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MONIDOL-ANI: Analgesia-Nociception Index Guided Intraoperative Remifentanil Administration Versus Standard Practice:Evaluation of Perioperative Opioid Use

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Completed
CT.gov ID
NCT03498820
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
15.8
Actual Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study compares two groups of patients undergoing a gynecological surgey under general anesthesia: one group in which intraoperative analgesia is guided by the Analgesia-nociception index, and another group in which intraoperative analgesia is managed as in standard practice. The objective is to assess if the Analgesia Nociception Index may result in a decrease in total analgesic drugs consumption, a decrease in post-operative pain and in chronic pain development.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
Analgesia-Nociception Index Guided Intraoperative Remifentanil Administration Versus Standard Practice : Evaluation of Perioperative Opioid Use
Actual Study Start Date :
Nov 19, 2018
Actual Primary Completion Date :
Dec 19, 2019
Actual Study Completion Date :
Mar 13, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Analgesia Nociception Index

Intraoperative remifentanil administration guided by the Analgesia Nociception Index

Device: Analgesia Nociception Index
: Non invasive monitor based on heart rate variability analysis, assessing the parasympathetic nervous activity
Other Names:
  • ANI

    		•
    Active Comparator: Usual practice

    Intraoperative remifentanil administration managed in standard practice

    Drug: Remifentanil
    intravenous short-acting opioid routinely administered during general anesthesia

    Outcome Measures

    Primary Outcome Measures

    1. Intraoperative remifentanil consumption [up to 7 hours after the beginning of general anesthesia]

      total dose of remifentanil administered to the patient during general anesthesia

    Secondary Outcome Measures

    1. Postoperative morphine consumption [obtained 24 hours after the end of general anesthesia]

      total dose of morphine administered to the patient to manage postoperative pain during the first 24 hours following surgery

    2. Persistent pain [: obtained one month after surgery]

      phone interview asking the patient if she still feels pain related to the surgery

    3. Persistent pain [Obtained three months after surgery]

      phone interview asking the patient if she still feels pain related to the surgery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Elective gynecological surgery under general anesthesia

    • Duration of surgery 1-7 hours

    • Duration of hospital stay > 24 hours

    Exclusion Criteria:

    • chronic pain

    • chronic analgesic medication

    • neurologic disease

    • psychiatric disease

    • history of addiction

    • kidney or liver failure

    • allergy to any anesthetic or analgesic drug

    • BMI > 35

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service d'Anesthésie-réanimation chirurgicale - Hôpital Trousseau Paris France 75012

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris

    Investigators

    • Principal Investigator: Nada SABOURDIN, MD, Assistance Publique - Hôpitaux de Paris

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT03498820
    Other Study ID Numbers:
    • P171003J
    First Posted:
    Apr 17, 2018
    Last Update Posted:
    May 24, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Assistance Publique - Hôpitaux de Paris
    Analgesia-Nociception Index (ANI)
    General anesthesia
    Opioids
    Remifentanil
    Pain
    Monitoring
    Additional relevant MeSH terms:
    Remifentanil

    Study Results

    No Results Posted as of May 24, 2021