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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Anesthesia
• Intervention / Treatment: Device: Analgesia Nociception Index; Drug: Remifentanil

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75012
    • Service d'Anesthésie-réanimation chirurgicale - Hôpital Trousseau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative remifentanil consumption	total dose of remifentanil administered to the patient during general anesthesia	up to 7 hours after the beginning of general anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative morphine consumption	total dose of morphine administered to the patient to manage postoperative pain during the first 24 hours following surgery	obtained 24 hours after the end of general anesthesia
Persistent pain	phone interview asking the patient if she still feels pain related to the surgery	: obtained one month after surgery
Persistent pain	phone interview asking the patient if she still feels pain related to the surgery	Obtained three months after surgery

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2018
• Primary Completion (Actual): December 19, 2019
• Study Completion (Actual): March 13, 2020

Study Registration Dates

• First Submitted: February 26, 2018
• First Submitted That Met QC Criteria: April 13, 2018
• First Posted (Actual): April 17, 2018

Study Record Updates

• Last Update Posted (Actual): May 24, 2021
• Last Update Submitted That Met QC Criteria: May 21, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Remifentanil; Pain; Monitoring; Opioids; General anesthesia; Analgesia-Nociception Index (ANI)
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Remifentanil
• Other Study ID Numbers: P171003J

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No