Clinical trial NCT00710437: Effects of Dexmedetomidine on the Intraoperative Electroencephalogram During Endarterectomy Surgery
Official title: Effects of Dexmedetomidine on the Intraoperative Electroencephalogram During Endarterectomy Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endarterectomy, Carotid
Keywords: Dexmedetomidine
Carotid Endarterectomy
Electroencephalogram
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2008-07-04
Enrollment: 22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective carotid endarterectomy

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.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective carotid endarterectomy

Exclusion Criteria:

* Emergency surgery

Primary outcomes:
measure: Effects of Dexmedetomidine on the Intraoperative Electroencephalogram During Endarterectomy Surgery
timeFrame: April 2005 - November 2009
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
Study officials:
affiliation: Director, Cardiovascular and Thoracic Anesthesiology, UC Davis, Department of Anesthesiology and Pain Medicine
name: Neal W Fleming, M.D., Ph.D.
role: STUDY_DIRECTOR
References: