Using Hydroxyethyl Starch to Prevent Low Blood Pressure After Spinal Anesthesia in Cesarean Sections
6% Hydroxyethyl Starch (130/0.4) Coload for Postspinal Anesthesia Hypotension in Patients Undergoing Caesarean Section: A Randomized Sequential Allocation Dose-finding Study
This study is testing how much Hydroxyethyl starch can help prevent low blood pressure in women having a cesarean section after receiving spinal anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | General Hospital of Ningxia Medical University Academic / other |
| Locations | 1 site (Yinchuan, Ningxia) |
| Trial ID | NCT05475886 on ClinicalTrials.gov |
What this trial studies
This study investigates the effective doses (ED50 and ED90) of a 6% Hydroxyethyl starch (130/0.4) infusion to prevent low blood pressure following spinal anesthesia in patients undergoing cesarean sections. Post-spinal anesthesia hypotension is a common complication, affecting a significant percentage of patients if not proactively managed. The study aims to determine the optimal infusion dose that can effectively mitigate this adverse effect, thereby improving patient outcomes during and after surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy pregnant women aged 18-40, scheduled for elective cesarean sections under spinal anesthesia.
Not a fit: Patients with severe obesity, chronic hypertension, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of hypotension in patients undergoing cesarean sections, leading to safer surgical experiences.
How similar studies have performed: Previous studies have shown that colloid fluid coload can effectively prevent post-spinal anesthesia hypotension, suggesting a promising approach for this investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-40 years * Primipara or multipara * Singleton pregnancy ≥ 37 weeks * American Society of Anesthesiologists physical status classification I to II * Scheduled for elective cesarean section under spinal anesthesia Exclusion Criteria: * Body height \< 150 cm * Body weight \> 100 kg or body mass index (BMI) ≥ 40 kg/m2 * Eclampsia or chronic hypertension or baseline blood pressure ≥ 160mmHg * Hemoglobin \< 7g/dl * Coagulation or renal function disorders * Known allergy to hydroxyethyl starch * Fetal distress, or known fetal developmental anomaly
Where this trial is running
Yinchuan, Ningxia
- General Hospital of Ningxia Medical University — Yinchuan, Ningxia, China (Recruiting)
Study contacts
- Study coordinator: Yi Chen, M.D.
- Email: czzyxgp@163.com
- Phone: 86-951-674-3252
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.