Anesthesia Feasibility Study With the CONCERT-CL® Station

NCT02889718 | Completed Phase 2

• 1 other identifier: ICO-N-2014-07
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

anaesthesia with CONCERT-CL® station

EXPERIMENTAL

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

Device: CONCERT-CL® station; Other: Surgery

Interventions

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: * Port B = open loop: Analgesic * Port A = closed loop: Hypnotic * Port C = closed loop: Curare

anaesthesia with CONCERT-CL® station

Surgery OTHER

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

anaesthesia with CONCERT-CL® station

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• patients under supervision or unable to consent

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (1)

ICO

Saint-Herblain, 44805, France

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Surgical Procedures, Operative

Study Officials

• MAVOUNGOU Philippe, MD

  Institut de Cancérologie de l'Ouest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: September 7, 2016
• Study Start: February 16, 2015
• Primary Completion: December 15, 2016
• Study Completion: December 15, 2016
• Last Updated: May 16, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)