Postoperative Bowel Function RecoveryNCT05122078
Effects of Analgesia Nociception Index (ANI)-Guided Analgesia on Postoperative Bowel Function.
A study testing ANI in people with Postoperative Bowel Function Recovery, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Postoperative Bowel Function Recovery
- What is being tested?
- ANI
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Nov 2021to 14 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 19 years who undergo laparoscopic colorectal surgery for colorectal cancer at Gangnam Severance Hospital, Seoul, South Korea.
Who cannot join
- 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)
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- Patients with chronic opioid medication.
- Cognitive impairment
- Unable to read consent form (eg illiterate, foreigner, etc.)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
GangnamSeverance Hospital
Seoul
Myung IL Bae, 82-2-2019-3520, BMI87@yuhs.ac
About this study
Official title: Effects of Analgesia Nociception Index (ANI)-Guided Analgesia on Postoperative Bowel Function Recovery in Laparoscopic Colorectal Surgery: A Prospective Randomized-controlled Study
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.
- Conditions
- Postoperative Bowel Function Recovery
- Being tested
- ANI, Control
- Keywords
- Analgesia Nociception Index (ANI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANIDevice
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.
ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ANI group | Experimental | 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. Receives: Device: ANI; Other: Control |
| Control group | No 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. We will not monitor ANI in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first gas passing from surgery
Time (hours) to first gas passing from surgery
Measured: Up to postoperative 2weeks
Secondary outcomes (12)
Time to starting fluid intake from surgery
Time (hours) to starting oral fluid intake after surgery
Measured: up to 2weeks
Time to starting soft diet from surgery
Time (hours) to starting soft diet from surgery
Measured: up to 2 weeks
Intraoperative opioid consumption
Total opioid dose administered to the patient during anesthesia
Measured: during anesthesia
Postoperative opioid consumption
Total opioid dose administered to the patient after surgery.
Measured: postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days.(Minimum value: 0, Maximum value: 10, higher score means worse.)
Pain score
Visual analog scale (VAS) 0-10
Measured: postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days.(Minimum value: 0, Maximum value: 10, higher score means worse.)
Nausea score
verbal numerical rating scale 0-10
Measured: postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days
Time to first rescue analgesics from surgery
Time (hours) to first rescue analgesics from surgery.
Measured: up to 2weeks
Number of vomiting, antiemetic administration
Number of vomiting, antiemetic administration
Measured: up to 2weeks
Time to starting ambulation from surgery.
Time (hours) to starting ambulation from surgery
Measured: up to 2 weeks
QoR-15
Score of QoR-15 questionnaire (Quality of Recovery-15) (Minimum value: 0, Maximum value: 150, higher score means better.)
Measured: postoperative 1days, 4days
Hemodynamics during anesthesia
hemodynamics (blood pressure, heart rate) during anesthesia
Measured: during anesthesia
Plasma concentration of Cortisol, Norepinephrine, Epinephrine, IL-6
Plasma concentration of Cortisol(mcg/dL), Norepinephrine(pg/mL), Epinephrine(pg/mL), IL-6(pg/mL) immediately after surgery
Measured: immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start29 Nov 2021
- Primary completion14 Oct 2025 (estimated)
- Study completion14 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Bowel Function RecoveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blinded randomized controlled study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Song, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122078
- Sponsor's protocol ID
- 3-2021-0348
- Status last verified
- Sep 2024
- First submitted
- 4 Nov 2021
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Analgesia Nociception Index (ANI)-Guided Analgesia on Postoperative Bowel Function Recovery in Laparoscopic Colorectal Surgery: A Prospective Randomized-controlled Study
- ClinicalTrials.gov ID
- NCT05122078
- Acronym / sponsor ID
- 3-2021-0348
- Conditions
- Postoperative Bowel Function Recovery
- Keywords
- Analgesia Nociception Index (ANI)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 14 Oct 2025 (estimated)
- Study completion
- 14 Oct 2025 (estimated)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single blinded randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| ANI group | Experimental | Device: ANI, Other: ControlInvestigator 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 group | No 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. We will not monitor ANI in this group. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 19 years who undergo laparoscopic colorectal surgery for colorectal cancer at Gangnam Severance Hospital, Seoul, South Korea.
Key exclusion criteria (9 listed)
- Emergency surgery
- Patients with history of open abdominal surgery
- Patients with arrhythmia
- Patients with pacemaker insertion
- Patients with history of heart transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANIInvestigators 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. | Device | ANI group |
| ControlRemifentanil 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. | Other | ANI group |
Primary outcome
Time to first gas passing from surgery
Time frame: Up to postoperative 2weeks
Time (hours) to first gas passing from surgery
12 secondary outcomes
Time to starting fluid intake from surgery
Time frame: up to 2weeks
Time to starting soft diet from surgery
Time frame: up to 2 weeks
Intraoperative opioid consumption
Time frame: during anesthesia
Postoperative opioid consumption
Time frame: postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days.(Minimum value: 0, Maximum value: 10, higher score means worse.)
Pain score
Time frame: postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days.(Minimum value: 0, Maximum value: 10, higher score means worse.)
Nausea score
Time frame: postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days
Time to first rescue analgesics from surgery
Time frame: up to 2weeks
Number of vomiting, antiemetic administration
Time frame: up to 2weeks
Time to starting ambulation from surgery.
Time frame: up to 2 weeks
QoR-15
Time frame: postoperative 1days, 4days
Hemodynamics during anesthesia
Time frame: during anesthesia
Plasma concentration of Cortisol, Norepinephrine, Epinephrine, IL-6
Time frame: immediately after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ANI in people with Postoperative Bowel Function Recovery, run by Gangnam Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Young Song (82-2-2019-3520, NEARMYHEART@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first gas passing from surgery (time frame: Up to postoperative 2weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.