Performance Evaluation of ANI in Patients Under General Anesthesia With Remimazolam

NCT06432894 | Recruiting

• 1 other identifier: Ilsan_Cha_2023-04-003-005
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Measurement

Keywords

Remimazolam; Remifentanil; Analgesia Nociception Index (ANI)

Outcome Measures

Primary Outcomes (1)

• ANI values

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

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

Secondary Outcomes (5)

• Heart Rate (HR) change

  Every 2 seconds for 2.5 minutes before and Every 2 seconds for 2.5 minutes after pain stimulation

• Patient state index (PSI) 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)

• Effect site concentration of remifentanil

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

Other Outcomes (1)

• Hemodynamic change

  within 5 minutes of pain stimulus

Study Arms (1)

observation

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

Combination Product: Analgesia Nociception Index, remimazolam

Interventions

Analgesia Nociception Index, remimazolam COMBINATION_PRODUCT

The purpose of this study is to determine the validity of ANI in patients undergoing surgery with remifentanil and remimazolam. During this study, remimazolam infusion rate is determined by the pharmacopoeia. Remifentanil infusion rate is determined based on the patient's vital signs, systemic status and pain levels. And remifentanil is administrated via targeted infusion control using the Minto model. ANI scores, vital signs, remifentanil infusion rate are collected at predetermined time points according to the protocol from the start to the end of the surgery.

observation

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who visit the hospital and undergo surgery

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Catholic Kwandong University: lead

Study Sites (1)

Catholic-Kwandong University, School of Medicine

Incheon, 22711, South Korea

RECRUITING

MeSH Terms

Interventions

remimazolam

Study Officials

• Young Joo

  Ilsan Cha hospital

  STUDY CHAIR

Central Study Contacts

Jungmin Lee

CONTACT

821041929159; jminyi19@gmail.com

Joohyun Lee

CONTACT

821074200912; hightothesky1004@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 29, 2024
• Study Start: April 23, 2024
• Primary Completion: June 11, 2025
• Study Completion: June 11, 2025
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

KR (1)