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.

Study Overview

• Status: Completed
• Conditions: Endarterectomy, Carotid
• Intervention / Treatment: Drug: Dexmedetomidine

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: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California, Davis Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective carotid endarterectomy

Description

Inclusion Criteria:

• Patients undergoing elective carotid endarterectomy

Exclusion Criteria:

• Emergency surgery

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of Dexmedetomidine on the Intraoperative Electroencephalogram During Endarterectomy Surgery	Data collection and analysis complete. Permanently closed.	April 2005 - November 2009

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: April 1, 2005
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: July 2, 2008
• First Submitted That Met QC Criteria: July 2, 2008
• First Posted (Estimate): July 4, 2008

Study Record Updates

• Last Update Posted (Actual): May 30, 2017
• Last Update Submitted That Met QC Criteria: May 24, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Electroencephalogram; Dexmedetomidine; Carotid Endarterectomy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 200513433; 200513433-1 (Other Identifier: UC Davis, Institutional Review Board); 200513433-2 (Other Identifier: UC Davis, Institutional Review Board); 200513433-3 (Other Identifier: UC Davis, Institutional Review Board); 200513433-4 (Other Identifier: UC Davis, Institutional Review Board); 200513433-5 (Other Identifier: UC Davis, Institutional Review Board)