Effects of combined spinal-epidural anesthesia on heart rhythm during cesarean section
The Effect of Combined Spinal Epidural Anaesthesia on QTc Interval in Obese and Non-obese Parturients Undergoing Cesarean Section: A Comparative Study
NA · Ataturk University · NCT06018805
This study is testing how a special type of anesthesia used during cesarean sections affects heart rhythm and blood pressure in certain patients.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Ataturk University (other) |
| Locations | 1 site (Erzurum) |
| Trial ID | NCT06018805 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of combined spinal-epidural anesthesia on the QTc interval in patients undergoing cesarean sections. It aims to assess how this anesthesia technique affects heart rhythm and potential side effects such as hypotension and bradycardia. Participants will include individuals with specific body mass index (BMI) criteria, and the study will monitor cardiovascular responses during the procedure. The goal is to enhance safety and efficacy in pain management for cesarean deliveries.
Who should consider this trial
Good fit: Ideal candidates are pregnant women with a BMI of 30 or higher or between 18.5 and 24.9 who are undergoing a cesarean section.
Not a fit: Patients with contraindications to regional anesthesia, significant comorbidities, or those who do not meet the BMI criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve anesthesia safety and reduce cardiovascular complications during cesarean sections.
How similar studies have performed: While there is existing literature on spinal and epidural anesthesia, this specific combination's effects on QTc interval during cesarean sections is less explored, making this study a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Erzurum
- Ataturk University — Erzurum, Turkey (RECRUITING)
Study contacts
- Study coordinator: Mehmet Aksoy
- Email: drmaksoy@hotmail.com
- Phone: +905058193526
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Analgesia