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

Not Applicable

Recruiting

• Conditions: Adult Patients Aged 19-64, Scheduled for Elective Arthroscopic Knee Surgery
• Interventions: Device: Analgesia Nociception Index monitor; Device: Standard monitoring

• Registration Number: NCT05615441
• Lead Sponsor: Yonsei University

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-11
• Study Start: 2022-11-02
• Study First Submitted: 2022-11-07
• Study First Submitted QC: 2022-11-07
• Last Update Submitted: 2022-11-07
• Study First Posted: 2022-11-14
• Last Update Posted: 2022-11-14
• Primary Completion: 2024-11-01
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ANI-guided	Analgesia Nociception Index monitor	Patients receiving remimazolam-based total intravenous general anesthesia with nociception monitoring with the ANI monitor
Standard	Standard monitoring	Patients receiving remimazolam-based total intravenous general anesthesia based on hemodynamic variables and without ANI nociception monitoring

Primary Outcome Measures

Name	Time	Method
Intraoperative remifentanil requirement	Within the intraoperative period	Intraoperative remifentanil requirements will be collected as primary outcome as µg/kg/min

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of