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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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• Female patients aged 18-45 years

• ASA physical status II

• Scheduled for elective cesarean section under spinal anesthesia

• Provision of written informed consent

Locations
Other Locations
Turkey
Niğde Ömer Halisdemir University Hospital
RECRUITING
Niğde
Contact Information
Primary
Pınar Erdoğan, Assoc. Prof.
pinar.erdogan@ohu.edu.tr
+905233646954
Backup
Seval Kılbasanlı, MD
pinar.erdogan@ohu.edu.tr
+905057246364
Time Frame
Start Date: 2026-03-04
Estimated Completion Date: 2027-01-30
Participants
Target number of participants: 160
Treatments
Experimental: Restrictive intraoperative fluid strategy (≤3 mL/kg/h)
Participants undergoing elective cesarean section under spinal anesthesia will receive intraoperative crystalloid at a target average infusion rate of ≤3 mL/kg/h. Standardized spinal anesthesia technique and intraoperative management will be applied. Hypotension will be treated according to the predefined rescue protocol (e.g., ephedrine and/or additional fluid bolus as clinically indicated).
Active_comparator: Liberal intraoperative fluid strategy (>3 mL/kg/h)
Participants undergoing elective cesarean section under spinal anesthesia will receive intraoperative crystalloid at a target average infusion rate of \>3 mL/kg/h. Standardized spinal anesthesia technique and intraoperative management will be applied. Hypotension will be treated according to the predefined rescue protocol (e.g., ephedrine and/or additional fluid bolus as clinically indicated).
Related Therapeutic Areas
Sponsors
Leads: Nigde Omer Halisdemir University

This content was sourced from clinicaltrials.gov