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OpenTrials
Completed

NCT Number: NCT00571181

Automated Anesthesia During Bronchoscopy

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Service d'Anesthésie, Hôpital Foch

Suresnes, 92150, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients undergoing rigid bronchoscopy under general anesthesia

Exclusion criteria

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

Treatment and study plan

Closed-loop system

Device

Automatic delivery of propofol and remifentanil

TCI (Infusion Toolbox)

Device

TCI administration of propofol and remifentanil

Primary outcomes

  1. Percentage of time with BIS in the desired range

    Time frame: During the procedure

Secondary outcomes

  1. consumption of propofol and remifentanil

    Time frame: during the procedure

  2. extubation time

    Time frame: during the procedure

  3. explicit memorisation

    Time frame: postoperative day 2

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 11, 2007
Registry last updated
Sep 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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