Actively Recruiting
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
Led by Nigde Omer Halisdemir University · Updated on 2026-03-10
160
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of different fluid administration strategies during elective cesarean sections performed under spinal anesthesia. This trial compares restrictive (≤3 mL/kg/h) and liberal (>3 mL/kg/h) crystalloid fluid approaches to understand their impact on maternal outcomes such as postoperative nausea and vomiting (PONV), postdural puncture headache (PDPH), gastrointestinal recovery, and intraoperative blood pressure stability. Participants will be randomly assigned to receive either a restrictive or liberal fluid infusion during surgery, with all other anesthetic procedures standardized. Hypotension during surgery will be managed using a predefined rescue protocol including medications like ephedrine and additional fluid boluses as needed. The study is designed as a prospective, single-center, randomized controlled trial. Throughout the study, researchers will monitor the incidence of PONV within 24 hours after surgery as the primary outcome. Secondary outcomes include PDPH severity, time to first flatus indicating bowel recovery, frequency of hypotension during surgery, and vasopressor use. Data on fluid administration and hemodynamic parameters will be collected to evaluate the effects of the fluid strategies on postoperative recovery and maternal health.
CONDITIONS
Brief Title
Restrictive vs Liberal Intraoperative Fluid Strategy and Postoperative Outcomes After Elective Cesarean Section
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18-45 years
- ASA physical status II
- Scheduled for elective cesarean section under spinal anesthesia
- Provision of written informed consent
You will not qualify if you...
- 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
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Intraoperative period
Participants undergo elective cesarean section under spinal anesthesia receiving either a restrictive or liberal intraoperative crystalloid fluid strategy during surgery.
1 visit (surgical procedure day)
Duration - Up to 72 hours postoperatively
Participants are monitored for postoperative nausea and vomiting, postdural puncture headache, and gastrointestinal recovery for up to 72 hours after surgery.
1 to 3 visits within 72 hours after surgery
Trial Site Locations
Total: 1 location
1
Niğde Ömer Halisdemir University Hospital
Niğde, Merkez, Turkey (Türkiye), 51240
Actively Recruiting
Research Team
P
Pınar Erdoğan, Assoc. Prof.
S
Seval Kılbasanlı, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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