Using norepinephrine to treat low blood pressure in pregnant women during cesarean sections
Effect of Prophylactic Intravenous Norepinephrine Infusion on Maternal Hypotension After Combined Lumbar and Epidural Anaesthesia for Caesarean Section
This study tests if norepinephrine can help pregnant women maintain stable blood pressure during elective cesarean sections when using combined anesthesia.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | The Third People's Hospital of Bengbu Government |
| Locations | 1 site (Bengbu, Anhui) |
| Trial ID | NCT06498115 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of norepinephrine in managing maternal hypotension during elective cesarean sections performed under combined lumbar and epidural anesthesia. The study aims to determine the effective doses (ED50 and ED95) of norepinephrine for stabilizing blood pressure in this context. A total of 100 patients will be enrolled, and the dosage will be calculated using a specific sequential distribution method. The trial focuses on understanding how norepinephrine compares to traditional treatments for this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy pregnant women undergoing elective cesarean sections at full term with no significant medical history.
Not a fit: Patients with pre-existing conditions such as hypertension, cardiovascular diseases, or diabetes mellitus may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective method for managing low blood pressure in pregnant women during surgery, improving maternal and fetal outcomes.
How similar studies have performed: While norepinephrine has been explored in other contexts, its specific application for maternal hypotension during cesarean sections is relatively novel and under-researched.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Inclusion criteria included women undergoing elective caesarean section undergoing combined lumbar and rigid anaesthesia, healthy singleton pregnancies at full term (more than 37 weeks gestation), American Society of Anaesthesiologists physical status I or II, body weight between 50-100 kg, height between 150-180 cm, and fasting for more than 8 hours. Exclusion Criteria: The exclusion criteria included individuals with hypertension, cardiovascular diseases, preeclampsia, arrhythmias, diabetes mellitus, spinal cord malformations, abnormal fetal conditions, and those who declined to participate in the study.
Where this trial is running
Bengbu, Anhui
- The Third People's Hospital of Bengbu — Bengbu, Anhui, China (Recruiting)
Study contacts
- Study coordinator: Chengfei Xu
- Email: bbxcfpain@163.com
- Phone: +8615255098850
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.