Effects of Analgesia Nociception Index (ANI)-Guided Intraoperative Analgesia on Postoperative Pain: a Randomized Controlled Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Postoperative Pain
- Sponsor
- Seoul National University Hospital
- Enrollment
- 170
- Locations
- 1
- Primary Endpoint
- the incidence of moderate-to-severe postoperative pain
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Hee-Soo Kim
Professor
Seoul National University Hospital
Eligibility Criteria
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
the incidence of moderate-to-severe postoperative pain
Time Frame: 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 Outcomes
- the amount of intraoperative remifentanil(intraoperative)
- Quality of Recovery-15 (QoR-15) score(at postoperative 24 hour)
- 11-pointed NRS pain score(at postoperative 24 hour)
- the incidence of postoperative nausea and vomiting(at postoperative 1 hour, 24 hour, 72 hour)