ANI-guided Intraoperative Analgesia vs Conventional Intraoperative Analgesia

NCT ID: NCT04877574

Last Updated: 2022-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2022-07-15

Brief Summary

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

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.

Conditions

Postoperative Pain; Analgesia; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

ANI-guided intraoperative analgesia

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

Group Type: EXPERIMENTAL

ANI-guided intraoperative analgesia

Intervention Type: PROCEDURE

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

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.

Group Type: ACTIVE_COMPARATOR

Conventional intraoperative analgesia

Intervention Type: PROCEDURE

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

Interventions

ANI-guided intraoperative analgesia

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

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hee-Soo Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2104-033-1209

Identifier Type: -

Identifier Source: org_study_id