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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain, Anesthesia

Intervention / Treatment
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* Device: Analgesia Nociception Index
* Drug: Remifentanil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Analgesia Nociception Index<br>Intraoperative remifentanil administration guided by the Analgesia Nociception Index | Device: Analgesia Nociception Index<br>* : Non invasive monitor based on heart rate variability analysis, assessing the parasympathetic nervous activity<br>* Other names: ANI;|
| Active Comparator: Usual practice<br>Intraoperative remifentanil administration managed in standard practice | Drug: Remifentanil<br>* intravenous short-acting opioid routinely administered during general anesthesia<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgesia-Nociception Index (ANI), General anesthesia, Opioids, Remifentanil, Pain, Monitoring