- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06434870
Effect of Spinal Anesthesia in Elective Cesarean Cases on Frontal QRS Angle in Anemic and Non-Anemic Patients
Comparison of the Effect of Spinal Anesthesia Applied in Elective Cesarean Cases on Frontal QRS Angle in Anemic and Non-Anemic Patients
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.
Study Overview
Status
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: ahmet kaya
- Phone Number: 00905327010609
- Email: ahmet.kaya@sbu.edu.tr
Study Contact Backup
- Name: mahmut alp karahan
- Phone Number: 00905327808997
- Email: mahmutalp_k@yahoo.com
Study Locations
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Şanlıurfa, Turkey, 63050
- Recruiting
- University of Health Science Turkey Sanliurfa Mehmet Akif Inan Training and Research Hospital
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Contact:
- ahmet kaya
- Phone Number: 00905327010609
- Email: ahmet.kaya@sbu.edu.tr
-
Contact:
- mahmut alp karahan
- Phone Number: 00905327808997
- Email: mahmutalp_k@yahoo.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Patients who had undergone Elective Cesarean Surgery with anemia
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. |
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Patients who had undergone Elective Cesarean Surgery without anemia
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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The measurements to be taken include QRS, frontal QRS, QRS angle and Tp-e interval. (T1)
Time Frame: preoperatively
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preoperatively
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The measurements to be taken include QRS, frontal QRS, QRS angle and Tp-e interval.(T2)
Time Frame: after spinal anaesthesia
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after spinal anaesthesia
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The measurements to be taken include QRS, frontal QRS, QRS angle and Tp-e interval.(T3)
Time Frame: 5 min after spinal anaesthesia
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5 min after spinal anaesthesia
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The measurements to be taken include QRS, frontal QRS, QRS angle and Tp-e interval.(T4)
Time Frame: 5 min after spinal anaesthesia
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5 min after spinal anaesthesia
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The measurements to be taken include QRS, frontal QRS, QRS angle and Tp-e interval.(T5)
Time Frame: 10 min after spinal anaesthesia
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10 min after spinal anaesthesia
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MAIEAH630004
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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