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

Not Applicable

Recruiting

• Conditions: Analgesia
• Interventions: Other: BMI≥30; Combined Spinal Epidural Anesthesia

• Registration Number: NCT06018805
• Lead Sponsor: Ataturk University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-24
• Study First Submitted: 2023-07-24
• Study First Submitted QC: 2023-08-29
• Study First Posted: 2023-08-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-06
• Primary Completion: 2024-11-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Body Mass Index≥30 kg/m2	BMI≥30; Combined Spinal Epidural Anesthesia	Pregnant women with a Body Mass Index≥30 kg/m2 will be included.

Primary Outcome Measures

Name	Time	Method
QTc interval	first 2 hour starting from the time of CSE performed.	The primary aim of this study was to reveal the difference in QTc interval between groups.

Trial Locations

Locations (1)

Ataturk University; 🇹🇷 Erzurum, Turkey