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: Completed
• Conditions: Cancer; Surgery
• Intervention / Treatment: Device: CONCERT-CL® station; Other: Surgery

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • St herblain, France, 44805
    • ICO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: anaesthesia with CONCERT-CL® station; During the surgery, 3 drugs usually used for anaesthesia will be administered by the CONCERT-CL® station	Device: CONCERT-CL® station; 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; Other: Surgery; Regardless of the type of surgery the patient receives for his cancer, this surgery must be greater than 1 hour.

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

Collaborators and Investigators

• Sponsor: Institut Cancerologie de l'Ouest
• Investigators: Principal Investigator: MAVOUNGOU Philippe, MD, Institut de Cancérologie de l'Ouest

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2015
• Primary Completion (Actual): December 15, 2016
• Study Completion (Actual): December 15, 2016

Study Registration Dates

• First Submitted: August 25, 2016
• First Submitted That Met QC Criteria: August 30, 2016
• First Posted (Estimate): September 7, 2016

Study Record Updates

• Last Update Posted (Actual): May 16, 2019
• Last Update Submitted That Met QC Criteria: May 14, 2019
• Last Verified: May 1, 2019

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)?: NO