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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06018805
• Other study ID #: B.30.2.ATA.0.01.00/408
• Status: Recruiting
• Phase: N/A
• Start date: July 24, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Ataturk University
• Contact: Mehmet Aksoy
• Phone: +905058193526
• Email: drmaksoy[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Ataturk University	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.