ANI-guided Intraoperative Analgesia vs Conventional Intraoperative Analgesia

Seoul National University

Status: Completed

Conditions: Postoperative Pain; Surgery; Analgesia

Treatments: Procedure: Conventional intraoperative analgesia; Procedure: ANI-guided intraoperative analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT04877574

2104-033-1209

Details and patient eligibility

About

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

Full 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.

Enrollment: 170 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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170 participants in 2 patient groups

ANI-guided intraoperative analgesia

Experimental group

Description:

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

Treatment:

Procedure: ANI-guided intraoperative analgesia

Conventional intraoperative analgesia

Active Comparator group

Description:

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

Treatment:

Procedure: Conventional intraoperative analgesia