Effects of Dexmedetomidine on the Intraoperative Electroencephalogram During Endarterectomy Surgery

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Neal Fleming, MD, PhD, University of California, Davis

ClinicalTrials.gov Identifier:

NCT00710437

First received: July 2, 2008

Last updated: July 6, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 2, 2008

Last Updated Date

July 6, 2012

Start Date ^ICMJE

April 2005

Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Effects of Dexmedetomidine on the Intraoperative Electroencephalogram During Endarterectomy Surgery [ Time Frame: April 2005 - November 2009 ] [ Designated as safety issue: No ]

Data collection and analysis complete. Permanently closed.

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00710437 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effects of Dexmedetomidine on the Intraoperative Electroencephalogram During Endarterectomy Surgery

Official Title ^ICMJE

Effects of Dexmedetomidine on the Intraoperative Electroencephalogram During Endarterectomy Surgery

Brief Summary

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.

Detailed Description

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing elective carotid endarterectomy

Condition ^ICMJE

Endarterectomy, Carotid

Intervention ^ICMJE

Drug: Dexmedetomidine

Steady state infusion 0.007 mcg/kg/min

Study Group/Cohort (s)

1
Dexmedetomidine - used

Intervention: Drug: Dexmedetomidine
2
Dexmedetomidine - not used

Intervention: Drug: Dexmedetomidine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2009

Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients undergoing elective carotid endarterectomy

Exclusion Criteria:

Emergency surgery

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00710437

Other Study ID Numbers ^ICMJE

200513433, 200513433-1, 200513433-2, 200513433-3, 200513433-4, 200513433-5

Has Data Monitoring Committee

Responsible Party

Neal Fleming, MD, PhD, University of California, Davis

Study Sponsor ^ICMJE

University of California, Davis

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

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

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

Information Provided By

University of California, Davis

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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