Automated Anesthesia During Bronchoscopy

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Anesthesia, General

Intervention / Treatment
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* Device: Closed-loop system
* Device: TCI (Infusion Toolbox)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing rigid bronchoscopy under general anesthesia Exclusion Criteria: pregnant women allergy to propofol or remifentanil neurological disorder psychotrop treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: Closed-loop system<br>* Automatic delivery of propofol and remifentanil<br>|
| Active Comparator: 2<br> | Device: TCI (Infusion Toolbox)<br>* TCI administration of propofol and remifentanil<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of time with BIS in the desired range |  | During the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| consumption of propofol and remifentanil |  | during the procedure | 
| extubation time |  | during the procedure | 
| explicit memorisation |  | postoperative day 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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