Automated Anesthesia During Bronchoscopy - Full Text View

Sponsored by:	Hopital Foch
Information provided by:	Hopital Foch
ClinicalTrials.gov Identifier:	NCT00571181

Purpose

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.

Condition	Intervention	Phase
Anesthesia, General	Device: Closed-loop system Device: TCI (Infusion Toolbox)	Phase IV

MedlinePlus related topics: Anesthesia

Drug Information available for: Propofol Remifentanil Remifentanil hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Hopital Foch:

Primary Outcome Measures:

Percentage of time with BIS in the desired range [ Time Frame: During the procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

consumption of propofol and remifentanil [ Time Frame: during the procedure ] [ Designated as safety issue: No ]
extubation time [ Time Frame: during the procedure ] [ Designated as safety issue: No ]
explicit memorisation [ Time Frame: postoperative day 2 ] [ Designated as safety issue: Yes ]

Enrollment:	66
Study Start Date:	December 2007
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Device: Closed-loop system Automatic delivery of propofol and remifentanil
2: Active Comparator	Device: TCI (Infusion Toolbox) TCI administration of propofol and remifentanil

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patients undergoing rigid bronchoscopy under general anesthesia

Exclusion Criteria:

pregnant women
allergy to propofol or remifentanil
neurological disorder
psychotrop treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571181

Locations

France
Service d'Anesthésie, Hôpital Foch
Suresnes, France, 92150

Sponsors and Collaborators

Hopital Foch

Investigators

Study Chair:

Marc Fischler, MD

Hopital Foch

More Information

Publications:

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.

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.

Responsible Party:	Hopital Foch ( Pr Fischler, Professor of Anesthesiology )
Study ID Numbers:	2007/14, EudraCT 2007-003157-82
Study First Received:	December 9, 2007
Last Updated:	September 10, 2008
ClinicalTrials.gov Identifier:	NCT00571181
Health Authority:	France: Agence française de sécurité sanitaire des produits de santé

Keywords provided by Hopital Foch:

Algorithms
Anesthesia, General/*methods
Anesthetics, Intravenous/*administration & dosage
Drug Delivery Systems/*methods/statistics & numerical data
Electroencephalography/drug effects/*methods/
Feasibility Studies

Propofol/*administration & dosage
Remifentanil/*administration & dosage
Bronchoscopy/*methods
Prospective Studies
Software

Study placed in the following topic categories:

Remifentanil
Muscle Rigidity
Propofol

Additional relevant MeSH terms:

Anesthetics, Intravenous
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Pharmacologic Actions
Anesthetics, General
Sensory System Agents

Therapeutic Uses
Hypnotics and Sedatives
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 13, 2009