ANI-guided Intraoperative Analgesia vs Conventional Intraoperative Analgesia

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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Analgesia; Surgery
• Intervention / Treatment: Procedure: ANI-guided intraoperative analgesia; Procedure: Conventional intraoperative analgesia

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ANI-guided intraoperative analgesia; Intraoperative analgesia is performed by controlling the effect-site concentration of remifentanil to maintain 50-70 of ANI index.	Procedure: ANI-guided intraoperative analgesia; Intraoperative analgesia is performed by controlling the effect-site concentration of remifentanil to maintain 50-70 of ANI.
ACTIVE_COMPARATOR: Conventional intraoperative analgesia; Intraoperative analgesia is performed by controlling the effect-site concentration of remifentanil at the discretion of attending anesthesiologists based on hemodynamic parameters.	Procedure: Conventional intraoperative analgesia; Intraoperative analgesia is performed by controlling the effect-site concentration of remifentanil at the discretion of attending anesthesiologists based on hemodynamic parameters.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence of moderate-to-severe postoperative pain	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.	during 1 hour of stay in the postanesthesia care unit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the amount of intraoperative remifentanil	the amount of intraoperative remifentanil used during anesthesia	intraoperative
Quality of Recovery-15 (QoR-15) score	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.	at postoperative 24 hour
the incidence of postoperative nausea and vomiting	the incidence of postoperative nausea and vomiting is recorded by an investigator	at postoperative 1 hour, 24 hour, 72 hour
11-pointed NRS pain score	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.	at postoperative 24 hour

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2021
• Primary Completion (ACTUAL): July 11, 2022
• Study Completion (ACTUAL): July 15, 2022

Study Registration Dates

• First Submitted: April 30, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (ACTUAL): May 7, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 19, 2022
• Last Update Submitted That Met QC Criteria: September 15, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 2104-033-1209

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No