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Идёт набор NCT07440667

Restrictive vs Liberal Intraoperative Fluid Strategy and Postoperative Outcomes After Elective Cesarean Section

Без фазы С лечением Cesarean Section Postoperative Nausea and Vomiting (PONV) Postdural Puncture Headache (PDPH) Postoperative Ileus

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Restrictive intraoperative crystalloid fluid strategy (≤3 mL/kg/h), Liberal intraoperative crystalloid fluid strategy (>3 mL/kg/h).
Кому может быть актуально
Состояния в реестре: Cesarean Section, Postoperative Nausea and Vomiting (PONV), Postdural Puncture Headache (PDPH), Postoperative Ileus. Базовые параметры: 18 лет — 45 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое Restrictive 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.
  • Другое 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.

Первичные конечные точки

  • Incidence of postoperative nausea and vomiting (PONV) [Срок оценки: 0-24 hours postoperatively]
Вторичные конечные точки (4)
  • Incidence and severity of postdural puncture headache (PDPH) [Срок оценки: 24-72 hours postoperatively]
  • Time to first flatus [Срок оценки: Up to 72 hours postoperatively]
  • Frequency of intraoperative hypotension [Срок оценки: Intraoperative period]
  • Total intraoperative vasopressor dose [Срок оценки: Intraoperative period]

Критерии участия

Критерии включения

  • Female patients aged 18-45 years
  • ASA physical status II
  • Scheduled for elective cesarean section under spinal anesthesia
  • Provision of written informed consent

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Niğde Ömer Halisdemir University Hospital — Niğde

Идентификаторы

NCT: NCT07440667 · 2025/154

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗