Anesthesia Feasibility Study With the CONCERT-CL® Station

Cancer Clinical Trial

— CONCERT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02889718
• Other study ID #: ICO-N-2014-07
• Status: Completed
• Phase: Phase 2
• Start date: February 16, 2015
• Est. completion date: December 15, 2016

Study information

• Verified date: May 2019
• Source: Institut Cancerologie de l'Ouest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 15, 2016
• Est. primary completion date: December 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Surgery

Intervention

Device:
• 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

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

Locations

Country	Name	City	State
France	ICO	St herblain

Sponsors (1)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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