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

NCT05122078 | Recruiting DMC

• 1 other identifier: 3-2021-0348
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Bowel Function Recovery

Keywords

Analgesia Nociception Index (ANI)

Outcome Measures

Primary Outcomes (1)

• Time to first gas passing from surgery

  Time (hours) to first gas passing from surgery

  Up to postoperative 2weeks

Secondary Outcomes (12)

• Time to starting fluid intake from surgery

  up to 2weeks

• Time to starting soft diet from surgery

  up to 2 weeks

• Intraoperative opioid consumption

  during anesthesia

• Postoperative opioid consumption

  postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days.(Minimum value: 0, Maximum value: 10, higher score means worse.)

• Pain score

  postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days.(Minimum value: 0, Maximum value: 10, higher score means worse.)

Study Arms (2)

ANI group

EXPERIMENTAL

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; Other: Control

Control group

NO INTERVENTION

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.

Interventions

ANI DEVICE

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.

ANI group

Control OTHER

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.

ANI group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

GangnamSeverance Hospital

Seoul, South Korea

RECRUITING

Central Study Contacts

Young Song

CONTACT

82-2-2019-3520; NEARMYHEART@yuhs.ac

Myung IL Bae

CONTACT

82-2-2019-3520; BMI87@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients don't know which group they belong to.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Single blinded randomized controlled study

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: November 16, 2021
• Study Start: November 29, 2021
• Primary Completion: October 14, 2025
• Study Completion: October 14, 2025
• Last Updated: September 5, 2024

Record last verified: 2024-09

Locations

KR (1)