Clinical trial NCT05122078: Effects of Analgesia Nociception Index (ANI)-Guided Analgesia on Postoperative Bowel Function.
Official title: Effects of Analgesia Nociception Index (ANI)-Guided Analgesia on Postoperative Bowel Function Recovery in Laparoscopic Colorectal Surgery: A Prospective Randomized-controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Bowel Function Recovery
Keywords: Analgesia Nociception Index (ANI)
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blinded randomized controlled study
Primary purpose: PREVENTION

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.


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 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.)

Primary outcomes:
measure: Time to first gas passing from surgery
timeFrame: Up to postoperative 2weeks
Secondary outcomes:
measure: Time to starting fluid intake from surgery
timeFrame: up to 2weeks
measure: Time to starting soft diet from surgery
timeFrame: up to 2 weeks
measure: Intraoperative opioid consumption
timeFrame: during anesthesia
measure: Postoperative opioid consumption
timeFrame: postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days.(Minimum value: 0, Maximum value: 10, higher score means worse.)
measure: Pain score
timeFrame: postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days.(Minimum value: 0, Maximum value: 10, higher score means worse.)
measure: Nausea score
timeFrame: postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days
measure: Time to first rescue analgesics from surgery
timeFrame: up to 2weeks
measure: Number of vomiting, antiemetic administration
timeFrame: up to 2weeks
measure: Time to starting ambulation from surgery.
timeFrame: up to 2 weeks
measure: QoR-15
timeFrame: postoperative 1days, 4days
measure: Hemodynamics during anesthesia
timeFrame: during anesthesia
measure: Plasma concentration of Cortisol, Norepinephrine, Epinephrine, IL-6
timeFrame: immediately after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GangnamSeverance Hospital
Study officials:
References: