## Protocol Section
### Identification Module
**NCT ID:** NCT06434870

**Brief Title:** Effect of Spinal Anesthesia in Elective Cesarean Cases on Frontal QRS Angle in Anemic and Non-Anemic Patients

**Official Title:** Comparison of the Effect of Spinal Anesthesia Applied in Elective Cesarean Cases on Frontal QRS Angle in Anemic and Non-Anemic Patients

#### Organization Study ID Info
**ID:** MAIEAH630004
#### Organization
**Class:** OTHER
**Full Name:** Sanliurfa Mehmet Akif Inan Education and Research Hospital
### Status Module
#### Completion Date
**Date:** 2024-08-31

**Type:** ESTIMATED

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

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-08-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-20

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Sanliurfa Mehmet Akif Inan Education and Research Hospital

#### Responsible Party

**Investigator Affiliation:** Sanliurfa Mehmet Akif Inan Education and Research Hospital

**Investigator Full Name:** ahmet kaya

**Investigator Title:** assistant professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The QRS-T angle represents a novel marker of myocardial repolarisation. It is defined as the angle difference between the direction of ventricular depolarisation (QRS wave) and the direction of ventricular repolarisation (T wave). It is an indicator of instability in the electrophysiological properties of the myocardium and is associated with arrhythmias. The frontal QRS-T angle is a straightforward, cost-effective parameter that can be readily obtained from 12-lead electrocardiography.

The most prevalent arrhythmias during pregnancy are atrial arrhythmias. However, ventricular tachyarrhythmias are exceedingly rare during pregnancy and may be life-threatening.

Caesarean section is one of the most common surgical procedures. General anaesthesia, spinal anaesthesia and epidural anaesthesia can be employed in these patients. Spinal anaesthesia is a frequently employed method in caesarean section operations due to its rapid onset of effect, technical simplicity of application and higher probability of success.

In pregnant women, anaemia is defined as a haemoglobin concentration below 11 mg/dL in the first trimester, 11 mg/dL in the second trimester and 10.5 mg/dL in the third trimester.

**Detailed Description:** The QRS-T angle represents a novel marker of myocardial repolarisation. It is defined as the angle difference between the direction of ventricular depolarisation (QRS wave) and the direction of ventricular repolarisation (T wave). It is an indicator of instability in the electrophysiological properties of the myocardium and is associated with arrhythmias. The frontal QRS-T angle is a straightforward, cost-effective parameter that can be readily derived from 12-lead electrocardiography. The angle between the QRS and T waves is a useful indicator of myocardial repolarisation. It is associated with arrhythmias and instability in the electrophysiological properties of the myocardium. The frontal QRS-T angle is a simple, inexpensive parameter that can be easily obtained from 12-lead electrocardiography.

Pregnancy has a profound effect on the cardiovascular system. It results in an increase in blood volume, heart rate, venous pressure in the lower extremities, and cardiac output. Furthermore, it can result in a reduction in peripheral resistance and pulmonary vascular resistance, as well as a decline in blood pressure. Furthermore, it affects the cardiac conduction system, rendering patients more susceptible to arrhythmias. The most prevalent arrhythmias during pregnancy are atrial arrhythmias. Ventricular tachyarrhythmias are relatively uncommon during pregnancy and can be life-threatening.

One of the most common surgical procedures is caesarean section. General anaesthesia, spinal anaesthesia and epidural anaesthesia can be employed in these patients. Spinal anaesthesia is a frequently employed method in caesarean section operations due to its rapid onset of effect, technical ease of application and higher chance of success. In addition to the beneficial effects, direct cardiac and indirect cardiac side effects may be observed, such as vasodilatation due to sympathetic denervation, decreased right heart pressure and reflex bradycardia, which depend on the level of block.

In pregnant women, haemoglobin values below 11 mg/dL in the first trimester, 11 mg/dL in the second trimester and 10.5 mg/dL in the third trimester are considered to indicate anaemia.

The objective of this study was to investigate the effects of spinal anaesthesia in elective caesarean section cases on frontal QRS angle in anaemic and non-anaemic patients.

### Conditions Module

**Conditions:**

- Pregnancy Anemia

- Electrocardiography

- Anesthesia, Spinal

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** In pregnant women, haemoglobin values below 11 mg/dL in the first trimester, 11 mg/dL in the second trimester and 10.5 mg/dL in the third trimester indicate anaemia.

The group comprised patients with haemoglobin levels below 10.5 mg/dL.

**Label:** Patients who had undergone Elective Cesarean Surgery with anemia

#### Arm Group 2

**Description:** In pregnant women, haemoglobin values below 11 mg/dL in the first trimester, 11 mg/dL in the second trimester and 10.5 mg/dL in the third trimester indicate anaemia.

The group comprised patients with haemoglobin levels above 10.5 mg/dL.

**Label:** Patients who had undergone Elective Cesarean Surgery without anemia

### Outcomes Module

#### Primary Outcomes

**Measure:** The measurements to be taken include QRS, frontal QRS, QRS angle and Tp-e interval. (T1)

**Time Frame:** preoperatively

**Measure:** The measurements to be taken include QRS, frontal QRS, QRS angle and Tp-e interval.(T2)

**Time Frame:** after spinal anaesthesia

**Measure:** The measurements to be taken include QRS, frontal QRS, QRS angle and Tp-e interval.(T3)

**Time Frame:** 5 min after spinal anaesthesia

**Measure:** The measurements to be taken include QRS, frontal QRS, QRS angle and Tp-e interval.(T4)

**Time Frame:** 5 min after spinal anaesthesia

**Measure:** The measurements to be taken include QRS, frontal QRS, QRS angle and Tp-e interval.(T5)

**Time Frame:** 10 min after spinal anaesthesia

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Aged 18-45 years
* Patients with American Society of Anesthesiologists (ASA) II classification

Exclusion Criteria:

* Patients with rhythm disorders
* Patients with electrolyte disturbances
* Patients with liver and/or renal failure
* Obese patients (body mass index \> 30)
* Trauma patients
* Cancer patients
* ASA III-IV patients
* Patients who do not wish to participate in the study will be excluded.

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

**Study Population:** The study will include 100 patients aged 18-45 years with an American Society of Anesthesiologists (ASA) II classification who will undergo elective caesarean section.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ahmet.kaya@sbu.edu.tr

**Name:** ahmet kaya

**Phone:** 00905327010609

**Role:** CONTACT

**Contact 2:**

**Email:** mahmutalp_k@yahoo.com

**Name:** mahmut alp karahan

**Phone:** 00905327808997

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Şanlıurfa

**Contacts:**

***Contact 1:***

- **Email:** ahmet.kaya@sbu.edu.tr

- **Name:** ahmet kaya

- **Phone:** 00905327010609

- **Role:** CONTACT

***Contact 2:***

- **Email:** mahmutalp_k@yahoo.com

- **Name:** mahmut alp karahan

- **Phone:** 00905327808997

- **Role:** CONTACT

**Country:** Turkey

**Facility:** University of Health Science Turkey Sanliurfa Mehmet Akif Inan Training and Research Hospital

**Status:** RECRUITING

**Zip:** 63050

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4070

- Name: Anemia

- 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: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: Analg

- Name: Analgesics

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M207501

- Name: Chrysarobin

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
