RecruitingNot ApplicableNCT07440667

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

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


Sponsor

Nigde Omer Halisdemir University

Enrollment

160 participants

Start Date

Mar 4, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria4

  • Female patients aged 18-45 years
  • ASA physical status II
  • Scheduled for elective cesarean section under spinal anesthesia
  • Provision of written informed consent

Exclusion Criteria10

  • 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

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Interventions

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

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

OTHERLiberal intraoperative crystalloid fluid strategy (>3 mL/kg/h)

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


Locations(1)

Niğde Ömer Halisdemir University Hospital

Niğde, Merkez, Turkey (Türkiye)

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NCT07440667


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