Automated Anesthesia During Bronchoscopy

This study has been completed.
Sponsor:
Information provided by:
Hopital Foch
ClinicalTrials.gov Identifier:
NCT00571181
First received: December 9, 2007
Last updated: April 5, 2009
Last verified: April 2009
  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 4

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

Resource links provided by NLM:


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
Experimental: 1 Device: Closed-loop system
Automatic delivery of propofol and remifentanil
Active Comparator: 2 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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pr Fischler, Professor of Anesthesiology, Hopital Foch
ClinicalTrials.gov Identifier: NCT00571181     History of Changes
Other Study ID Numbers: 2007/14, EudraCT 2007-003157-82
Study First Received: December 9, 2007
Last Updated: April 5, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Anesthetics
Propofol
Remifentanil
Anesthetics, Intravenous
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, General
Hypnotics and Sedatives
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on April 15, 2014