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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
History of Changes
  Purpose

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.


Condition Intervention
Endarterectomy, Carotid
 Drug: Dexmedetomidine

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Effects of Dexmedetomidine on the Intraoperative Electroencephalogram During Endarterectomy Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • 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.


Enrollment: 22
Study Start Date: April 2005
Study Completion Date: November 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Dexmedetomidine - used
 Drug: Dexmedetomidine
Steady state infusion 0.007 mcg/kg/min
2
Dexmedetomidine - not used
 Drug: Dexmedetomidine
Steady state infusion 0.007 mcg/kg/min

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing elective carotid endarterectomy

Criteria

Inclusion Criteria:

  • Patients undergoing elective carotid endarterectomy

Exclusion Criteria:

  • Emergency surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00710437

Locations
United States, California
University of California, Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
Study Director: Neal W Fleming, M.D., Ph.D. Director, Cardiovascular and Thoracic Anesthesiology, UC Davis, Department of Anesthesiology and Pain Medicine
  More Information

No publications provided

Responsible Party: Neal Fleming, MD, PhD, Professor, University of California, Davis
ClinicalTrials.gov Identifier: NCT00710437     History of Changes
Other Study ID Numbers: 200513433, 200513433-1, 200513433-2, 200513433-3, 200513433-4, 200513433-5
Study First Received: July 2, 2008
Last Updated: July 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
Dexmedetomidine
Carotid Endarterectomy
Electroencephalogram

Additional relevant MeSH terms:
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013