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Automated Anesthesia Guided by the Conox Monitor for Surgery

NCT03540875 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2021-11-05

No results posted yet for this study

Summary

This study compares automated administration of propofol and remifentanil versus manual administration during general anesthesia for a surgery. The closed-loop coadministration of propofol and remifentanil is guided by qCon and qNox indexes from the Conox monitor.

Conditions

  • Anesthesia, General

Interventions

DEVICE

Closed loop anesthesia

Propofol and Remifentanil are administered automatically using a closed-loop system. The goal of this study is to compare manual titration versus automated titration of propofol and remifentanil in adult patients undergoing surgery guided by the electro-cortical activity. The aim in both group is to maintain the qCon in the range 40-60 during induction and maintenance of general anesthesia using the propofol in TCI mode. But also the qNox in the range 40-60 using remifentanil. The controller is based on a Proportional-Integral-derivative algorithm which steers a target to the pumps during induction and maintenance of general anesthesia.

DRUG

Propofol

The dosage is modified automatically by the device or according to the new medical prescription.

DRUG

Remifentanil

The dosage is modified automatically by the device or according to the new medical prescription.

Sponsors & Collaborators

  • CMC Ambroise Paré

    lead OTHER

Principal Investigators

  • Marc Fischler, MD · Hôpital Foch

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-02
Primary Completion
2019-02-18
Completion
2019-02-18

Countries

  • France

Study Locations

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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 NCT03540875 on ClinicalTrials.gov