Skip to main content
OpenTrials
Completed

NCT Number: NCT03498820

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Anesthesia Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service d'Anesthésie-réanimation chirurgicale - Hôpital Trousseau

Paris, 75012, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Analgesia Nociception Index

Device

: Non invasive monitor based on heart rate variability analysis, assessing the parasympathetic nervous activity

Other names: ANI

Remifentanil

Drug

intravenous short-acting opioid routinely administered during general anesthesia

Primary outcomes

  1. Intraoperative remifentanil consumption

    Time frame: up to 7 hours after the beginning of general anesthesia

    total dose of remifentanil administered to the patient during general anesthesia

Secondary outcomes

  1. Postoperative morphine consumption

    Time frame: 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

    Time frame: : obtained one month after surgery

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

  3. Persistent pain

    Time frame: Obtained three months after surgery

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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: MONIDOL-ANI

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Apr 17, 2018
Registry last updated
May 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.