Anesthesia Feasibility Study With the CONCERT-CL® Station

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Cancer, Surgery

Intervention / Treatment
-----------------
* Device: CONCERT-CL® station
* Other: Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: anaesthesia with CONCERT-CL® station<br>During the surgery, 3 drugs usually used for anaesthesia will be administered by the CONCERT-CL® station | Device: CONCERT-CL® station<br>* During cancer surgery (surgery > 1 hour), CONCERT-CL® station will be used in accordance with its CE marking to administer anesthetic agents: Port B = open loop: Analgesic Port A = closed loop: Hypnotic Port C = closed loop: Curare<br>Other: Surgery<br>* Regardless of the type of surgery the patient receives for his cancer, this surgery must be greater than 1 hour.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| During anaesthesia, feasibility of administering hypnotic closed loop with CL® CONCERT station | 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 |