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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06434870
Other study ID # MAIEAH630004
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 20, 2024
Est. completion date August 31, 2024

Study information

Verified date May 2024
Source Sanliurfa Mehmet Akif Inan Education and Research Hospital
Contact ahmet kaya
Phone 00905327010609
Email ahmet.kaya@sbu.edu.tr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date August 31, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey University of Health Science Turkey Sanliurfa Mehmet Akif Inan Training and Research Hospital Sanliurfa

Sponsors (1)

Lead Sponsor Collaborator
Sanliurfa Mehmet Akif Inan Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The measurements to be taken include QRS, frontal QRS, QRS angle and Tp-e interval. (T1) preoperatively
Primary The measurements to be taken include QRS, frontal QRS, QRS angle and Tp-e interval.(T2) after spinal anaesthesia
Primary The measurements to be taken include QRS, frontal QRS, QRS angle and Tp-e interval.(T3) 5 min after spinal anaesthesia
Primary The measurements to be taken include QRS, frontal QRS, QRS angle and Tp-e interval.(T4) 5 min after spinal anaesthesia
Primary The measurements to be taken include QRS, frontal QRS, QRS angle and Tp-e interval.(T5) 10 min after spinal anaesthesia
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