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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03498820

Acronym

MONIDOL-ANI

Enrollment

Registered

2018-04-17

Start date

2018-11-19

Completion date

2020-03-13

Last updated

2021-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Anesthesia

Keywords

Analgesia-Nociception Index (ANI), General anesthesia, Opioids, Remifentanil, Pain, Monitoring

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.

Interventions

DEVICEAnalgesia Nociception Index

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

DRUGRemifentanil

intravenous short-acting opioid routinely administered during general anesthesia

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
Persistent pain	: obtained one month after surgery	phone interview asking the patient if she still feels pain related to the surgery

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026