ANI-guided Intraoperative Analgesia vs Conventional Intraoperative Analgesia
- Conditions
- SurgeryAnalgesiaPostoperative Pain
- Interventions
- Procedure: Conventional intraoperative analgesiaProcedure: ANI-guided intraoperative analgesia
- Registration Number
- NCT04877574
- Lead Sponsor
- Seoul National University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 170
- Age ≥ 18
- Elective open gynecological surgery
- American Society of Anaesthesiologists physical status classification 1-3
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional intraoperative analgesia 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. ANI-guided intraoperative analgesia ANI-guided intraoperative analgesia Intraoperative analgesia is performed by controlling the effect-site concentration of remifentanil to maintain 50-70 of ANI index.
- Primary Outcome Measures
Name Time Method the incidence of moderate-to-severe postoperative pain 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 Outcome Measures
Name Time Method the amount of intraoperative remifentanil intraoperative the amount of intraoperative remifentanil used during anesthesia
Quality of Recovery-15 (QoR-15) score 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.
11-pointed NRS pain score 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.
the incidence of postoperative nausea and vomiting at postoperative 1 hour, 24 hour, 72 hour the incidence of postoperative nausea and vomiting is recorded by an investigator
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of