Target-controlled Infusion of Propofol and Remifentanil for Postoperative Sedation Guided by the Bispectral Index

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-04-30

Brief Summary

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

Detailed Description

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The Bispectral Index (BIS) is an electroencephalogram-derived measure of anesthetic depth. A closed-loop anesthesia system can be built using BIS as the control variable, two proportional-integral-differential control algorithms, a propofol and a remifentanil target-controlled infusion systems as the control actuators. Preliminary results show that this system can be used during surgery. We propose a prospective randomized study to evaluate the effectiveness of such a closed-loop anesthesia system during the postoperative period. Two groups of patients are compared: one in which propofol and remifentanil are administered by the anesthesiologist using target-controlled infusion systems, and one in which propofol and remifentanil are administered automatically by the combined closed-loop anesthesia system. In both groups, the goal is to maintain BIS between 40 and 60, the recommended range during anesthesia by the manufacturer. We expect the combined closed-loop system group to do similar or better.

Conditions

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Postoperative Sedation

Keywords

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Anesthesia Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Closed-loop anesthesia system

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists physical status 1-3
* Abdominal aorta surgery

Exclusion Criteria

* Pregnant women
* Neurological or muscular disorder

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Hopital Foch

Principal Investigators

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Morgan Le Guen, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Dept of Anesthesia and Intensive Care, Hopital Pitié-Salpêtrière

Paris, , France

Site Status

Hôpital Foch

Suresnes, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND

PMID: 16571963 (View on PubMed)

Other Identifiers

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Foch-1

Identifier Type: -

Identifier Source: org_study_id