Performance Evaluation of ANI in Patients Under General Anesthesia With Remimazolam

May 29, 2024 updated by: Jungmin Lee, Catholic Kwandong University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who visit the hospital and undergo surgery

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemodynamic change
Time Frame: within 5 minutes of pain stimulus
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic Kwandong University

Investigators

  • Study Chair: Young Joo, Ilsan Cha Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2024

Primary Completion (Estimated)

June 11, 2025

Study Completion (Estimated)

June 11, 2025

Study Registration Dates

First Submitted

May 17, 2024

First Submitted That Met QC Criteria

May 22, 2024

First Posted (Actual)

May 29, 2024

Study Record Updates

Last Update Posted (Actual)

May 30, 2024

Last Update Submitted That Met QC Criteria

May 29, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Ilsan_Cha_2023-04-003-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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