An interventional study of Restrictive intraoperative crystalloid fluid strategy (≤3 mL/kg/h) and Liberal intraoperative crystalloid fluid strategy (>3 mL/kg/h) in Cesarean Section, Postoperative Nausea and Vomiting (PONV) and Postdural Puncture Headache (PDPH), sponsored by Nigde Omer Halisdemir University. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-03-10.
Sponsored by Nigde Omer Halisdemir University · Not applicable, Interventional, and Treatment
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.
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.
638 studies on the registry are indexed under Postoperative Nausea and Vomiting; 110 are open to participants now.
This study's planned enrollment of 160 is above the median of 112 across 529 interventional studies indexed under Postoperative Nausea and Vomiting.
Browse Postoperative Nausea and Vomiting studies →Nigde Omer Halisdemir University is the lead sponsor of 93 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Other: Restrictive intraoperative crystalloid 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).
Other: Liberal 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.
Intraoperative crystalloid administration targeting an average rate of \>3 mL/kg/h during elective cesarean section under spinal anesthesia.
Incidence of postoperative nausea and vomiting (PONV)
Occurrence of nausea and/or vomiting within the first 24 hours after surgery, recorded as present or absent.
Time frame: 0-24 hours postoperatively
Incidence and severity of postdural puncture headache (PDPH)
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: 24-72 hours postoperatively
Time to first flatus
Time (in hours) from the end of surgery to the first reported passage of flatus.
Time frame: Up to 72 hours postoperatively
Frequency of intraoperative hypotension
Number of hypotensive episodes defined as systolic blood pressure \<90 mmHg or a decrease \>20% from baseline.
Time frame: Intraoperative period
Total intraoperative vasopressor dose
Cumulative dose of ephedrine administered during surgery.
Time frame: Intraoperative period
Plan to share: No — Individual participant data (IPD) will not be publicly shared due to institutional policies and ethical considerations related to patient confidentiality. De-identified data may be made available upon reasonable request to the corresponding investigator, subject to approval by the institutional ethics committee and data protection regulations.
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Jan 2027, 10 months after the start.
Of 181 non-industry interventional studies with no phase under Postoperative Nausea and Vomiting, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 10 months is below that.
Counting every sponsor, half of 181 studies reached it within 13 months; a quarter within 5 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Postoperative Nausea and Vomiting →
Nigde Omer Halisdemir University