Restrictive versus liberal IV fluids during elective cesarean with spinal anesthesia
A Prospective Randomized Controlled Trial Comparing Restrictive and Liberal Intraoperative Fluid Strategies on Postoperative Nausea and Vomiting and Gastrointestinal Recovery After Elective Cesarean Section Under Spinal Anesthesia
This trial will test whether giving less versus more IV fluids during spinal anesthesia reduces nausea and speeds bowel recovery for women having an elective cesarean.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Nigde Omer Halisdemir University Academic / other |
| Locations | 1 site (Niğde, Merkez) |
| Trial ID | NCT07440667 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-center, randomized, parallel-group trial comparing restrictive (≤3 mL/kg/h) and liberal (>3 mL/kg/h) intraoperative crystalloid strategies in women undergoing elective cesarean section under spinal anesthesia. Eligible patients aged 18–45 with ASA II will be randomized 1:1 at Niğde Ömer Halisdemir University Hospital. The primary outcome is the incidence of postoperative nausea and vomiting within 24 hours, and secondary outcomes include postdural puncture headache, time to first flatus, hypotension frequency, and vasopressor requirements. Intraoperative hemodynamics, fluid volumes, and postoperative recovery metrics will be recorded to compare maternal outcomes between the two fluid regimens.
Who should consider this trial
Good fit: Women aged 18–45 with ASA physical status II scheduled for elective cesarean under spinal anesthesia who can give informed consent are the intended participants.
Not a fit: Patients with preeclampsia/eclampsia, significant cardiac, renal, or hepatic failure, coagulopathy, emergency cesarean, or those converted to general anesthesia are excluded and unlikely to benefit from the study interventions.
Why it matters
Potential benefit: If successful, the selected fluid strategy could reduce nausea and speed gastrointestinal recovery after cesarean, improving comfort and informing optimal fluid management.
How similar studies have performed: Previous studies comparing restrictive and liberal intraoperative fluids in obstetric and non-obstetric surgery have shown mixed results, so the optimal approach remains unresolved.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female patients aged 18-45 years * ASA physical status II * Scheduled for elective cesarean section under spinal anesthesia * Provision of written informed consent Exclusion Criteria: * Emergency cesarean section * Preeclampsia or eclampsia * Known cardiac failure * Known renal failure * Known hepatic failure * Coagulopathy * Contraindication to spinal anesthesia * Conversion to general anesthesia * Major technical complications during spinal anesthesia * Refusal to participate
Where this trial is running
Niğde, Merkez
- Niğde Ömer Halisdemir University Hospital — Niğde, Merkez, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Pınar Erdoğan, Assoc Prof — Niğde Ömer Halisdemir University Hospital
- Study coordinator: Pınar Erdoğan, Assoc. Prof.
- Email: pinar.erdogan@ohu.edu.tr
- Phone: +905233646954
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.