Performance Evaluation of ANI in Patients Under General Anesthesia With Remimazolam

Pain Measurement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06432894
• Other study ID #: Ilsan_Cha_2023-04-003-005
• Status: Recruiting
• Start date: April 23, 2024
• Est. completion date: June 11, 2025

Study information

• Verified date: May 2024
• Source: Catholic Kwandong University
• Contact: Jungmin Lee
• Phone: 821041929159
• Email: jminyi19[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 11, 2025
• Est. primary completion date: June 11, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain Measurement

Intervention

Combination Product:
• Analgesia Nociception Index, remimazolam
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.

Locations

Country	Name	City	State
Korea, Republic of	Catholic-Kwandong University, School of Medicine	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Catholic Kwandong University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hemodynamic change	When there are changes of heart rate or blood pressure more than 20% from baseline within 5 minutes of pain stimulus	within 5 minutes of pain stimulus
Primary	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	Heart Rate (HR) change	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.	Every 2 seconds for 2.5 minutes before and Every 2 seconds for 2.5 minutes after pain stimulation
Secondary	Patient state index (PSI) change	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.	Every 2 seconds for 2.5 minutes before and Every 2 seconds for 2.5 minutes after pain stimulation
Secondary	Blood Pressure change	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	Every 2 seconds for 2.5 minutes before and Every 2 seconds for 2.5 minutes after pain stimulation
Secondary	Remimazolam infusion rate	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.	During Surgery (at the points of intubation, skin incision, CO2 insufflation, TOF stimulation, and hemodynamic change)
Secondary	Effect site concentration of remifentanil	Remifentanil is an opioid and can affect pain levels when given a pain stimulus.	During Surgery (at the points of intubation, skin incision, CO2 insufflation, TOF stimulation, and hemodynamic change)