Manual Administration of Propofol-remifentanil Versus Dual Closed-loop Using Bispectral Index as the Control Variable
Target-controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by the Index Bispectral: Comparison Between Manual Perfusion and Automated Perfusion
1 other identifier
interventional
240
1 country
6
Brief Summary
To compare manual administration of propofol and remifentanil and dual closed-loop using bispectral index as the control variable during anesthesia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2006
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 24, 2006
CompletedFirst Posted
Study publicly available on registry
October 25, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedSeptember 26, 2016
September 1, 2016
October 24, 2006
September 23, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Global score (calculated parameter which depicts the performance of the system, i.e. its capacity to maintain BIS in the desired range)
Secondary Outcomes (6)
consumption of propofol and remifentanil during the induction and the maintenance of the anaesthesia
number of modifications of target of propofol and remifentanil
number of episodes of hemodynamic anomalies having required a treatment
intraoperative volume loading and transfusion
extubation time, explicit memorisation
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- surgery under general anesthesia using relaxant agent,
- surgery lasting more than one hour
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hopital Fochlead
Study Sites (6)
Dept of Anesthesia, CH d'Argenteuil
Argenteuil, 95100, France
Dept of Anesthesiology, CHU de Besançon
Besançon, 25030, France
Dept of Anesthesia, Clinique Saint Augustin
Bordeaux, 33074, France
Dept of Anesthesia and Intensive Care, Hôpital Beaujon
Clichy, 92110, France
Dept of Anesthesiology, Hôpital Cochin
Paris, 75014, France
Dept of Anesthesia, Hôpital Foch
Suresnes, 92150, France
Related Publications (2)
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.
PMID: 16571963BACKGROUNDLiu 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.
PMID: 16672092BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Marc Fischler, MD
Hôpital Foch
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 24, 2006
First Posted
October 25, 2006
Study Start
February 1, 2006
Study Completion
April 1, 2007
Last Updated
September 26, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share