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

ConditionPostoperative Bowel Function Recovery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorGangnam Severance Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Patients over 19 years who undergo laparoscopic colorectal surgery for colorectal cancer at Gangnam Severance Hospital, Seoul, South Korea.

Disqualifiers

Emergency surgery

Patients with history of open abdominal surgery

Patients with arrhythmia

Patients with pacemaker insertion

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: ANI groupExperimental treatment 2 interventions
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Time to first gas passing from surgery

Time (hours) to first gas passing from surgery

Time frame
Up to postoperative 2weeks

Secondary outcomes

1

Time to starting fluid intake from surgery

Time (hours) to starting oral fluid intake after surgery

Time frame
up to 2weeks
2

Time to starting soft diet from surgery

Time (hours) to starting soft diet from surgery

Time frame
up to 2 weeks
3

Intraoperative opioid consumption

Total opioid dose administered to the patient during anesthesia

Time frame
during anesthesia
4

Postoperative opioid consumption

Total opioid dose administered to the patient after surgery.

Time frame
postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days.(Minimum value: 0, Maximum value: 10, higher score means worse.)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gangnam Severance Hospital

Lead sponsor

Source ClinicalTrials.gov
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