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

Effects of Analgesia Nociception Index (ANI)-Guided Analgesia on Postoperative Bowel Function Recovery in Laparoscopic Colorectal Surgery: A Prospective Randomized-controlled Study

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Bowel Function Recovery
• Intervention / Treatment: Device: ANI; Other: Control

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Young Song; Phone Number: 82-2-2019-3520; Email: NEARMYHEART@yuhs.ac
• Study Contact Backup: Name: Myung IL Bae; Phone Number: 82-2-2019-3520; Email: BMI87@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • GangnamSeverance Hospital
    • Contact: Myung IL Bae; Phone Number: 82-2-2019-3520; Email: BMI87@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ANI group; 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.	Device: ANI; Investigators 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.; Other: Control; Remifentanil infusion rate is adjusted according to the conventional method of blood pressure and heart rate monitroing. Blood pressure and heart rate are controlled to be within 20% of baseline. Investigators will not monitor ANI in this group.
No Intervention: Control group; Remifentanil infusion rate is adjusted according to the conventional method of blood pressure and heart rate monitroing. Blood pressure and heart rate are controlled to be within 20% of baseline. We will not monitor ANI in this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first gas passing from surgery	Time (hours) to first gas passing from surgery	Up to postoperative 2weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2021
• Primary Completion (Estimated): October 14, 2025
• Study Completion (Estimated): October 14, 2025

Study Registration Dates

• First Submitted: November 4, 2021
• First Submitted That Met QC Criteria: November 4, 2021
• First Posted (Actual): November 16, 2021

Study Record Updates

• Last Update Posted (Estimated): September 5, 2024
• Last Update Submitted That Met QC Criteria: September 2, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Analgesia Nociception Index (ANI)
• Other Study ID Numbers: 3-2021-0348

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No