Anesthesia Feasibility Study With the CONCERT-CL® Station (CONCERT)
Anesthesia Feasibility Study With the CONCERT-CL® Station: Administration of Hypnotic in Closed Loop and Administration of Morphine in TCI Mode, at Constant Concentration, After Initial Calibration With a Pupillometer
This is a feasibility study of anesthesia in closed loop with the CONCERT-CL® station, on the effect of the hypnotic agent, measured by the bispectral index of the electroencephalogram, to maintain the hypnosis level within the recommended limits for general anesthesia. The analgesic agent is administered in "Target-Controlled Infusion = TCI" and analgesia evaluated by pupillometry.
This is a prospective, open, non-controlled, non-randomized, monocentric study. The main objective is to study the potential contribution of the system in the conduct of anaesthesia, as decision support, for the administration of the hypnotic agent.
Secondary objectives will include hemodynamic stability, and the average concentrations of opioid and hypnotic anesthetic agents evaluated from the pharmacokinetic model.
The study will involve surgical patients scheduled for surgery under general anesthesia for more than 1 (one) hour.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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St herblain, France, 44805
- ICO
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- men and women aged 18 years old and over
- Surgery of any type programmed for longer than 1 hour
- Anesthesia combining three agents: hypnotic, morphine, curare
Exclusion Criteria:
- minor patient
- pregnant and lactating women
- Known or suspected hypersensitivity to propofol,
- known or suspected hypersensitivity to remifentanil and other fentanyl derivatives,
- known or suspected hypersensitivity to rocuronium and atracurium, preventing the use of the two products.
- peanut allergy, soy, Egg
- neurological disease history with known modification of the electroencephalogram
- severe eye disease, ocular implant, standing diabetes with diabetic retinopathy
- gravis
- pacemakers patient
- surgery whose position is not suitable for a monitoring on the ulnar nave
- general anesthesia associated with regional anesthesia
- Simultaneous use of shortwave therapy or microwave
- Simultaneous use of high frequency surgical apparatus
- 15 patients under supervision or unable to consent
- patient undergoing psychiatric care
- patient in a health or social institution
- emergency
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: anaesthesia with CONCERT-CL® station
During the surgery, 3 drugs usually used for anaesthesia will be administered by the CONCERT-CL® station
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During cancer surgery (surgery > 1 hour), CONCERT-CL® station will be used in accordance with its CE marking to administer anesthetic agents:
Regardless of the type of surgery the patient receives for his cancer, this surgery must be greater than 1 hour.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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During anaesthesia, feasibility of administering hypnotic closed loop with CL® CONCERT station
Time Frame: From start of anesthesia until the release of the patient from recovery room
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The evaluation will measure the level of hypnosis during surgery. => The performance of the closed loop of the CONCERT-CL® station will be evaluated by studying its overall score (GS). |
From start of anesthesia until the release of the patient from recovery room
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: MAVOUNGOU Philippe, MD, Institut de Cancérologie de l'Ouest
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ICO-N-2014-07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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