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Automated Anesthesia During Bronchoscopy

H

Hopital Foch

Status and phase

Completed
Phase 4

Conditions

Anesthesia, General

Treatments

Device: Closed-loop system
Device: TCI (Infusion Toolbox)

Study type

Interventional

Funder types

Other

Identifiers

NCT00571181
2007/14
EudraCT 2007-003157-82

Details and patient eligibility

About

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.

Full 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.

Enrollment

66 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients undergoing rigid bronchoscopy under general anesthesia

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

66 participants in 2 patient groups

1
Experimental group
Treatment:
Device: Closed-loop system
2
Active Comparator group
Treatment:
Device: TCI (Infusion Toolbox)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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