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

Study Overview
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Brief Summary
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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.

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

Conditions
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Postoperative Bowel Function Recovery

Intervention / Treatment
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* Device: ANI
* Other: Control


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single blinded randomized controlled study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ANI group<br>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<br>* 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.<br>Other: Control<br>* 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.<br>|
| No Intervention: Control group<br>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?
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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 |
| --- | --- | --- |
| 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.) | 
| Nausea score | verbal numerical rating scale 0-10 | postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgesia Nociception Index (ANI)