NCT00391885

Brief Summary

This study compares the manual administration of propofol and remifentanil and their delivery using a combined closed-loop anesthesia system, entropy of the EEG being the controller.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_4

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

September 1, 2006

Completed
2 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
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

6 months

First QC Date

October 24, 2006

Last Update Submit

September 26, 2016

Conditions

Anesthesia, General

Outcome Measures

Primary Outcomes (1)

  • Global score (calculated parameter which depicts the performance of the system, i.e. its capacity to maintain BIS in the desired range)

Secondary Outcomes (6)

  • consumption of propofol and remifentanil during the induction and the maintenance of the anaesthesia

  • number of modifications of target of propofol and remifentanil

  • number of episodes of hemodynamic anomalies having required a treatment

  • intraoperative volume loading and transfusion

  • extubation time, explicit memorisation

  • +1 more secondary outcomes

Interventions

Closed-loop anesthesia systemDEVICE

Eligibility Criteria

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

You may qualify if:

  • American Society of Anesthesiologists physical status 1-3,
  • surgery under general anesthesia using relaxant agent,
  • surgery lasting more than one hour

You may not qualify if:

  • pregnant women,
  • indication for rapid sequence induction,
  • anticipation of difficult intubation,
  • allergy to propofol or remifentanil,
  • neurological or muscular disorder,
  • combination of general anesthesia and of regional anesthesia,
  • emergency surgery

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 (1)

  • Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95. doi: 10.1097/00000542-200604000-00012.

    PMID: 16571963BACKGROUND

Study Officials

  • Marc Fischler, MD

    Hôpital Foch

    STUDY CHAIR

  • Marc Fischler, MD

    Hôpital Foch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2006

First Posted

October 25, 2006

Study Start

September 1, 2006

Primary Completion

March 1, 2007

Study Completion

April 1, 2007

Last Updated

September 27, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)