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Clinical Trials/NCT05615441
NCT05615441
Recruiting
Not Applicable

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

Yonsei University1 site in 1 country58 target enrollmentNovember 2, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adult Patients Aged 19-64, Scheduled for Elective Arthroscopic Knee Surgery
Sponsor
Yonsei University
Enrollment
58
Locations
1
Primary Endpoint
Intraoperative remifentanil requirement
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2, 2022
End Date
November 1, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Intraoperative remifentanil requirement

Time Frame: Within the intraoperative period

Intraoperative remifentanil requirements will be collected as primary outcome as µg/kg/min

Study Sites (1)

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