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NCT Number: NCT04877574

ANI-guided Intraoperative Analgesia vs Conventional Intraoperative Analgesia

This study evaluates the effects of Analgesia Nociception Index (ANI)-guided intraoperative analgesia on postoperative pain in patients undergoing open gynecologic surgery.

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Key information

Conditions

Postoperative Pain Agnosia Analgesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms Surgery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

Postoperative pain is one of the most common postoperative complications and is significantly associated with patient's quality of recovery. Analgesia Nociception Index (ANI) is known to analyze the high frequency component of heart rate variability in relation to respiratory frequency, providing the objective information on the degree of pain. However, most previous studies conducted by using ANI were observational studies or small-sized randomized controlled studies. In the present study, the investigators aimed to evaluate the effects of ANI-guided intraoperative analgesia on moderate-to-severe postoperative pain by performing randomized controlled study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18
  • Elective open gynecological surgery
  • American Society of Anaesthesiologists physical status classification 1-3

Exclusion criteria

  • Laparoscopic surgery or robot-assisted surgery
  • Patients who had analgesic agents, anti-psychotic agents, anticonvulsants which were related to chronic pain
  • Patients who had hypersensitivity to analgesic agents or medications related anesthesia.
  • Patients who were required to have mechanical ventilation after surgery
  • Patients who had arrhythmia
  • Patients who transferred to the surgical intensive care unit immediately after surgery
  • Pregnancy

Treatment and study plan

ANI-guided intraoperative analgesia

Procedure

Intraoperative analgesia is performed by controlling the effect-site concentration of remifentanil to maintain 50-70 of ANI.

Conventional intraoperative analgesia

Procedure

Intraoperative analgesia is performed by controlling the effect-site concentration of remifentanil at the discretion of attending anesthesiologists based on hemodynamic parameters.

Primary outcomes

  1. the incidence of moderate-to-severe postoperative pain

    Time frame: during 1 hour of stay in the postanesthesia care unit

    the incidence of moderate-to-severe postoperative pain is defined as a case in which pain with numeric rating scale (NRS) of 5 or more is reported during stays in the postanesthesia care unit. Pain assessment is performed two times during stays in the postanesthesia care unit.

Secondary outcomes

  1. the amount of intraoperative remifentanil

    Time frame: intraoperative

    the amount of intraoperative remifentanil used during anesthesia

  2. Quality of Recovery-15 (QoR-15) score

    Time frame: at postoperative 24 hour

    QoR-15 questionnaire is recorded by an investigator. QoR-15 questionnaire has minimum score of 0 and maximum score of 150, and higher score indicates the better quality of recovery.

  3. the incidence of postoperative nausea and vomiting

    Time frame: at postoperative 1 hour, 24 hour, 72 hour

    the incidence of postoperative nausea and vomiting is recorded by an investigator

  4. 11-pointed NRS pain score

    Time frame: at postoperative 24 hour

    11-pointed NRS pain score is measured at both resting state and movement. 11-pointed NRS pain score has minimum score of 0 and maximum score of 10, and higher score indicates the higher severity of pain.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Effects of Analgesia Nociception Index (ANI)-Guided Intraoperative Analgesia on Postoperative Pain: a Randomized Controlled Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 7, 2021
Registry last updated
Sep 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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