About this trial
Spinal anesthesia for elective cesarean section is frequently associated with hemodynamic instability and postoperative complications such as postoperative nausea and vomiting (PONV) and delayed gastrointestinal recovery. Although intraoperative fluid administration is routinely used to prevent spinal-induced hypotension, the optimal fluid strategy remains unclear. Both restrictive and liberal fluid approaches may influence maternal hemodynamics and postoperative outcomes through different physiological mechanisms.
This prospective, single-center, randomized controlled trial aims to compare restrictive (≤3 mL/kg/h) and liberal (\>3 mL/kg/h) intraoperative crystalloid fluid strategies in patients undergoing elective cesarean section under spinal anesthesia. The primary outcome is the incidence of PONV within the first 24 hours postoperatively. Secondary outcomes include postdural puncture headache (PDPH), time to first flatus, hypotension frequency, and vasopressor requirements.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female patients aged 18-45 years
ASA physical status II
Scheduled for elective cesarean section under spinal anesthesia
Provision of written informed consent
Disqualifiers
Emergency cesarean section
Preeclampsia or eclampsia
Known cardiac failure
Known renal failure
Trial design
Parallel
Treatments tested in this trial
Restrictive intraoperative crystalloid fluid strategy (≤3 mL/kg/h)
Other interventionIntraoperative crystalloid administration targeting an average rate of ≤3 mL/kg/h during elective cesarean section under spinal anesthesia.
Liberal intraoperative crystalloid fluid strategy (>3 mL/kg/h)
Other interventionIntraoperative crystalloid administration targeting an average rate of \>3 mL/kg/h during elective cesarean section under spinal anesthesia.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of postoperative nausea and vomiting (PONV)
Occurrence of nausea and/or vomiting within the first 24 hours after surgery, recorded as present or absent.
Secondary outcomes
Incidence and severity of postdural puncture headache (PDPH)
Occurrence of postdural puncture headache (PDPH) within 72 hours postoperatively. Severity will be assessed using a standardized pain scale (e.g., numerical rating scale).
Time to first flatus
Time (in hours) from the end of surgery to the first reported passage of flatus.
Frequency of intraoperative hypotension
Number of hypotensive episodes defined as systolic blood pressure \<90 mmHg or a decrease \>20% from baseline.
Total intraoperative vasopressor dose
Cumulative dose of ephedrine administered during surgery.
Sponsors and contacts
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