Adult Patients Aged 19-64, Scheduled for Elective Arthroscopic Knee SurgeryNCT05615441
Effect of Nociception Level Monitoring During Remimazolam-based Total Intravenous Anesthesia on Intraoperative Opioid Requirements and Postoperative Pain
A study testing Analgesia Nociception Index monitor and Standard monitoring in people with Adult Patients Aged 19-64, Scheduled for Elective Arthroscopic Knee Surgery, run by Yonsei University at 1 site in South Korea.
Trial summary
This study aims to investigate whether the use of nociception monitoring during general anesthesia with remimazolam-based total intravenous anesthesia has an effect on intraoperative opioid requirements and postoperative pain. This study is a randomized trial with a 50% probability of being assigned to either group. Read more about this study
- Who is it for?
- Ages 19 to 64 years
- Conditions the study is for
- Adult Patients Aged 19-64, Scheduled for Elective Arthroscopic Knee Surgery
- What is being tested?
- Analgesia Nociception Index monitor and Standard monitoring
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Jul 2023to 21 Nov 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients between 19 and 64 years of age, ASA class I~III, scheduled for arthroscopic knee surgeryunder general anesthesia.
Who cannot join
- Patient refusal, patients unable to read consent form, active URI or uncontrolled asthma, pneumonia, history of allergies to benzodiazepines, decreased liver or kidney function, heart failure of ejection fraction<55%, pregnant or breastfeeding patients, history of substance abuse/addiction
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
About this study
This study aims to investigate whether the use of nociception monitoring during general anesthesia with remimazolam-based total intravenous anesthesia has an effect on intraoperative opioid requirements and postoperative pain. This study is a randomized trial with a 50% probability of being assigned to either group. Randomization will be done by an anesthesiologist not involved in anesthesia or postoperative outcome assessment. Patients and the investigator in charge of postoperative outcomes assessment will be blinded to group allocation.
- Being tested
- Analgesia Nociception Index monitor, Standard monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analgesia Nociception Index monitorDevice
Patients will receive remimazolam-based total intravenous general anesthesia with nociception monitoring with the ANI monitor
Standard monitoringDevice
Patients will receive remimazolam-based total intravenous general anesthesia based on hemodynamic monitoring and without nociception monitoring
| Study group | Role | What they receive |
|---|---|---|
| ANI-guided | Active comparator | Patients receiving remimazolam-based total intravenous general anesthesia with nociception monitoring with the ANI monitor Receives: Device: Analgesia Nociception Index monitor |
| Standard | Experimental | Patients receiving remimazolam-based total intravenous general anesthesia based on hemodynamic variables and without ANI nociception monitoring Receives: Device: Standard monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative remifentanil requirement
Intraoperative remifentanil requirements will be collected as primary outcome as µg/kg/min
Measured: Within the intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start17 Jul 2023
- Primary completion21 Nov 2025
- Study completion21 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Patients Aged 19-64, Scheduled for Elective Arthroscopic Knee SurgeryStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seokyung Shin, Principal investigator, Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615441
- Sponsor's protocol ID
- 4-2022-1155
- Status last verified
- Jun 2026
- First submitted
- 7 Nov 2022
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nociception Level Monitoring During Remimazolam-based Total Intravenous Anesthesia on Intraoperative Opioid Requirements and Postoperative Pain
- ClinicalTrials.gov ID
- NCT05615441
- Acronym / sponsor ID
- 4-2022-1155
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 21 Nov 2025 (actual)
- Study completion
- 21 Nov 2025 (actual)
- First posted
- 14 Nov 2022 (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 aims to investigate whether the use of nociception monitoring during general anesthesia with remimazolam-based total intravenous anesthesia has an effect on intraoperative opioid requirements and postoperative pain. This study is a randomized trial with a 50% probability of being assigned to either group. Randomization will be done by an anesthesiologist not involved in anesthesia or postoperative outcome assessment. Patients and the investigator in charge of postoperative outcomes assessment will be blinded to group allocation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ANI-guided | Active comparator | Device: Analgesia Nociception Index monitorPatients receiving remimazolam-based total intravenous general anesthesia with nociception monitoring with the ANI monitor |
| Standard | Experimental | Device: Standard monitoringPatients receiving remimazolam-based total intravenous general anesthesia based on hemodynamic variables and without ANI nociception monitoring |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult patients between 19 and 64 years of age, ASA class I~III, scheduled for arthroscopic knee surgeryunder general anesthesia.
Key exclusion criteria (1 listed)
- Patient refusal, patients unable to read consent form, active URI or uncontrolled asthma, pneumonia, history of allergies to benzodiazepines, decreased liver or kidney function, heart failure of ejection fraction<55%, pregnant or breastfeeding patients, history of substance abuse/addiction
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 monitorPatients will receive remimazolam-based total intravenous general anesthesia with nociception monitoring with the ANI monitor | Device | ANI-guided |
| Standard monitoringPatients will receive remimazolam-based total intravenous general anesthesia based on hemodynamic monitoring and without nociception monitoring | Device | Standard |
Primary outcome
Intraoperative remifentanil requirement
Time frame: Within the intraoperative period
Intraoperative remifentanil requirements will be collected as primary outcome as µg/kg/min
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 23 Jun 2026.
- Individual participant dataSharing planned: No
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.
Seokyung Shin principal investigator
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Analgesia Nociception Index monitor and Standard monitoring in people with Adult Patients Aged 19-64, Scheduled for Elective Arthroscopic Knee Surgery, run by Yonsei 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 1 inclusion and 1 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 23 Jun 2026. 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?
Intraoperative remifentanil requirement (time frame: Within the intraoperative period). 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 23 Jun 2026.