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临床试验/NCT06018805
NCT06018805招募中不适用

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

Ataturk University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年7月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
QTc interval

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Participants with BMI≥30 and BMI values between 18.5 and 24.9.

排除标准

  • 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.

结局指标

主要结局

QTc interval

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mehmet AKSOY

Principal Investigator

Ataturk University

研究点 (2)

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