Effects of Dexmedetomidine on the Intraoperative Electroencephalogram During Endarterectomy Surgery

Endarterectomy, Carotid Clinical Trial

Official title:

Effects of Dexmedetomidine on the Intraoperative Electroencephalogram During Endarterectomy Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00710437
• Other study ID #: 200513433
• Secondary ID: 200513433-120051
• Status: Completed
• Phase: N/A
• First received: July 2, 2008
• Last updated: May 24, 2017
• Start date: April 2005
• Est. completion date: November 2009

Study information

• Verified date: May 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients undergoing elective carotid endarterectomy

Exclusion Criteria:

• Emergency surgery

Related Conditions & MeSH terms

• Endarterectomy, Carotid

Intervention

Drug:
• Dexmedetomidine
Steady state infusion 0.007 mcg/kg/min

Locations

Country	Name	City	State
United States	University of California, Davis Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of Dexmedetomidine on the Intraoperative Electroencephalogram During Endarterectomy Surgery	Data collection and analysis complete. Permanently closed.	April 2005 - November 2009