Performance Evaluation of ANI in Patients Under General Anesthesia With Remimazolam

NCT ID: NCT06432894

Last Updated: 2024-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-23

Study Completion Date

2025-06-11

Brief Summary

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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

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Conditions

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Pain Measurement

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Analgesia Nociception Index, remimazolam

Intervention Type 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.

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catholic Kwandong University

OTHER

Sponsor Role lead

Responsible Party

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Jungmin Lee

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Young Joo

Role: STUDY_CHAIR

Ilsan Cha hospital

Locations

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Catholic-Kwandong University, School of Medicine

Incheon, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jungmin Lee

Role: CONTACT

821041929159

Joohyun Lee

Role: CONTACT

821074200912

Facility Contacts

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Jungmin Lee, MD

Role: primary

821041929159

Joohyun Lee, MD

Role: backup

821074200912

Other Identifiers

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Ilsan_Cha_2023-04-003-005

Identifier Type: -

Identifier Source: org_study_id

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