ANI-guided Intraoperative Analgesia vs Conventional Intraoperative Analgesia

NCT04877574 | Completed DMC

• 1 other identifier: 2104-033-1209
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Pain; Analgesia; Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• the amount of intraoperative remifentanil

  intraoperative

• Quality of Recovery-15 (QoR-15) score

  at postoperative 24 hour

• the incidence of postoperative nausea and vomiting

  at postoperative 1 hour, 24 hour, 72 hour

• 11-pointed NRS pain score

  at postoperative 24 hour

Study Arms (2)

ANI-guided intraoperative analgesia

EXPERIMENTAL

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

Procedure: ANI-guided intraoperative analgesia

Conventional intraoperative analgesia

ACTIVE COMPARATOR

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

Interventions

ANI-guided intraoperative analgesia PROCEDURE

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

ANI-guided intraoperative analgesia

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.

Conventional intraoperative analgesia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 7, 2021
• Study Start: July 1, 2021
• Primary Completion: July 11, 2022
• Study Completion: July 15, 2022
• Last Updated: September 19, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)