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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Pain; Anesthesia

Treatments: Device: Analgesia Nociception Index; Drug: Remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT03498820

P171003J

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Analgesia Nociception Index

Experimental group

Description:

Intraoperative remifentanil administration guided by the Analgesia Nociception Index

Treatment:

Device: Analgesia Nociception Index

Usual practice

Active Comparator group

Description:

Intraoperative remifentanil administration managed in standard practice

Treatment:

Drug: Remifentanil