Performance Evaluation of Analgesia Nociception Index (ANI) in Patients Under General Anaesthesia With Remimazolam: a Prospective Observational Study

Catholic Kwandong University1 site in 1 country30 target enrollmentApril 23, 2024

ConditionsPain Measurement

Overview

Phase: N/A
Intervention: Not specified
Conditions: Pain Measurement
Sponsor: Catholic Kwandong University
Enrollment: 30
Locations: 1
Primary Endpoint: ANI values
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine whether Analgesia Nociception Index (ANI) can effectively reduce the dose of opioid in patients who underwent general anesthesia using remimazolam.

Registry

clinicaltrials.gov

Start Date

April 23, 2024

End Date

June 11, 2025

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Catholic Kwandong University

Responsible Party

Principal Investigator

Jungmin Lee

Assistant Professor

Catholic Kwandong University

Eligibility Criteria

Inclusion Criteria

•aged 20-79 years under general anaesthesia with remimazolam
•scheduled to undergo robotic surgery
•in American Society of Anesthesiologists physical class 1, 2 or 3
•voluntarily agree in writing to participate in this clinical study

Exclusion Criteria

•Conditions affecting the autonomic nervous system
•other conditions or disease that may cause acute or chronic pain
•the NRS before induction of anesthesia is 1 or over
•When taking medications that may affect the autonomic nervous system
•In other cases where the investigator deems the subject unsuitable for this trial

Outcomes

Primary Outcomes

ANI values

Time Frame: During Surgery (at the points of intubation, skin incision, CO2 insufflation, TOF stimulation, and hemodynamic change)

A value indicating the degree of pain calculated by ANI's algorithm

Secondary Outcomes

Heart Rate (HR) change(Every 2 seconds for 2.5 minutes before and Every 2 seconds for 2.5 minutes after pain stimulation)
Blood Pressure change(Every 2 seconds for 2.5 minutes before and Every 2 seconds for 2.5 minutes after pain stimulation)
Remimazolam infusion rate(During Surgery (at the points of intubation, skin incision, CO2 insufflation, TOF stimulation, and hemodynamic change))
Patient state index (PSI) change(Every 2 seconds for 2.5 minutes before and Every 2 seconds for 2.5 minutes after pain stimulation)
Effect site concentration of remifentanil(During Surgery (at the points of intubation, skin incision, CO2 insufflation, TOF stimulation, and hemodynamic change))