NCT00710437

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 4, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

4.1 years

First QC Date

July 2, 2008

Last Update Submit

May 24, 2017

Conditions

Endarterectomy, Carotid

Keywords

DexmedetomidineCarotid EndarterectomyElectroencephalogram

Outcome Measures

Primary Outcomes (1)

  • Effects of Dexmedetomidine on the Intraoperative Electroencephalogram During Endarterectomy Surgery

    Data collection and analysis complete. Permanently closed.

    April 2005 - November 2009

Study Arms (2)

1

Dexmedetomidine - used

Drug: Dexmedetomidine

2

Dexmedetomidine - not used

Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG

Steady state infusion 0.007 mcg/kg/min

12

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing elective carotid endarterectomy

You may qualify if:

  • Patients undergoing elective carotid endarterectomy

You may not qualify if:

  • Emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Neal W Fleming, M.D., Ph.D.

    Director, Cardiovascular and Thoracic Anesthesiology, UC Davis, Department of Anesthesiology and Pain Medicine

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2008

First Posted

July 4, 2008

Study Start

April 1, 2005

Primary Completion

May 1, 2009

Study Completion

November 1, 2009

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

US(1)