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

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ClinicalTrials.gov Identifier: NCT06018805
Recruitment Status : Recruiting
First Posted : August 31, 2023
Last Update Posted : February 6, 2024
Sponsor:
Information provided by (Responsible Party):
Mehmet AKSOY, Ataturk University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Analgesia Other: BMI≥30; Combined Spinal Epidural Anesthesia Other: BMI:18,5-24,9; Combined Spinal Epidural Anesthesia Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Combined Spinal Epidural Anaesthesia on QTc Interval in Obese and Non-obese Parturients Undergoing Cesarean Section: A Comparative Study
Actual Study Start Date : July 24, 2023
Estimated Primary Completion Date : November 30, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Body Mass Index≥30 kg/m2
Pregnant women with a Body Mass Index≥30 kg/m2 will be included.
 Other: BMI≥30; Combined Spinal Epidural Anesthesia
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.
Active Comparator: Body Mass Index: 18,5 - 24,9 kg/m2
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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,
  • 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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06018805


Contacts
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Contact: Mehmet Aksoy +905058193526 drmaksoy@hotmail.com

Locations
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Turkey
Ataturk University Recruiting
Erzurum, Turkey, 25100
Contact: Mehmet Aksoy    +905058193526    drmaksoy@hotmail.com   
Sponsors and Collaborators
Ataturk University
Investigators
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Study Director: Mehmet Aksoy Ataturk University
More Information
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Publications:

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Responsible Party: Mehmet AKSOY, Principal Investigator, Ataturk University
ClinicalTrials.gov Identifier: NCT06018805    
Other Study ID Numbers: B.30.2.ATA.0.01.00/408
First Posted: August 31, 2023    Key Record Dates
Last Update Posted: February 6, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs