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This study evaluates the effects of Analgesia Nociception Index (ANI)-guided intraoperative analgesia on postoperative pain in patients undergoing open gynecologic surgery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ANI-guided intraoperative analgesia | Experimental | Intraoperative analgesia is performed by controlling the effect-site concentration of remifentanil to maintain 50-70 of ANI index. |
|
| Conventional intraoperative analgesia | Active Comparator | Intraoperative analgesia is performed by controlling the effect-site concentration of remifentanil at the discretion of attending anesthesiologists based on hemodynamic parameters. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANI-guided intraoperative analgesia | Procedure | Intraoperative analgesia is performed by controlling the effect-site concentration of remifentanil to maintain 50-70 of ANI. |
|
| Measure | Description | Time Frame |
|---|---|---|
| the incidence of moderate-to-severe postoperative pain | 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. | during 1 hour of stay in the postanesthesia care unit |
| Measure | Description | Time Frame |
|---|---|---|
| the amount of intraoperative remifentanil | the amount of intraoperative remifentanil used during anesthesia | intraoperative |
| Quality of Recovery-15 (QoR-15) score | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Conventional intraoperative analgesia | Procedure | Intraoperative analgesia is performed by controlling the effect-site concentration of remifentanil at the discretion of attending anesthesiologists based on hemodynamic parameters. |
|
| at postoperative 24 hour |
| the incidence of postoperative nausea and vomiting | the incidence of postoperative nausea and vomiting is recorded by an investigator | at postoperative 1 hour, 24 hour, 72 hour |
| 11-pointed NRS pain score | 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. | at postoperative 24 hour |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |