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

Pain Clinical Trial

— MONIDOL-ANI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03498820
• Other study ID #: P171003J
• Status: Completed
• Phase: N/A
• Start date: November 19, 2018
• Est. completion date: March 13, 2020

Study information

• Verified date: May 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 13, 2020
• Est. primary completion date: December 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Pain

Intervention

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

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

Locations

Country	Name	City	State
France	Service d'Anesthésie-réanimation chirurgicale - Hôpital Trousseau	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Persistent pain	phone interview asking the patient if she still feels pain related to the surgery	: obtained one month after surgery
Secondary	Persistent pain	phone interview asking the patient if she still feels pain related to the surgery	Obtained three months after surgery