Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:40 AM
Study NCT ID:
NCT07440667
Status:
RECRUITING
Last Update Posted:
2026-03-10
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Restrictive vs Liberal Intraoperative Fluid Strategy and Postoperative Outcomes After Elective Cesarean Section
Sponsor:
Nigde Omer Halisdemir University
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: