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Clinical Trials/NCT06018805
NCT06018805
Recruiting
Not Applicable

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

Ataturk University1 site in 1 country50 target enrollmentJuly 24, 2023
ConditionsAnalgesia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Analgesia
Sponsor
Ataturk University
Enrollment
50
Locations
1
Primary Endpoint
QTc interval
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 24, 2023
End Date
December 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mehmet AKSOY

Principal Investigator

Ataturk University

Eligibility Criteria

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,

Outcomes

Primary Outcomes

QTc interval

Time Frame: 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.

Study Sites (1)

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