Restrictive vs Liberal Intraoperative Fluid Strategy and Postoperative Outcomes After Elective Cesarean Section

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorNigde Omer Halisdemir University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Restrictive intraoperative crystalloid fluid strategy (≤3 mL/kg/h)

    Other intervention

    Intraoperative 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 intervention

    Intraoperative crystalloid administration targeting an average rate of \>3 mL/kg/h during elective cesarean section under spinal anesthesia.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Restrictive intraoperative fluid strategy (≤3 mL/kg/h)Experimental treatment 1 intervention
Group B: Liberal intraoperative fluid strategy (>3 mL/kg/h)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
0-24 hours postoperatively

Secondary outcomes

1

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 frame
24-72 hours postoperatively
2

Time to first flatus

Time (in hours) from the end of surgery to the first reported passage of flatus.

Time frame
Up to 72 hours postoperatively
3

Frequency of intraoperative hypotension

Number of hypotensive episodes defined as systolic blood pressure \<90 mmHg or a decrease \>20% from baseline.

Time frame
Intraoperative period
4

Total intraoperative vasopressor dose

Cumulative dose of ephedrine administered during surgery.

Time frame
Intraoperative period

Other outcomes

Sponsors and contacts

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