Clinical trial NCT02889718: Anesthesia Feasibility Study With the CONCERT-CL® Station
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer
Surgery
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: During anaesthesia, feasibility of administering hypnotic closed loop with CL® CONCERT station
timeFrame: From start of anesthesia until the release of the patient from recovery room
Secondary outcomes:
Other outcomes:
Locations:
city: St herblain
country: France
facility: ICO
Study officials:
affiliation: Institut de Cancérologie de l'Ouest
name: MAVOUNGOU Philippe, MD
role: PRINCIPAL_INVESTIGATOR
References: