Automated Anesthesia During Bronchoscopy

Anesthesia, General Clinical Trial

Official title:

Target-Controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by the Index Bispectral: Comparison Between Manual Perfusion and Automated Perfusion During Rigid Bronchoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00571181
• Other study ID #: 2007/14
• Secondary ID: EudraCT 2007-003
• Status: Completed
• Phase: Phase 4
• First received: December 9, 2007
• Last updated: September 22, 2016
• Start date: December 2007
• Est. completion date: September 2008

Study information

• Verified date: September 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients undergoing rigid bronchoscopy under general anesthesia

Exclusion Criteria:

• pregnant women

• allergy to propofol or remifentanil

• neurological disorder

• psychotrop treatment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia, General

Intervention

Device:
• Closed-loop system
Automatic delivery of propofol and remifentanil
• TCI (Infusion Toolbox)
TCI administration of propofol and remifentanil

Locations

Country	Name	City	State
France	Service d'Anesthésie, Hôpital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

References & Publications (2)

Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloë 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. — View Citation

Liu N, Chazot T, Trillat B, Pirracchio R, Law-Koune JD, Barvais L, Fischler M. Feasibility of closed-loop titration of propofol guided by the Bispectral Index for general anaesthesia induction: a prospective randomized study. Eur J Anaesthesiol. 2006 Jun;23(6):465-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of time with BIS in the desired range		During the procedure	No
Secondary	consumption of propofol and remifentanil		during the procedure	No
Secondary	extubation time		during the procedure	No
Secondary	explicit memorisation		postoperative day 2	Yes