- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00392158
Manual Administration of Propofol-remifentanil Versus Dual Closed-loop Using Bispectral Index as the Control Variable
September 23, 2016 updated by: Hopital Foch
Target-controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by the Index Bispectral: Comparison Between Manual Perfusion and Automated Perfusion
To compare manual administration of propofol and remifentanil and dual closed-loop using bispectral index as the control variable during anesthesia
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The Bispectral Index (BIS) is an electroencephalogram-derived measure of anesthetic depth.
A closed-loop anesthesia system can be built using BIS as the control variable, a proportional-integral-differential control algorithm, and a propofol target-controlled infusion system as the control actuator.
Recent studies have shown that such system is able to provide clinically adequate anesthesia.
We hypothesized that BIS can also indicate the adequacy of analgesia and therefore 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.
In preparation for a large multi-center control trial, we propose a prospective randomized study to evaluate the effectiveness of such a closed-loop anesthesia system.
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.
Study Type
Interventional
Enrollment
240
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Argenteuil, France, 95100
- Dept of Anesthesia, CH d'Argenteuil
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Besançon, France, 25030
- Dept of Anesthesiology, CHU de Besançon
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Bordeaux, France, 33074
- Dept of Anesthesia, Clinique Saint Augustin
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Clichy, France, 92110
- Dept of Anesthesia and Intensive Care, Hôpital Beaujon
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Paris, France, 75014
- Dept of Anesthesiology, Hôpital Cochin
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Suresnes, France, 92150
- Dept of Anesthesia, Hôpital Foch
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- surgery under general anesthesia using relaxant agent,
- surgery lasting more than one hour
Exclusion Criteria:
- pregnant women,
- indication for rapid sequence induction,
- anticipation of difficult intubation,
- allergy to propofol or remifentanil,
- neurological or muscular disorder,
- combination of general anesthesia and of regional anesthesia,
- emergency surgery.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Global score (calculated parameter which depicts the performance of the system, i.e. its capacity to maintain BIS in the desired range)
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Secondary Outcome Measures
Outcome Measure |
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consumption of propofol and remifentanil during the induction and the maintenance of the anaesthesia
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number of modifications of target of propofol and remifentanil
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number of episodes of hemodynamic anomalies having required a treatment
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intraoperative volume loading and transfusion
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extubation time, explicit memorisation
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dysfunctions of each system
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marc Fischler, MD, Hôpital Foch
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95. doi: 10.1097/00000542-200604000-00012.
- Liu N, Chazot T, Trillat B, Pirracchio R, Law-Koune JD, Barvais L, Fischler M. Feasibility of closed-loop titration of propofol guided by the Bispectral Index for general anaesthesia induction: a prospective randomized study. Eur J Anaesthesiol. 2006 Jun;23(6):465-9. doi: 10.1017/S0265021506000196.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2006
Study Completion (Actual)
April 1, 2007
Study Registration Dates
First Submitted
October 24, 2006
First Submitted That Met QC Criteria
October 24, 2006
First Posted (Estimate)
October 25, 2006
Study Record Updates
Last Update Posted (Estimate)
September 26, 2016
Last Update Submitted That Met QC Criteria
September 23, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Foch-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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