NCT00391963

Brief Summary

To compare Bispectral index and entropy during maintenance of anesthesia

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2006

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

June 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

January 15, 2009

Status Verified

January 1, 2009

First QC Date

October 24, 2006

Last Update Submit

January 14, 2009

Conditions

Anesthesia, General

Interventions

Bispectral index, EntropyDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 18 years,
  • American Society of Anesthesiologists physical status 1-3,
  • surgery under general anesthesia using propofol, sufentanil, and a relaxant agent,
  • surgery lasting more than one hour,
  • tracheal extubation planned at end of surgery

You may not qualify if:

  • pregnant women,
  • allergy to propofol,
  • neurological or muscular disorder,
  • treatment with opioids or any psychoactive medication,
  • cardiac surgery,
  • thyroid disorder,
  • emergency surgery,
  • prone or lateral decubitus position (difficulty to have a correct probe position)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dept of Anesthesia and Intensive Care, Hôpital Beaujon

Clichy, 92110, France

Location

Dept of Anesthesiology, Hôpital Foch

Suresnes, 92150, France

Location

Related Publications (3)

  • Schmidt GN, Bischoff P, Standl T, Hellstern A, Teuber O, Schulte Esch J. Comparative evaluation of the Datex-Ohmeda S/5 Entropy Module and the Bispectral Index monitor during propofol-remifentanil anesthesia. Anesthesiology. 2004 Dec;101(6):1283-90. doi: 10.1097/00000542-200412000-00007.

    PMID: 15564934BACKGROUND

  • Vanluchene AL, Vereecke H, Thas O, Mortier EP, Shafer SL, Struys MM. Spectral entropy as an electroencephalographic measure of anesthetic drug effect: a comparison with bispectral index and processed midlatency auditory evoked response. Anesthesiology. 2004 Jul;101(1):34-42. doi: 10.1097/00000542-200407000-00008.

    PMID: 15220769BACKGROUND

  • Aime I, Gayat E, Fermanian C, Cook F, Peuch C, Laloe PA, Mantz J, Fischler M. Effect of age on the comparability of bispectral and state entropy indices during the maintenance of propofol-sufentanil anaesthesia. Br J Anaesth. 2012 Apr;108(4):638-43. doi: 10.1093/bja/aer457. Epub 2012 Jan 17.

    PMID: 22258203DERIVED

Study Officials

  • Marc Fischler, MD

    Hôpital Foch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 24, 2006

First Posted

October 25, 2006

Study Start

June 1, 2006

Study Completion

April 1, 2007

Last Updated

January 15, 2009

Record last verified: 2009-01

Locations

FR(2)