Automated Anesthesia During Bronchoscopy

Phase 4

Completed

• Conditions: Anesthesia, General
• Interventions: Device: Closed-loop system; Device: TCI (Infusion Toolbox)

• Registration Number: NCT00571181
• Lead Sponsor: Hopital Foch

Brief Summary

The purpose of this study is to compare manual administration of propofol and remifentanil and dual closed-loop using bispectral index as the control variable during rigid bronchoscopy.

Detailed Description

The Bispectral Index (BIS) is an electroencephalogram-derived measure of anesthetic depth. We have built a combined closed-loop anesthesia system 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. A recent study has shown that such system is able to provide clinically adequate anesthesia. The aim of the present study is to assess the system during rigid bronchoscopy. 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 anesthesia system group to do similar or better.

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-09
• Study First Submitted QC: 2007-12-09
• Study First Posted: 2007-12-11
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-22
• Last Update Posted: 2016-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• patients undergoing rigid bronchoscopy under general anesthesia

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Exclusion Criteria

• pregnant women
• allergy to propofol or remifentanil
• neurological disorder
• psychotrop treatment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Closed-loop system	-
2	TCI (Infusion Toolbox)	-

Primary Outcome Measures

Name	Time	Method
Percentage of time with BIS in the desired range	During the procedure

Secondary Outcome Measures

Name	Time	Method
consumption of propofol and remifentanil	during the procedure
extubation time	during the procedure
explicit memorisation	postoperative day 2

Trial Locations

Locations (1)

Service d'Anesthésie, Hôpital Foch; 🇫🇷 Suresnes, France