## Protocol Section
### Identification Module
**NCT ID:** NCT06414811

**Brief Title:** Tapse/Pasp General Anesthesia

**Official Title:** Prediction of TAPSE/PASP Ratio for Hypotension Due to General Anesthesia Induction

#### Organization Study ID Info
**ID:** 2024-44
#### Organization
**Class:** OTHER
**Full Name:** Aydin Adnan Menderes University
### Status Module
#### Completion Date
**Date:** 2025-03-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-01-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-15

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Aydin Adnan Menderes University

#### Responsible Party

**Investigator Affiliation:** Aydin Adnan Menderes University

**Investigator Full Name:** ferdi gülaştı

**Investigator Title:** ASS. PROF. DR

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** TAPSE, one of the methods for evaluating right ventricular systolic function; It is a bar parameter that can easily measure apex-basal shortening and provides specific information about global RV function. TAPSE/PASP can be calculated as load-independent parameters to evaluate RV function. Because RV function is sensitive to change in afterload, known as the RV-pulmonary circulation (PC) connection.

This study aims to identify patients who are candidates for hypotensive events due to general anesthesia in a hemodynamically stable population.

**Detailed Description:** TAPSE, one of the methods for evaluating right ventricular systolic function; It is a bar parameter that can easily measure apex-basal shortening and provides specific information about global RV function. TAPSE/PASP can be calculated as load-independent parameters to evaluate RV function. Because RV function is sensitive to change in afterload, known as the RV-pulmonary circulation (PC) connection.

This study aims to identify patients who are candidates for hypotensive events due to general anesthesia in a hemodynamically stable population.

Patients will be measured by transthoracic echocardiography in the preoperative period, 15-30 minutes before induction.

Basal hemodynamic parameters and non-invasive and/or hemodynamic values will be recorded every two minutes after induction until surgical incision.Patients with a 30% decrease in SBP from the baseline and a decrease in MAP below 65 mmHg in the first 10 minutes after anesthesia induction will be considered to have hypotension. Patients will be divided into 2 groups: 'with' and 'without' hypotension.

### Conditions Module

**Conditions:**

- Hypotension

**Keywords:**

- TAPSE

- PASP

- GENERAL ANESTHESİA

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 52

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 1 Day

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients with a 30% decrease in SBP from baseline and a decrease in MAP below 65 mmHg in the first 10 minutes after anesthesia induction will be considered to have hypotension.

**Intervention Names:**

- Other: HYPOTENSİON

**Label:** Hypotension

#### Arm Group 2

**Description:** Patients who do not have a 30% decrease from the baseline in SBP and a decrease in MAP below 65 mmHg in the first 10 minutes after anesthesia induction will be considered as not having hypotension.

**Label:** none hypotension

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Hypotension

**Description:** MAP below 55 mmHg or long-term (2 minutes or more) hypotensive attacks will be treated with ephedrine 0.1mg/kg.

**Name:** HYPOTENSİON

**Other Names:**

- TREATMENT

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Intraoperative systolic arterial tension, diastolic arterial tension and mean arterial tension will be taken and recorded for the patients.

**Measure:** 1. tension

**Time Frame:** 4-5 hours]

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Written informed consent;
2. 18-75 years old
3. ASA Physical Status 1-3;
4. Patients planned for surgery

Exclusion Criteria:

1. The patient is pregnant
2. After cardiac surgery
3. Severe pulmonary hypertension
4. Severe valve disease
5. Hypertrophic or dilated cardiomyopathy
6. Presence of acute myocardial infarction
7. Patients with severe visual or hearing impairment/disability
8. ASA physical status IV or V
9. Ischemic heart disease, conduction disorder.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** ASA1-3 patients aged 18-75 who will undergo elective surgery

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ferdigulasti@gmail.com

**Name:** ferdi gülaştı

**Phone:** +905054929650

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Aydın

**Country:** Turkey

**Facility:** Ferdi Gülaştı

**Zip:** 09020

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M10072

- Name: Hypotension

- Relevance: HIGH

- As Found: Hypotension

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007022

- Term: Hypotension

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AnAg

- Name: Antihypertensive Agents

- Abbrev: VaCoAg

- Name: Vasoconstrictor Agents

- Abbrev: CNSSti

- Name: Central Nervous System Stimulants

- Abbrev: Resp

- Name: Respiratory System Agents

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M4277

- Name: Antihypertensive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7966

- Name: Ephedrine

- Relevance: LOW

- As Found: Unknown

- ID: M27586

- Name: Pseudoephedrine

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
