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Anesthesia Feasibility Study With the CONCERT-CL® Station

NCT02889718 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-05-16

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Institut Cancerologie de l'Ouest

    lead OTHER

Principal Investigators

  • MAVOUNGOU Philippe, MD · Institut de Cancérologie de l'Ouest

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-16
Primary Completion
2016-12-15
Completion
2016-12-15

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02889718 on ClinicalTrials.gov