Performance Evaluation of ANI in Patients Under General Anesthesia With Remimazolam

Recruiting

• Conditions: Pain Measurement
• Interventions: Combination Product: Analgesia Nociception Index, remimazolam

• Registration Number: NCT06432894
• Lead Sponsor: Catholic Kwandong University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-23
• Status Verified: 2024-05
• Study First Submitted: 2024-05-17
• Study First Submitted QC: 2024-05-22
• Study First Posted: 2024-05-29
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-30
• Primary Completion: 2025-06-11
• Study Completion: 2025-06-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patients

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
observation	Analgesia Nociception Index, remimazolam	Patients * aged 20-80 years under general anaesthesia with remimazolam * scheduled to undergo robotic surgery * in American Society of Anesthesiologists physical class 1, 2 or 3

Primary Outcome Measures

Name	Time	Method
ANI values	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 Outcome Measures

Name	Time	Method
Heart Rate (HR) change	Every 2 seconds for 2.5 minutes before and Every 2 seconds for 2.5 minutes after pain stimulation	Because the ANI value is calculated using the change in HR, it is measured to correlate the change in ANI value with the change in HR due to pain.
Blood Pressure change	Every 2 seconds for 2.5 minutes before and Every 2 seconds for 2.5 minutes after pain stimulation	When a patient feels pain, it stimulates the autonomic nervous system to change blood pressure. This change is measured to determine how much pain the patient is feeling
Remimazolam infusion rate	During Surgery (at the points of intubation, skin incision, CO2 insufflation, TOF stimulation, and hemodynamic change)	Remimazolam is a sedative. The infusion rate of remimazolam correlates with sedation level. And it is measured to determine if sedation level correlates with ANI values when pain stimuli are given.
Patient state index (PSI) change	Every 2 seconds for 2.5 minutes before and Every 2 seconds for 2.5 minutes after pain stimulation	The PSI is an indicator of a patient's depth of sedation and is calculated based on EEG, which can change in response to painful stimuli. The PSI score is expressed as a number between 0 and 100, and it is usually recommended to maintain under 60 during surgery. An increase in the PSI score can indicates the degree of pain stimulus and can be used as an indicator to assess the validity of the ANI value.
Effect site concentration of remifentanil	During Surgery (at the points of intubation, skin incision, CO2 insufflation, TOF stimulation, and hemodynamic change)	Remifentanil is an opioid and can affect pain levels when given a pain stimulus.

Trial Locations

Locations (1)

Catholic-Kwandong University, School of Medicine; 🇰🇷 Incheon, Korea, Republic of