Analgesia, Postoperative Pain, Surgery
Conditions
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.
Interventions
PROCEDUREANI-guided intraoperative analgesia
Intraoperative analgesia is performed by controlling the effect-site concentration of remifentanil to maintain 50-70 of ANI.
PROCEDUREConventional intraoperative analgesia
Intraoperative analgesia is performed by controlling the effect-site concentration of remifentanil at the discretion of attending anesthesiologists based on hemodynamic parameters.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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. |
Countries
South Korea
Outcome results
None listed