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

NCT ID: NCT05122078

Last Updated: 2024-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-29

Study Completion Date

2025-10-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Bowel Function Recovery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single blinded randomized controlled study
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Patients don't know which group they belong to.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ANI group

Investigator 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.

Group Type EXPERIMENTAL

ANI

Intervention Type 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

Intervention Type 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.

Control group

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. We will not monitor ANI in this group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ANI

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.

Intervention Type DEVICE

Control

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.)
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gangnam Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Young Song

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GangnamSeverance Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Young Song

Role: CONTACT

82-2-2019-3520

Myung IL Bae

Role: CONTACT

82-2-2019-3520

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Myung IL Bae

Role: primary

82-2-2019-3520

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

3-2021-0348

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mechanical Bowel Prep Randomized Study
NCT04931173 NOT_YET_RECRUITING NA