Automated Anesthesia During Bronchoscopy

NCT ID: NCT00571181

Last Updated: 2016-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2008-09-30

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.

Conditions

Anesthesia, General

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Closed-loop system

Intervention Type: DEVICE

Automatic delivery of propofol and remifentanil

2

Group Type: ACTIVE_COMPARATOR

TCI (Infusion Toolbox)

Intervention Type: DEVICE

TCI administration of propofol and remifentanil

Interventions

Closed-loop system

Automatic delivery of propofol and remifentanil

Intervention Type: DEVICE

TCI (Infusion Toolbox)

TCI administration of propofol and remifentanil

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• patients undergoing rigid bronchoscopy under general anesthesia

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hopital Foch

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Fischler, MD

Role: STUDY_CHAIR

Hopital Foch

Locations

Service d'Anesthésie, Hôpital Foch

Suresnes, , France

Countries

France

References

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. doi: 10.1017/S0265021506000196.

Reference Type: BACKGROUND

PMID: 16672092 (View on PubMed)

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)

Liu N, Pruszkowski O, Leroy JE, Chazot T, Trillat B, Colchen A, Gonin F, Fischler M. Automatic administration of propofol and remifentanil guided by the bispectral index during rigid bronchoscopic procedures: a randomized trial. Can J Anaesth. 2013 Sep;60(9):881-7. doi: 10.1007/s12630-013-9986-7. Epub 2013 Jul 16.

Reference Type: DERIVED

PMID: 23857041 (View on PubMed)

Other Identifiers

EudraCT 2007-003157-82

Identifier Type: -

Identifier Source: secondary_id

2007/14

Identifier Type: -

Identifier Source: org_study_id