Effects of Analgesia Nociception Index (ANI)-Guided Analgesia on Postoperative Bowel Function.

Not Applicable

Recruiting

• Conditions: Postoperative Bowel Function Recovery
• Interventions: Device: ANI; Other: Control

• Registration Number: NCT05122078
• Lead Sponsor: Gangnam Severance Hospital

Brief Summary

Investigators will examaine the effects of Analgesia Nociception Index (ANI)-guided analgesia on postoperative bowel function recovery in laparoscopic colorectal surgery. This is a prospective randomized-controlled study.

Investigators will randomly divide the patients into two groups. In ANI group, remifentanil infusion rate during anesthesia will be adjusted according to ANI monitoring. In Control group, remifentanil infusion rate during anesthesia will be adjusted according to the conventional method of blood pressure and heart rate monitroing. And Investigators will evalualte the bowel function recovery in both groups after surgery, and compare between the two groups.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-04
• Study First Submitted QC: 2021-11-04
• Study First Posted: 2021-11-16
• Study Start: 2021-11-29
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18
• Primary Completion: 2025-10-14
• Study Completion: 2025-10-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients over 19 years who undergo laparoscopic colorectal surgery for colorectal cancer at Gangnam Severance Hospital, Seoul, South Korea.

Exclusion Criteria

• Emergency surgery
• Patients undergoing colostomy
• Patients with history of open abdominal surgery
• Patients with arrhythmia
• Patients with pacemaker insertion
• Patients with history of heart transplantation
• Patients taking medications that may affect ANI (antimuscarinics, alpha-agonists, beta blockers)
• Patients with chronic opioid medication.
• Cognitive impairment
• Unable to read consent form (eg illiterate, foreigner, etc.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ANI group	Control	Investigator will attach the ANI monitor V2 (MDoloris Medical Systems, Lille, France) to the patient and monitor Analgesia Nociception Index (ANI) during anesthesia. Remifentanil infusion rate is adjusted according to ANI monitoring. The ANI is adjusted to be between 50 and 70.
ANI group	ANI	Investigator will attach the ANI monitor V2 (MDoloris Medical Systems, Lille, France) to the patient and monitor Analgesia Nociception Index (ANI) during anesthesia. Remifentanil infusion rate is adjusted according to ANI monitoring. The ANI is adjusted to be between 50 and 70.

Primary Outcome Measures

Name	Time	Method
Time to first gas passing from surgery	Up to postoperative 2weeks	Time (hours) to first gas passing from surgery

Secondary Outcome Measures

Name	Time	Method
Postoperative opioid consumption	postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days.(Minimum value: 0, Maximum value: 10, higher score means worse.)	Total opioid dose administered to the patient after surgery.
Time to starting fluid intake from surgery	up to 2weeks	Time (hours) to starting oral fluid intake after surgery
Time to first rescue analgesics from surgery	up to 2weeks	Time (hours) to first rescue analgesics from surgery.
Time to starting soft diet from surgery	up to 2 weeks	Time (hours) to starting soft diet from surgery
Nausea score	postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days	verbal numerical rating scale 0-10
Number of vomiting, antiemetic administration	up to 2weeks	Number of vomiting, antiemetic administration
Time to starting ambulation from surgery.	up to 2 weeks	Time (hours) to starting ambulation from surgery
QoR-15	postoperative 1days, 4days	Score of QoR-15 questionnaire (Quality of Recovery-15) (Minimum value: 0, Maximum value: 150, higher score means better.)
Plasma concentration of Cortisol, Norepinephrine, Epinephrine, IL-6	immediately after surgery	Plasma concentration of Cortisol(mcg/dL), Norepinephrine(pg/mL), Epinephrine(pg/mL), IL-6(pg/mL) immediately after surgery
Intraoperative opioid consumption	during anesthesia	Total opioid dose administered to the patient during anesthesia
Pain score	postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days.(Minimum value: 0, Maximum value: 10, higher score means worse.)	Visual analog scale (VAS) 0-10
Hemodynamics during anesthesia	during anesthesia	hemodynamics (blood pressure, heart rate) during anesthesia

Trial Locations

Locations (1)

GangnamSeverance Hospital; 🇰🇷 Seoul, Korea, Republic of