Anesthesia Feasibility Study With the CONCERT-CL® Station

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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Key information

Conditions

Cancer Neoplasms Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ICO

Saint-Herblain, 44805, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

SURGERY

Other

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

Primary outcomes

During anaesthesia, feasibility of administering hypnotic closed loop with CL® CONCERT station

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Registry information

Official study title

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

Acronym: CONCERT

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Sep 7, 2016
Registry last updated: May 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed