Automatic Remifentanil Administration Guided by ANI During Propofol Anesthesia

NCT03556696 | Completed

• 2 other identifiers: 2016_482017-A00858-45
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

general anesthesia; analgesia/nociception balance monitoring; expert system

Outcome Measures

Primary Outcomes (1)

• normalized remifentanil administration

  ratio of total amount of administered remifentanil with body weight and duration of administration

  During the surgery, an average Three hours and a half

Secondary Outcomes (13)

• hemodynamic reactivity or bradycardia or hypotension

  During the surgery, an average Three hours and a half

• total administered ephedrine

  duration of general anesthesia

• Analgesia Nociception Index (ANI)

  During the surgery, an average Three hours and a half

• Bispectral Index (BIS)

  During the surgery, an average Three hours and a half

• Change antinociception/nociception balance status

  5 min before start of nociception, 5 min after start of nociception and 20 min after start of nociception

Study Arms (2)

ANI-loop

EXPERIMENTAL

arm 1 : remifentanil is automatically administered by a medical device using expert rules and continuous reading of heart rate, blood pressure and Analgesia Nociception Index (MDMS, Loos, France)

Device: ANI-REMI-loop; Drug: Remifentanil; Drug: Propofol

std_practice

ACTIVE COMPARATOR

arm 2: remifentanil is administered by a target control device using Minto's remifentanil pK/pD model. This is standard practice for this type of surgery at the Burn Center of the University Hospital of Lille, France.

Device: remifentanil pK/pD target administration device; Drug: Remifentanil; Drug: Propofol; Device: ANI monitor

Interventions

ANI-REMI-loop DEVICE

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

ANI-loop

remifentanil pK/pD target administration device DEVICE

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

std_practice

Remifentanil DRUG

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.

ANI-loop; std_practice

Propofol DRUG

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

ANI-loop; std_practice

ANI monitor DEVICE

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

Also known as: PhysioDoloris (MDMS, Loos, France)

std_practice

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA 1, 2 or 3 adult patients scheduled to undergo burn wound surgery at the Burn Center of the University Hospital of Lille

You may not qualify if:

• BMI outside \[17 - 35 kg/m2\]
• pregnancy or breast feeding women
• non sinus cardiac rhythm
• documented dysautonomia
• complicated diabetes mellitus
• known allergy to a drug used in the clinical trial

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital Roger Salengro, CHU

Lille, France

Location

Related Publications (1)

• De Jonckheere J, Jeanne M, Keribedj A, Delecroix M, Logier R. Closed-loop administration of analgesic drugs based on heart rate variability analysis. Annu Int Conf IEEE Eng Med Biol Soc. 2018 Jul;2018:506-509. doi: 10.1109/EMBC.2018.8512330.

  PMID: 30440445 RESULT

MeSH Terms

Conditions

Nociceptive Pain; Agnosia

Interventions

Remifentanil; Propofol

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Mathieu JEANNE, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Monocentric prospective randomized controlled clinical trial * arm 1: medical device automatically administering remifentanil, guided by expert rules and continuous reading of heart rate, blood pressure and Analgesia Nociception Index (MDMS, Loos, France) * arm 2 : standard practice : remifentanil is administered using a target controlled device using a pK/pD model of Minto

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: June 14, 2018
• Study Start: June 27, 2018
• Primary Completion: June 14, 2022
• Study Completion: November 22, 2022
• Last Updated: February 20, 2026

Record last verified: 2022-11

Locations

FR (1)