NCT00393003

Brief Summary

This prospective randomized study evaluates the effectiveness of a closed-loop anesthesia system during the postoperative period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at below P25 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
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

August 31, 2009

Status Verified

August 1, 2009

Enrollment Period

7 months

First QC Date

October 24, 2006

Last Update Submit

August 28, 2009

Conditions

Postoperative Sedation

Keywords

AnesthesiaSedation

Outcome Measures

Primary Outcomes (1)

  • Global score (calculated parameter which depicts the performance of the system)

Secondary Outcomes (1)

  • Consumption of propofol and remifentanil, modifications of target of propofol and remifentanil, dysfunction of each system, hemodynamic abnormalities, sedation scale, volume loading, extubation time, explicit memorisation.

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
  • Abdominal aorta surgery

You may not qualify if:

  • Pregnant women
  • Neurological or muscular disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dept of Anesthesia and Intensive Care, Hopital Pitié-Salpêtrière

Paris, 75013, France

Location

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

  • Morgan Le Guen, MD

    Dept of Anesthesia and Intensive Care, Hopital Pitié-Salpêtrière, 75013 Paris, France

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 24, 2006

First Posted

October 26, 2006

Study Start

September 1, 2006

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

August 31, 2009

Record last verified: 2009-08

Locations

FR(2)