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Clinical Trials/NCT05122078
NCT05122078
Recruiting
Not Applicable

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

Gangnam Severance Hospital1 site in 1 country80 target enrollmentNovember 29, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Bowel Function Recovery
Sponsor
Gangnam Severance Hospital
Enrollment
80
Locations
1
Primary Endpoint
Time to first gas passing from surgery
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 29, 2021
End Date
October 14, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Young Song

Associate Professor

Gangnam Severance Hospital

Eligibility Criteria

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.)

Outcomes

Primary Outcomes

Time to first gas passing from surgery

Time Frame: Up to postoperative 2weeks

Time (hours) to first gas passing from surgery

Secondary Outcomes

  • Postoperative opioid consumption(postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days.(Minimum value: 0, Maximum value: 10, higher score means worse.))
  • Time to starting fluid intake from surgery(up to 2weeks)
  • Time to first rescue analgesics from surgery(up to 2weeks)
  • Time to starting soft diet from surgery(up to 2 weeks)
  • Nausea score(postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days)
  • Number of vomiting, antiemetic administration(up to 2weeks)
  • Time to starting ambulation from surgery.(up to 2 weeks)
  • QoR-15(postoperative 1days, 4days)
  • Plasma concentration of Cortisol, Norepinephrine, Epinephrine, IL-6(immediately after surgery)
  • Intraoperative opioid consumption(during anesthesia)
  • Pain score(postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days.(Minimum value: 0, Maximum value: 10, higher score means worse.))
  • Hemodynamics during anesthesia(during anesthesia)

Study Sites (1)

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