Anesthesia Feasibility Study With the CONCERT-CL® Station

NCT ID: NCT02889718

Last Updated: 2019-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-16
• Study Completion Date: 2016-12-15

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.

Conditions

Cancer; Surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

anaesthesia with CONCERT-CL® station

During the surgery, 3 drugs usually used for anaesthesia will be administered by the CONCERT-CL® station

Group Type: EXPERIMENTAL

CONCERT-CL® station

Intervention Type: DEVICE

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

Surgery

Intervention Type: OTHER

Regardless of the type of surgery the patient receives for his cancer, this surgery must be greater than 1 hour.

Interventions

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

Intervention Type: DEVICE

Surgery

Regardless of the type of surgery the patient receives for his cancer, this surgery must be greater than 1 hour.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Cancerologie de l'Ouest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MAVOUNGOU Philippe, MD

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancérologie de l'Ouest

Locations

ICO

Saint-Herblain, , France

Countries

France

Other Identifiers

ICO-N-2014-07

Identifier Type: -

Identifier Source: org_study_id