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

Yonsei University Health System (YUHS)

Status: Enrolling

Conditions: Postoperative Bowel Function Recovery

Treatments: Other: Control; Device: ANI

Study type: Interventional

Funder types: Other

Identifiers

NCT05122078

3-2021-0348

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

ANI group

Experimental group

Description:

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.

Treatment:

Device: ANI

Other: Control

Control group

No Intervention group

Description:

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.