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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Body Mass Index≥30 kg/m2 | Active Comparator | Pregnant women with a Body Mass Index≥30 kg/m2 will be included. |
|
| Body Mass Index: 18,5 - 24,9 kg/m2 | Active Comparator | Pregnant women with a Body Mass Index between 18.5 and 24.9 kg/m2 will be included. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMI≥30; Combined Spinal Epidural Anesthesia | Other | 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mehmet Aksoy | Contact | +905058193526 | drmaksoy@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mehmet Aksoy | Ataturk University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ataturk University | Recruiting | Erzurum | 25100 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31198727 | Background | Kumar T, Jha K, Sharan A, Sakshi P, Kumar S, Kumari A. Study of the effect of obesity on QT-interval among adults. J Family Med Prim Care. 2019 May;8(5):1626-1629. doi: 10.4103/jfmpc.jfmpc_168_19. | |
| 35562669 | Background | Song JH, Yang C, Lee W, Kim H, Kim Y, Kim H. QTc interval prolongation due to spinal anesthesia in patients with and without diabetes: an observational study. BMC Anesthesiol. 2022 May 13;22(1):143. doi: 10.1186/s12871-022-01614-8. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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|
| BMI:18,5-24,9; Combined Spinal Epidural Anesthesia | Other | 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. |
|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |