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Automated Anesthesia During Bronchoscopy

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00571181
Enrollment
66
Registered
2007-12-11
Start date
2007-12-31
Completion date
2008-09-30
Last updated
2016-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, General

Keywords

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

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.

Interventions

Automatic delivery of propofol and remifentanil

DEVICETCI (Infusion Toolbox)

TCI administration of propofol and remifentanil

Sponsors

Hopital Foch
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients undergoing rigid bronchoscopy under general anesthesia

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Percentage of time with BIS in the desired rangeDuring the procedure

Secondary

MeasureTime frame
consumption of propofol and remifentanilduring the procedure
extubation timeduring the procedure
explicit memorisationpostoperative day 2

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026