Influence of Muscle Relaxation on a Closed-loop Anesthesia System
Drone-Curare
Effect of Continuous Myorelaxation on the Need for Hypnotic Agent During Surgical Procedures Which do Not Require it (Multicenter, Randomized and Prospective Study)
1 other identifier
interventional
140
1 country
3
Brief Summary
Total intra-venous anesthesia can be provided using a closed-loop system guided by the bispectral index. The purpose of this study is to determine if myorelaxation modifies its functioning.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2009
Longer than P75 for phase_3
3 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
First Submitted
Initial submission to the registry
April 19, 2009
CompletedFirst Posted
Study publicly available on registry
April 23, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedSeptember 23, 2016
September 1, 2016
5.2 years
April 19, 2009
September 22, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
propofol dose
one hour anesthesia
Secondary Outcomes (7)
remifentanil dose
one hour anesthesia
number of automatic modifications of the propofol and remifentanil concentrations
one hour anesthesia
number of patients' movements
one hour anesthesia
number of hemodynamic abnormalities requiring treatment
one hour anesthesia
time to wake up
end of anesthesia
- +2 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATORTotal intravenous anesthesia (propofol and remifentanil) is provided using the close-loop system. A muscle relaxant is used to facilitate tracheal intubation; its administration is continued throughout anesthesia.
2
EXPERIMENTALTotal intravenous anesthesia (propofol and remifentanil) is provided using the close-loop system. No muscle relaxant is used and a placebo is infused throughout anesthesia.
Interventions
Eligibility Criteria
You may qualify if:
- patients scheduled for a surgical procedure which not require a myorelaxation
You may not qualify if:
- age less than 18 years,
- ASA III and above,
- pregnant woman
- combined general and regional anesthesia,
- history of prolonged myorelaxation due to a decrease in cholinesterase,
- patient with a known lack in cholinesterase,
- history of cerebral or psychiatric central,
- allergy to latex, propofol, remifentanil, morphine, muscle relaxant or any of the excipients,
- known hypersensitivity to remifentanil or to an other derivative of fentanyl,
- presence of a pacemaker,
- psychotropic or agonist-antagonist morphine treatment,
- planned post-operative sedation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hopital Fochlead
Study Sites (3)
CHU Besançon
Besançon, 25000, France
Institut Paoli-Calmette
Marseille, 13273, France
Hôpital Foch
Suresnes, 92151, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Marc Fischler, MD
Hôpital Foch
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2009
First Posted
April 23, 2009
Study Start
December 1, 2009
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
September 23, 2016
Record last verified: 2016-09