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Automatic Remifentanil Administration Guided by ANI During Propofol Anesthesia

NCT03556696 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2026-02-20

No results posted yet for this study

Summary

Prospective Randomized Monocentric Clinical Trial during propofol anesthesia. The aim of the study is to test whether the use of a medical device designed to automatically administer remifentanil during surgery based on expert rules and continuous reading of heart rate, blood pressure and the Analgesia Nociception Index results in lower overall remifentanil administration versus standard practice.

Conditions

  • Nociceptive Pain
  • Surgical Procedure, Unspecified

Interventions

DEVICE

ANI-REMI-loop

experimental medical device using expert rules and continuous reading of heart rate, blood pressure and Analgesia Nociception Index for automatic remifentanil administration

DEVICE

remifentanil pK/pD target administration device

standard practice, remifentanil administration using Minto's pK/pD model

DRUG

Remifentanil

Remifentanil Ce target can range from 0 to 10 ng.ml-1. Remifentanil target is adapted in order to maintain Analgesia Nociception Index (MDMS, Loos, France) in the \[50-70\] range.

DRUG

Propofol

propofol is used for induction and maintenance of general anesthesia using Schnider pK/pD model. Propofol Ce target is adapted in order to maintain BiSpectral Index in \[40-60\] range

DEVICE

ANI monitor

ANI (Analgesia Nociception Index) value is used in the "std\_practice" arm for guidance of the remifentanil Ce target

Sponsors & Collaborators

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Mathieu JEANNE, MD,PhD · University Hospital, Lille

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-27
Primary Completion
2022-06-14
Completion
2022-11-22

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 NCT03556696 on ClinicalTrials.gov