ANI-guided Intraoperative Analgesia vs Conventional Intraoperative Analgesia

Surgery Clinical Trial

Official title:

Effects of Analgesia Nociception Index (ANI)-Guided Intraoperative Analgesia on Postoperative Pain: a Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04877574
• Other study ID #: 2104-033-1209
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: July 15, 2022

Study information

• Verified date: September 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: July 15, 2022
• Est. primary completion date: July 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Pain, Postoperative
• Postoperative Pain
• Surgery

Intervention

Procedure:
• ANI-guided intraoperative analgesia
Intraoperative analgesia is performed by controlling the effect-site concentration of remifentanil to maintain 50-70 of ANI.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	the amount of intraoperative remifentanil	the amount of intraoperative remifentanil used during anesthesia	intraoperative
Secondary	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.	at postoperative 24 hour
Secondary	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
Secondary	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