-operative hemodynamic profile without compromising the EEG monitoring that is used during these procedures. Although this is consistent with our clinical impression, the effects of dexmedetomidine on the perioperative course and EEG monitoring have not been objectively evaluated at our institution.

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Detailed Description

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Fifty sequential patient records will be identified from a search of the OR surgical schedules and reviewed: 25 patients before the introduction of dexmedetomidine and a standard anesthetic protocol and 25 patients after the introduction of the protocol. Data will be collected during an individual review of the pre-operative anesthetic evaluation, the intra-operative anesthetic record and the post-anesthesia care unit record and collated in an Excel spread sheet kept on a secure personal computer in the PI's office. All personal identifiers will be removed and the patients numbered sequentially before and after introduction of the clinical protocol. The data collected will be used to characterize the intraoperative anesthetic requirements, effects on EEG activity and the immediate postoperative recovery period. The review is expected to require 2 months to complete.

This review will be restricted to records that already exist. No therapeutically removed tissues will be collected. There will be no additional tests. No blood samples will be collected. No additional procedures are involved in this study activity. There is no incomplete disclosure.

The resources and personnel are currently available to complete this review. The entire project including data collection, analysis and summarization will be completed by the PI.

Conditions

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Endarterectomy, Carotid

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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1

Dexmedetomidine - used

Dexmedetomidine

Intervention Type DRUG

Steady state infusion 0.007 mcg/kg/min

2

Dexmedetomidine - not used

Dexmedetomidine

Intervention Type DRUG

Steady state infusion 0.007 mcg/kg/min

Interventions

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Dexmedetomidine

Steady state infusion 0.007 mcg/kg/min

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing elective carotid endarterectomy

Exclusion Criteria

* Emergency surgery

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neal W Fleming, M.D., Ph.D.

Role: STUDY_DIRECTOR

Director, Cardiovascular and Thoracic Anesthesiology, UC Davis, Department of Anesthesiology and Pain Medicine

Locations

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University of California, Davis Medical Center

Sacramento, California, United States

Site Status

Countries

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United States