Anesthesia Feasibility Study With the CONCERT-CL® Station

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02889718

Acronym

CONCERT

Enrollment

Registered

2016-09-07

Start date

2015-02-16

Completion date

2016-12-15

Last updated

2019-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Surgery

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.

Interventions

DEVICECONCERT-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

OTHERSurgery

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026