Effect of Nociception Level Monitoring During Remimazolam-based Total Intravenous Anesthesia on Intraoperative Opioid Requirements and Postoperative Pain

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Nociception Level Monitoring During Remimazolam-based Total Intravenous Anesthesia on Intraoperative Opioid Requirements and Postoperative Pain

Conditions
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Adult Patients Aged 19-64, Scheduled for Elective Arthroscopic Knee Surgery

Intervention / Treatment
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* Device: Analgesia Nociception Index monitor
* Device: Standard monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ANI-guided<br>Patients receiving remimazolam-based total intravenous general anesthesia with nociception monitoring with the ANI monitor | Device: Analgesia Nociception Index monitor<br>* Patients will receive remimazolam-based total intravenous general anesthesia with nociception monitoring with the ANI monitor<br>|
| Experimental: Standard<br>Patients receiving remimazolam-based total intravenous general anesthesia based on hemodynamic variables and without ANI nociception monitoring | Device: Standard monitoring<br>* Patients will receive remimazolam-based total intravenous general anesthesia based on hemodynamic monitoring and without nociception monitoring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative remifentanil requirement | Intraoperative remifentanil requirements will be collected as primary outcome as µg/kg/min | Within the intraoperative period |