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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-19

Study Completion Date

2020-03-13

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.

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Detailed Description

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Conditions

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Pain Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Analgesia Nociception Index

Intraoperative remifentanil administration guided by the Analgesia Nociception Index

Group Type EXPERIMENTAL

Analgesia Nociception Index

Intervention Type DEVICE

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

Usual practice

Intraoperative remifentanil administration managed in standard practice

Group Type ACTIVE_COMPARATOR

Remifentanil

Intervention Type DRUG

intravenous short-acting opioid routinely administered during general anesthesia

Interventions

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Analgesia Nociception Index

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

Intervention Type DEVICE

Remifentanil

intravenous short-acting opioid routinely administered during general anesthesia

Intervention Type DRUG

Other Intervention Names

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ANI

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No