The Effect of Combined Spinal Epidural Anaesthesia on QTc Interval Undergoing Cesarean Section

Study Overview
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Brief Summary
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Cesarean section is the operation to deliver the fetus, placenta and membranes by making an abdominal incision in the uterus. Cesarean section is performed for reasons such as head-pelvis incompatibility, fetal malposition, fetal distress, and previous cesarean section. The most important side effects of spinal anaesthesia are problems such as hypotension, bradycardia, low back pain, headache, nausea, vomiting, meningitis, meningismus, and urinary retention. Combined spinal-epidural (BSI) anaesthesia is the application of spinal and epidural anaesthesia together. High-dose local anaesthetics can cause significant hypotension when the epidural block is administered alone. The administration of spinal anaesthesia alone causes changes in arterial resistance, stroke volume, heart rate, cardiac output and arterial blood pressure. Sympathetic blockade leads to arterial vasodilation, and arterial resistance may decrease by 5-20% during spinal anaesthesia. Due to the increased risk of maternal complications in obese pregnant, fetal morbidity and mortality have increased. In addition, supine hypotension syndrome is a common problem in obese pregnant women. The aim of this study is to compare the change in QTc interval in obese and non-obese term pregnancies planned for elective cesarean section with combined spinal epidural anaesthesia. Thus, it is aimed to develop new protocols that will minimize cardiac pathologies during and after surgery in obese pregnant women.

Official Title
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The Effect of Combined Spinal Epidural Anaesthesia on QTc Interval in Obese and Non-obese Parturients Undergoing Cesarean Section: A Comparative Study

Conditions
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Analgesia

Intervention / Treatment
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* Other: BMI≥30; Combined Spinal Epidural Anesthesia
* Other: BMI:18,5-24,9; Combined Spinal Epidural Anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with BMI≥30 and BMI values between 18.5 and 24.9. Exclusion Criteria: allergic to the drugs used in the study, who do not accept regional anesthesia, body mass index did not meet the inclusion criteria in the study, under 150 cm in height, who received treatment other than perinatal iron and vitamin drugs, smoking or drinking alcohol, with a known fetal anomaly, with placental disorders such as placenta previa, with multiple pregnancy have renal or liver disease, diagnosed with hypertension or preeclampsia, uncooperative and previously treated or currently receiving treatment for a psychiatric disorder Mothers who do not want to participate in the study will not be included in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Body Mass Index≥30 kg/m2<br>Pregnant women with a Body Mass Index≥30 kg/m2 will be included. | Other: BMI≥30; Combined Spinal Epidural Anesthesia<br>* Combined epidural spinal anesthesia will be performed with the loss of resistance method at constant volume and concentration ( in both patient groups. For QT interval measurements, ECG recordings will be taken before spinal anesthesia, 5 and 30 minutes after the block, and 60 and 120 minutes postoperatively.<br>|
| Active Comparator: Body Mass Index: 18,5 - 24,9 kg/m2<br>Pregnant women with a Body Mass Index between 18.5 and 24.9 kg/m2 will be included. | Other: BMI:18,5-24,9; Combined Spinal Epidural Anesthesia<br>* Combined epidural spinal anesthesia will be performed with the loss of resistance method at constant volume and concentration in both patient groups. For QT interval measurements, ECG recordings will be taken before spinal anesthesia, 5 and 30 minutes after the block, and 60 and 120 minutes postoperatively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QTc interval | The primary aim of this study was to reveal the difference in QTc interval between groups. | first 2 hour starting from the time of CSE performed. |