Postoperative PainNCT04877574
ANI-guided Intraoperative Analgesia vs Conventional Intraoperative Analgesia
A study testing ANI-guided intraoperative analgesia and Conventional intraoperative analgesia in people with Postoperative Pain and Analgesia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study evaluates the effects of Analgesia Nociception Index (ANI)-guided intraoperative analgesia on postoperative pain in patients undergoing open gynecologic surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain, Analgesia, Surgery
- What is being tested?
- ANI-guided intraoperative analgesia and Conventional intraoperative analgesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2021to 15 Jul 2022
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Elective open gynecological surgery
- American Society of Anaesthesiologists physical status classification 1-3
Who cannot join
- Laparoscopic surgery or robot-assisted surgery
- Patients who had analgesic agents, anti-psychotic agents, anticonvulsants which were related to chronic pain
- Patients who had hypersensitivity to analgesic agents or medications related anesthesia.
- Patients who were required to have mechanical ventilation after surgery
- Patients who had arrhythmia
- Patients who transferred to the surgical intensive care unit immediately after surgery
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Analgesia Nociception Index (ANI)-Guided Intraoperative Analgesia on Postoperative Pain: a Randomized Controlled Study
This study evaluates the effects of Analgesia Nociception Index (ANI)-guided intraoperative analgesia on postoperative pain in patients undergoing open gynecologic surgery.
Read the detailed description
Postoperative pain is one of the most common postoperative complications and is significantly associated with patient's quality of recovery. Analgesia Nociception Index (ANI) is known to analyze the high frequency component of heart rate variability in relation to respiratory frequency, providing the objective information on the degree of pain. However, most previous studies conducted by using ANI were observational studies or small-sized randomized controlled studies. In the present study, the investigators aimed to evaluate the effects of ANI-guided intraoperative analgesia on moderate-to-severe postoperative pain by performing randomized controlled study.
- Conditions
- Postoperative Pain, Analgesia, Surgery
- Being tested
- ANI-guided intraoperative analgesia, Conventional intraoperative analgesia
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANI-guided intraoperative analgesiaProcedure or surgery
Intraoperative analgesia is performed by controlling the effect-site concentration of remifentanil to maintain 50-70 of ANI.
Conventional intraoperative analgesiaProcedure or surgery
Intraoperative analgesia is performed by controlling the effect-site concentration of remifentanil at the discretion of attending anesthesiologists based on hemodynamic parameters.
| Study group | Role | What they receive |
|---|---|---|
| ANI-guided intraoperative analgesia | Experimental | Intraoperative analgesia is performed by controlling the effect-site concentration of remifentanil to maintain 50-70 of ANI index. Receives: Procedure: ANI-guided intraoperative analgesia |
| Conventional intraoperative analgesia | Active comparator | Intraoperative analgesia is performed by controlling the effect-site concentration of remifentanil at the discretion of attending anesthesiologists based on hemodynamic parameters. Receives: Procedure: Conventional intraoperative analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of moderate-to-severe postoperative pain
the incidence of moderate-to-severe postoperative pain is defined as a case in which pain with numeric rating scale (NRS) of 5 or more is reported during stays in the postanesthesia care unit. Pain assessment is performed two times during stays in the postanesthesia care unit.
Measured: during 1 hour of stay in the postanesthesia care unit
Secondary outcomes (4)
the amount of intraoperative remifentanil
the amount of intraoperative remifentanil used during anesthesia
Measured: intraoperative
Quality of Recovery-15 (QoR-15) score
QoR-15 questionnaire is recorded by an investigator. QoR-15 questionnaire has minimum score of 0 and maximum score of 150, and higher score indicates the better quality of recovery.
Measured: at postoperative 24 hour
the incidence of postoperative nausea and vomiting
the incidence of postoperative nausea and vomiting is recorded by an investigator
Measured: at postoperative 1 hour, 24 hour, 72 hour
11-pointed NRS pain score
11-pointed NRS pain score is measured at both resting state and movement. 11-pointed NRS pain score has minimum score of 0 and maximum score of 10, and higher score indicates the higher severity of pain.
Measured: at postoperative 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start1 Jul 2021
- Primary completion11 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Soo Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877574
- Sponsor's protocol ID
- 2104-033-1209
- Status last verified
- Sep 2022
- First submitted
- 30 Apr 2021
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Analgesia Nociception Index (ANI)-Guided Intraoperative Analgesia on Postoperative Pain: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04877574
- Acronym / sponsor ID
- 2104-033-1209
- Conditions
- Postoperative Pain, Analgesia, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 11 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 7 May 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.
This study evaluates the effects of Analgesia Nociception Index (ANI)-guided intraoperative analgesia on postoperative pain in patients undergoing open gynecologic surgery.
Detailed description
Postoperative pain is one of the most common postoperative complications and is significantly associated with patient's quality of recovery. Analgesia Nociception Index (ANI) is known to analyze the high frequency component of heart rate variability in relation to respiratory frequency, providing the objective information on the degree of pain. However, most previous studies conducted by using ANI were observational studies or small-sized randomized controlled studies. In the present study, the investigators aimed to evaluate the effects of ANI-guided intraoperative analgesia on moderate-to-severe postoperative pain by performing randomized controlled study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ANI-guided intraoperative analgesia | Experimental | Procedure: ANI-guided intraoperative analgesiaIntraoperative analgesia is performed by controlling the effect-site concentration of remifentanil to maintain 50-70 of ANI index. |
| Conventional intraoperative analgesia | Active comparator | Procedure: Conventional intraoperative analgesiaIntraoperative analgesia is performed by controlling the effect-site concentration of remifentanil at the discretion of attending anesthesiologists based on hemodynamic parameters. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18
- Elective open gynecological surgery
- American Society of Anaesthesiologists physical status classification 1-3
Key exclusion criteria (7 listed)
- Laparoscopic surgery or robot-assisted surgery
- Patients who had analgesic agents, anti-psychotic agents, anticonvulsants which were related to chronic pain
- Patients who had hypersensitivity to analgesic agents or medications related anesthesia.
- Patients who were required to have mechanical ventilation after surgery
- Patients who had arrhythmia
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 |
|---|---|---|
| ANI-guided intraoperative analgesiaIntraoperative analgesia is performed by controlling the effect-site concentration of remifentanil to maintain 50-70 of ANI. | Procedure or surgery | ANI-guided intraoperative analgesia |
| Conventional intraoperative analgesiaIntraoperative analgesia is performed by controlling the effect-site concentration of remifentanil at the discretion of attending anesthesiologists based on hemodynamic parameters. | Procedure or surgery | Conventional intraoperative analgesia |
Primary outcome
the incidence of moderate-to-severe postoperative pain
Time frame: during 1 hour of stay in the postanesthesia care unit
the incidence of moderate-to-severe postoperative pain is defined as a case in which pain with numeric rating scale (NRS) of 5 or more is reported during stays in the postanesthesia care unit. Pain assessment is performed two times during stays in the postanesthesia care unit.
4 secondary outcomes
the amount of intraoperative remifentanil
Time frame: intraoperative
Quality of Recovery-15 (QoR-15) score
Time frame: at postoperative 24 hour
the incidence of postoperative nausea and vomiting
Time frame: at postoperative 1 hour, 24 hour, 72 hour
11-pointed NRS pain score
Time frame: at postoperative 24 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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-guided intraoperative analgesia and Conventional intraoperative analgesia in people with Postoperative Pain and Analgesia, run by Seoul National University 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 19 Sep 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of moderate-to-severe postoperative pain (time frame: during 1 hour of stay in the postanesthesia care unit). 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 19 Sep 2022.