NCT02889718

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Institut Cancerologie de l'Ouest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-02-16
• Primary completion: 2016-12-15
• Completion: 2016-12-15
• First posted: 2016-09-07
• Last updated: 2019-05-16

Locations

1 site across 1 country: France