Anesthesia Feasibility Study With the CONCERT-CL® Station

Phase 2

Completed

• Conditions: Surgery; Cancer
• Interventions: Device: CONCERT-CL® station; Other: Surgery

• Registration Number: NCT02889718
• Lead Sponsor: Institut Cancerologie de l'Ouest

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-16
• Study First Submitted: 2016-08-25
• Study First Submitted QC: 2016-08-30
• Study First Posted: 2016-09-07
• Primary Completion: 2016-12-15
• Study Completion: 2016-12-15
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-14
• Last Update Posted: 2019-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
anaesthesia with CONCERT-CL® station	Surgery	During the surgery, 3 drugs usually used for anaesthesia will be administered by the CONCERT-CL® station
anaesthesia with CONCERT-CL® station	CONCERT-CL® station	During the surgery, 3 drugs usually used for anaesthesia will be administered by the CONCERT-CL® station

Primary Outcome Measures

Name	Time	Method
During anaesthesia, feasibility of administering hypnotic closed loop with CL® CONCERT station	From start of anesthesia until the release of the patient from recovery room	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).

Trial Locations

Locations (1)

ICO; 🇫🇷 St herblain, France