ANI-guided Intraoperative Analgesia vs Conventional Intraoperative Analgesia

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04877574
• Collaborator: (none)
• Enrollment: 170
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 13
• Patients Per Site Per Month: 13.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain; Analgesia; Surgery	Procedure: ANI-guided intraoperative analgesia; Procedure: Conventional intraoperative analgesia	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 170 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Effects of Analgesia Nociception Index (ANI)-Guided Intraoperative Analgesia on Postoperative Pain: a Randomized Controlled Study
• Anticipated Study Start Date: Jul 1, 2021
• Anticipated Primary Completion Date: Apr 30, 2022
• Anticipated Study Completion Date: Jul 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ANI-guided intraoperative analgesia Intraoperative analgesia is performed by controlling the effect-site concentration of remifentanil to maintain 50-70 of ANI index.	Procedure: ANI-guided intraoperative analgesia; Intraoperative analgesia is performed by controlling the effect-site concentration of remifentanil to maintain 50-70 of ANI.
Active Comparator: 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.	Procedure: 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.

Outcome Measures

Primary Outcome Measures

1. 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

1. the amount of intraoperative remifentanil [intraoperative]

   the amount of intraoperative remifentanil used during anesthesia

2. 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.

3. 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

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	03080

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hee-Soo Kim, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT04877574
• Other Study ID Numbers: 2104-033-1209
• First Posted: May 7, 2021
• Last Update Posted: Jul 1, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

No Results Posted as of Jul 1, 2021