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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

July 2, 2008
July 6, 2012
April 2005
May 2009   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00710437 on ClinicalTrials.gov Archive Site
Not Provided
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Effects of Dexmedetomidine on the Intraoperative Electroencephalogram During Endarterectomy Surgery
Effects of Dexmedetomidine on the Intraoperative Electroencephalogram During Endarterectomy Surgery

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

Patients undergoing elective carotid endarterectomy

Endarterectomy, Carotid
Drug: Dexmedetomidine
Steady state infusion 0.007 mcg/kg/min
  • 1
    Dexmedetomidine - used
    Intervention: Drug: Dexmedetomidine
  • 2
    Dexmedetomidine - not used
    Intervention: Drug: Dexmedetomidine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
November 2009
May 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients undergoing elective carotid endarterectomy

Exclusion Criteria:

  • Emergency surgery
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00710437
200513433, 200513433-1, 200513433-2, 200513433-3, 200513433-4, 200513433-5
No
Neal Fleming, MD, PhD, University of California, Davis
University of California, Davis
Not Provided
Study Director: Neal W Fleming, M.D., Ph.D. Director, Cardiovascular and Thoracic Anesthesiology, UC Davis, Department of Anesthesiology and Pain Medicine
University of California, Davis
July 2012

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