Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-03-05 @ 4:54 PM
Study NCT ID:
NCT02889718
Status:
COMPLETED
Last Update Posted:
2019-05-16
First Post:
2016-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anesthesia Feasibility Study With the CONCERT-CL® Station
Sponsor:
Institut Cancerologie de l'Ouest
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONCERT
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: