Pain MeasurementNCT06432894
Performance Evaluation of ANI in Patients Under General Anesthesia With Remimazolam
An observational study of Pain Measurement, run by Catholic Kwandong University at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether Analgesia Nociception Index (ANI) can effectively reduce the dose of opioid in patients who underwent general anesthesia using remimazolam. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Pain Measurement
- What is being tested?
- Analgesia Nociception Index, remimazolam
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Apr 2024to 11 Jun 2025
- How long will I take part?
- 20 Months
- Phase
- Observational
- 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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who visit the hospital and undergo surgery
Who may be able to join
- Patients
- aged 20-79 years under general anaesthesia with remimazolam
- scheduled to undergo robotic surgery
- in American Society of Anesthesiologists physical class 1, 2 or 3
- voluntarily agree in writing to participate in this clinical study
Who cannot join
- Conditions affecting the autonomic nervous system
- other conditions or disease that may cause acute or chronic pain
- the NRS before induction of anesthesia is 1 or over
- When taking medications that may affect the autonomic nervous system
- In other cases where the investigator deems the subject unsuitable for this trial
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Catholic-Kwandong University, School of Medicine
Incheon, 22711
Jungmin Lee, MD, 821041929159, jminyi19@gmail.com
Joohyun Lee, MD, 821074200912, hightothesky1004@gmail.com
About this study
Official title: Performance Evaluation of Analgesia Nociception Index (ANI) in Patients Under General Anaesthesia With Remimazolam: a Prospective Observational Study
The purpose of this study is to determine whether Analgesia Nociception Index (ANI) can effectively reduce the dose of opioid in patients who underwent general anesthesia using remimazolam.
- Conditions
- Pain Measurement
- Being tested
- Analgesia Nociception Index, remimazolam
- Keywords
- Remimazolam, Remifentanil, Analgesia Nociception Index (ANI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analgesia Nociception Index, remimazolamCombination product
The purpose of this study is to determine the validity of ANI in patients undergoing surgery with remifentanil and remimazolam.
During this study, remimazolam infusion rate is determined by the pharmacopoeia.
Remifentanil infusion rate is determined based on the patient's vital signs, systemic status and pain levels. And remifentanil is administrated via targeted infusion control using the Minto model.
ANI scores, vital signs, remifentanil infusion rate are collected at predetermined time points according to the protocol from the start to the end of the surgery.
| Study group | Role | What they receive |
|---|---|---|
| observation | Patients
* aged 20-80 years under general anaesthesia with remimazolam
* scheduled to undergo robotic surgery
* in American Society of Anesthesiologists physical class 1, 2 or 3 Receives: Combination Product: Analgesia Nociception Index, remimazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
ANI values
A value indicating the degree of pain calculated by ANI's algorithm
Measured: During Surgery (at the points of intubation, skin incision, CO2 insufflation, TOF stimulation, and hemodynamic change)
Secondary outcomes (5)
Heart Rate (HR) change
Because the ANI value is calculated using the change in HR, it is measured to correlate the change in ANI value with the change in HR due to pain.
Measured: Every 2 seconds for 2.5 minutes before and Every 2 seconds for 2.5 minutes after pain stimulation
Patient state index (PSI) change
The PSI is an indicator of a patient's depth of sedation and is calculated based on EEG, which can change in response to painful stimuli. The PSI score is expressed as a number between 0 and 100, and it is usually recommended to maintain under 60 during surgery. An increase in the PSI score can indicates the degree of pain stimulus and can be used as an indicator to assess the validity of the ANI value.
Measured: Every 2 seconds for 2.5 minutes before and Every 2 seconds for 2.5 minutes after pain stimulation
Blood Pressure change
When a patient feels pain, it stimulates the autonomic nervous system to change blood pressure. This change is measured to determine how much pain the patient is feeling
Measured: Every 2 seconds for 2.5 minutes before and Every 2 seconds for 2.5 minutes after pain stimulation
Remimazolam infusion rate
Remimazolam is a sedative. The infusion rate of remimazolam correlates with sedation level. And it is measured to determine if sedation level correlates with ANI values when pain stimuli are given.
Measured: During Surgery (at the points of intubation, skin incision, CO2 insufflation, TOF stimulation, and hemodynamic change)
Effect site concentration of remifentanil
Remifentanil is an opioid and can affect pain levels when given a pain stimulus.
Measured: During Surgery (at the points of intubation, skin incision, CO2 insufflation, TOF stimulation, and hemodynamic change)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start23 Apr 2024
- Primary completion11 Jun 2025 (estimated)
- Study completion11 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain MeasurementStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 20 Months
Sponsor and investigators
- Lead sponsor
- Catholic Kwandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jungmin Lee, Catholic Kwandong University
- Investigators
- Young Joo, Study chair, Ilsan Cha hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432894
- Sponsor's protocol ID
- Ilsan_Cha_2023-04-003-005
- Status last verified
- May 2024
- First submitted
- 17 May 2024
- Last updated
- 30 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation of Analgesia Nociception Index (ANI) in Patients Under General Anaesthesia With Remimazolam: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06432894
- Acronym / sponsor ID
- Ilsan_Cha_2023-04-003-005
- Conditions
- Pain Measurement
- Keywords
- Remimazolam, Remifentanil, Analgesia Nociception Index (ANI)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Catholic Kwandong UniversityUniversity, hospital or other
- Study start
- 23 Apr 2024 (actual)
- Primary completion
- 11 Jun 2025 (estimated)
- Study completion
- 11 Jun 2025 (estimated)
- First posted
- 29 May 2024 (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.
The purpose of this study is to determine whether Analgesia Nociception Index (ANI) can effectively reduce the dose of opioid in patients who underwent general anesthesia using remimazolam.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 20 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observation | – | Combination Product: Analgesia Nociception Index, remimazolamPatients * aged 20-80 years under general anaesthesia with remimazolam * scheduled to undergo robotic surgery * in American Society of Anesthesiologists physical class 1, 2 or 3 |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who visit the hospital and undergo surgery
Key inclusion criteria (5 listed)
- Patients
- aged 20-79 years under general anaesthesia with remimazolam
- scheduled to undergo robotic surgery
- in American Society of Anesthesiologists physical class 1, 2 or 3
- voluntarily agree in writing to participate in this clinical study
Key exclusion criteria (5 listed)
- Conditions affecting the autonomic nervous system
- other conditions or disease that may cause acute or chronic pain
- the NRS before induction of anesthesia is 1 or over
- When taking medications that may affect the autonomic nervous system
- In other cases where the investigator deems the subject unsuitable for this trial
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 |
|---|---|---|
| Analgesia Nociception Index, remimazolamThe purpose of this study is to determine the validity of ANI in patients undergoing surgery with remifentanil and remimazolam. During this study, remimazolam infusion rate is determined by the pharmacopoeia. Remifentanil infusion rate is determined based on the patient's vital signs, systemic status and pain levels. And remifentanil is administrated via targeted infusion control using the Minto model. ANI scores, vital signs, remifentanil infusion rate are collected at predetermined time points according to the protocol from the start to the end of the surgery. | Combination product | observation |
Primary outcome
ANI values
Time frame: During Surgery (at the points of intubation, skin incision, CO2 insufflation, TOF stimulation, and hemodynamic change)
A value indicating the degree of pain calculated by ANI's algorithm
5 secondary outcomes
Heart Rate (HR) change
Time frame: Every 2 seconds for 2.5 minutes before and Every 2 seconds for 2.5 minutes after pain stimulation
Patient state index (PSI) change
Time frame: Every 2 seconds for 2.5 minutes before and Every 2 seconds for 2.5 minutes after pain stimulation
Blood Pressure change
Time frame: Every 2 seconds for 2.5 minutes before and Every 2 seconds for 2.5 minutes after pain stimulation
Remimazolam infusion rate
Time frame: During Surgery (at the points of intubation, skin incision, CO2 insufflation, TOF stimulation, and hemodynamic change)
Effect site concentration of remifentanil
Time frame: During Surgery (at the points of intubation, skin incision, CO2 insufflation, TOF stimulation, and hemodynamic change)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Individual participant dataSharing planned: Yes
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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.
Young Joo study chair
Ilsan Cha hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain Measurement, run by Catholic Kwandong University 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 5 inclusion and 5 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 30 May 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 Jungmin Lee (821041929159, jminyi19@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ANI values (time frame: During Surgery (at the points of intubation, skin incision, CO2 insufflation, TOF stimulation, and hemodynamic change)). 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 30 May 2024.