## Protocol Section
### Identification Module
**NCT ID:** NCT06432894

**Brief Title:** Performance Evaluation of ANI in Patients Under General Anesthesia With Remimazolam

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

#### Organization Study ID Info
**ID:** Ilsan_Cha_2023-04-003-005
#### Organization
**Class:** OTHER
**Full Name:** Catholic Kwandong University
### Status Module
#### Completion Date
**Date:** 2025-06-11

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-29

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-06-11

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-23

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Catholic Kwandong University

#### Responsible Party

**Investigator Affiliation:** Catholic Kwandong University

**Investigator Full Name:** Jungmin Lee

**Investigator Title:** Assistant Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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 Module

**Conditions:**

- Pain Measurement

**Keywords:**

- Remimazolam

- Remifentanil

- Analgesia Nociception Index (ANI)

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 20 Months

### Arms Interventions Module

#### Arm Group 1

**Description:** 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

**Intervention Names:**

- Combination Product: Analgesia Nociception Index, remimazolam

**Label:** observation

### Interventions

#### Intervention 1

**Arm Group Labels:**

- observation

**Description:** 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.

**Name:** Analgesia Nociception Index, remimazolam

**Type:** COMBINATION_PRODUCT

### Outcomes Module

#### Other Outcomes

**Description:** When there are changes of heart rate or blood pressure more than 20% from baseline within 5 minutes of pain stimulus

**Measure:** Hemodynamic change

**Time Frame:** within 5 minutes of pain stimulus

#### Primary Outcomes

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

**Measure:** ANI values

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

#### Secondary Outcomes

**Description:** 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.

**Measure:** 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

**Description:** 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.

**Measure:** 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

**Description:** 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

**Measure:** Blood Pressure change

**Time Frame:** Every 2 seconds for 2.5 minutes before and Every 2 seconds for 2.5 minutes after pain stimulation

**Description:** 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.

**Measure:** Remimazolam infusion rate

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

**Description:** Remifentanil is an opioid and can affect pain levels when given a pain stimulus.

**Measure:** Effect site concentration of remifentanil

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

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 79 Years

**Minimum Age:** 20 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients who visit the hospital and undergo surgery

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jminyi19@gmail.com

**Name:** Jungmin Lee

**Phone:** 821041929159

**Role:** CONTACT

**Contact 2:**

**Email:** hightothesky1004@gmail.com

**Name:** Joohyun Lee

**Phone:** 821074200912

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Incheon

**Contacts:**

***Contact 1:***

- **Email:** jminyi19@gmail.com

- **Name:** Jungmin Lee, MD

- **Phone:** 821041929159

- **Role:** CONTACT

***Contact 2:***

- **Email:** hightothesky1004@gmail.com

- **Name:** Joohyun Lee, MD

- **Phone:** 821074200912

- **Role:** CONTACT

**Country:** Korea, Republic of

**Facility:** Catholic-Kwandong University, School of Medicine

**Status:** RECRUITING

**Zip:** 22711

#### Overall Officials

**Official 1:**

**Affiliation:** Ilsan Cha hospital

**Name:** Young Joo

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

- CSR

- ANALYTIC_CODE

**IPD Sharing:** YES

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Analg

- Name: Analgesics

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M1696

- Name: Remifentanil

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
