Effect of Nociception Level Monitoring During Remimazolam-based Total Intravenous Anesthesia on Intraoperative Opioid Requirements and Postoperative Pain
June 21, 2026 updated by: Yonsei University
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 Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, South Korea
- Yonsei University Health System, Severance Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Adult patients between 19 and 64 years of age, ASA class I~III, scheduled for arthroscopic knee surgeryunder general anesthesia.
Exclusion Criteria:
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: ANI-guided
Patients receiving remimazolam-based total intravenous general anesthesia with nociception monitoring with the ANI monitor
|
Patients will receive remimazolam-based total intravenous general anesthesia with nociception monitoring with the ANI monitor
|
|
Experimental: Standard
Patients receiving remimazolam-based total intravenous general anesthesia based on hemodynamic variables and without ANI nociception monitoring
|
Patients will receive remimazolam-based total intravenous general anesthesia based on hemodynamic monitoring and without nociception monitoring
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intraoperative remifentanil requirement
Time Frame: Within the intraoperative period
|
Intraoperative remifentanil requirements will be collected as primary outcome as µg/kg/min
|
Within the intraoperative period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Seokyung Shin, Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 17, 2023
Primary Completion (Actual)
November 21, 2025
Study Completion (Actual)
November 21, 2025
Study Registration Dates
First Submitted
November 7, 2022
First Submitted That Met QC Criteria
November 7, 2022
First Posted (Actual)
November 14, 2022
Study Record Updates
Last Update Posted (Actual)
June 23, 2026
Last Update Submitted That Met QC Criteria
June 21, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2022-1155
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.