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
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