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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anaesthesia with CONCERT-CL® station | Experimental | During the surgery, 3 drugs usually used for anaesthesia will be administered by the CONCERT-CL® station |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CONCERT-CL® station | Device | During cancer surgery (surgery > 1 hour), CONCERT-CL® station will be used in accordance with its CE marking to administer anesthetic agents:
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MAVOUNGOU Philippe, MD | Institut de Cancérologie de l'Ouest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICO | Saint-Herblain | 44805 | France |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Surgery | Other | Regardless of the type of surgery the patient receives for his cancer, this surgery must be greater than 1 hour. |
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