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

Not Applicable

Completed

• Conditions: Pain; Anesthesia
• Interventions: Device: Analgesia Nociception Index; Drug: Remifentanil

• Registration Number: NCT03498820
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-26
• Study First Submitted QC: 2018-04-13
• Study First Posted: 2018-04-17
• Study Start: 2018-11-19
• Primary Completion: 2019-12-19
• Study Completion: 2020-03-13
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-21
• Last Update Posted: 2021-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Analgesia Nociception Index	Analgesia Nociception Index	Intraoperative remifentanil administration guided by the Analgesia Nociception Index
Usual practice	Remifentanil	Intraoperative remifentanil administration managed in standard practice

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 three months after surgery	phone interview asking the patient if she still feels pain related to the surgery

Trial Locations

Locations (1)

Service d'Anesthésie-réanimation chirurgicale - Hôpital Trousseau; 🇫🇷 Paris, France