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NCT Number: NCT05122078

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

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.

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Key information

Conditions

Postoperative Bowel Function Recovery

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

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.

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.

Primary outcomes

  1. Time to first gas passing from surgery

    Time frame: Up to postoperative 2weeks

    Time (hours) to first gas passing from surgery

Secondary outcomes

  1. Time to starting fluid intake from surgery

    Time frame: up to 2weeks

    Time (hours) to starting oral fluid intake after surgery

  2. Time to starting soft diet from surgery

    Time frame: up to 2 weeks

    Time (hours) to starting soft diet from surgery

  3. Intraoperative opioid consumption

    Time frame: during anesthesia

    Total opioid dose administered to the patient during anesthesia

  4. Postoperative opioid consumption

    Time frame: 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.

  5. Pain score

    Time frame: 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

  6. Nausea score

    Time frame: postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days

    verbal numerical rating scale 0-10

  7. Time to first rescue analgesics from surgery

    Time frame: up to 2weeks

    Time (hours) to first rescue analgesics from surgery.

  8. Number of vomiting, antiemetic administration

    Time frame: up to 2weeks

    Number of vomiting, antiemetic administration

  9. Time to starting ambulation from surgery.

    Time frame: up to 2 weeks

    Time (hours) to starting ambulation from surgery

  10. QoR-15

    Time frame: postoperative 1days, 4days

    Score of QoR-15 questionnaire (Quality of Recovery-15) (Minimum value: 0, Maximum value: 150, higher score means better.)

  11. Hemodynamics during anesthesia

    Time frame: during anesthesia

    hemodynamics (blood pressure, heart rate) during anesthesia

  12. Plasma concentration of Cortisol, Norepinephrine, Epinephrine, IL-6

    Time frame: immediately after surgery

    Plasma concentration of Cortisol(mcg/dL), Norepinephrine(pg/mL), Epinephrine(pg/mL), IL-6(pg/mL) immediately after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Myung IL Bae

CONTACT

[email protected]

82-2-2019-3520

Young Song

CONTACT

[email protected]

82-2-2019-3520

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Nov 16, 2021
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.