Postoperative Bowel Function Recovery
Conditions
Keywords
Analgesia Nociception Index (ANI)
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.
Interventions
DEVICEANI
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.
OTHERControl
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.
Sponsors
Gangnam Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Patients don't know which group they belong to.
Intervention model description
Single blinded randomized controlled study
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first gas passing from surgery | Up to postoperative 2weeks | Time (hours) to first gas passing from surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to starting soft diet from surgery | up to 2 weeks | Time (hours) to starting soft diet from surgery |
| Intraoperative opioid consumption | during anesthesia | Total opioid dose administered to the patient during anesthesia |
| Postoperative opioid consumption | 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. |
| Pain score | 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 |
| Nausea score | postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days | verbal numerical rating scale 0-10 |
| Time to starting fluid intake from surgery | up to 2weeks | Time (hours) to starting oral fluid intake after surgery |
| Number of vomiting, antiemetic administration | up to 2weeks | Number of vomiting, antiemetic administration |
| Time to starting ambulation from surgery. | up to 2 weeks | Time (hours) to starting ambulation from surgery |
| QoR-15 | postoperative 1days, 4days | Score of QoR-15 questionnaire (Quality of Recovery-15) (Minimum value: 0, Maximum value: 150, higher score means better.) |
| Hemodynamics during anesthesia | during anesthesia | hemodynamics (blood pressure, heart rate) during anesthesia |
| Plasma concentration of Cortisol, Norepinephrine, Epinephrine, IL-6 | immediately after surgery | Plasma concentration of Cortisol(mcg/dL), Norepinephrine(pg/mL), Epinephrine(pg/mL), IL-6(pg/mL) immediately after surgery |
| Time to first rescue analgesics from surgery | up to 2weeks | Time (hours) to first rescue analgesics from surgery. |
Countries
South Korea
Contacts
Primary ContactYoung Song
Backup ContactMyung IL Bae
Outcome results
None listed