Niğde Ömer Halisdemir University Hospital
Niğde, Merkez, 51240, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07440667
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.
Interested in participating?
Request Info18 year–45 year
Female
Interventional
Not applicable
Niğde, Merkez, 51240, Turkey (Türkiye)
Location status: Recruiting
Spinal anesthesia is the preferred anesthetic technique for elective cesarean section; however, it is frequently associated with sympathetic blockade-induced hypotension. Intraoperative crystalloid administration is commonly used to mitigate hemodynamic instability, yet the optimal fluid strategy remains controversial. Liberal fluid administration may reduce the incidence or severity of hypotension but can contribute to tissue edema, including gastrointestinal wall edema, potentially delaying the recovery of bowel function. Conversely, restrictive fluid strategies may limit fluid overload but could increase vasopressor requirements and compromise splanchnic perfusion. The balance between these approaches and their influence on postoperative maternal outcomes has not been clearly established.
Postoperative nausea and vomiting (PONV) remains one of the most common and distressing complications following cesarean section. Hemodynamic fluctuations, vasopressor use, and visceral perfusion changes may all contribute to its development. In addition, delayed gastrointestinal recovery and postdural puncture headache (PDPH) are relevant postoperative outcomes that may be influenced by intraoperative fluid management.
This prospective, single-center, parallel-group randomized controlled trial is designed to compare two intraoperative crystalloid fluid strategies in patients undergoing elective cesarean section under spinal anesthesia. Patients will be randomized in a 1:1 ratio to receive either a restrictive (≤3 mL/kg/h) or a liberal (>3 mL/kg/h) intraoperative fluid approach. All other anesthetic procedures, spinal technique, and perioperative management will be standardized according to institutional protocol.
The primary outcome of the study is the incidence of PONV within the first 24 postoperative hours. Secondary outcomes include the incidence and severity of PDPH, time to first flatus as a marker of gastrointestinal recovery, frequency of hypotension, and vasopressor requirements. Intraoperative hemodynamic parameters and fluid administration data will be recorded prospectively.
The study aims to clarify whether intraoperative fluid volume influences postoperative maternal recovery and to contribute evidence toward optimizing perioperative fluid management in elective cesarean section.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intraoperative crystalloid administration targeting an average rate of ≤3 mL/kg/h during elective cesarean section under spinal anesthesia.
Intraoperative crystalloid administration targeting an average rate of >3 mL/kg/h during elective cesarean section under spinal anesthesia.
Time frame: 0-24 hours postoperatively
Occurrence of nausea and/or vomiting within the first 24 hours after surgery, recorded as present or absent.
Time frame: 24-72 hours postoperatively
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: Up to 72 hours postoperatively
Time (in hours) from the end of surgery to the first reported passage of flatus.
Time frame: Intraoperative period
Number of hypotensive episodes defined as systolic blood pressure <90 mmHg or a decrease >20% from baseline.
Time frame: Intraoperative period
Cumulative dose of ephedrine administered during surgery.
Contact information is provided by the study sponsor or research team.
Pınar Erdoğan, Assoc. Prof.
CONTACT
Seval Kılbasanlı, MD
CONTACT
Nigde Omer Halisdemir University
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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