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临床试验/NCT06236217
NCT06236217已完成不适用

Prediction of Spinal Anesthesia-Induced Hypotension in Cesarian Section: Carotid Artery-Corrected Flow Time Versus Cardiometry: Randomized Controlled Trial

Tanta University2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
2
主要终点
The incidence of post-spinal hypotension

研究概览

简要总结

This research aimed to evaluate and compare the role of carotid corrected flow time (FTc) and electrical cardiometry (EC) in the prediction and prevention of post-spinal hypotension in elective cesarian section.

详细描述

Spinal anesthesia is the procedure of choice for elective cesarean section (CS) because it avoids the most common side effects related to general anesthesia, such as the risk of aspiration, airway problems and the negative effects of intravenous anesthetic drugs on the fetus.

Accurate prediction of post-spinal hypotension could enhance clinical decision-making, optimize management, and facilitate early intervention. More than thirty predictors were used in the prediction of post-spinal hypotension including demographic data, hemodynamic variables, postural stress testing, peripheral perfusion indices, volume and fluid responsiveness indices, and genetic polymorphism.

The baseline parameters obtained via the bioreactance-based system may serve as a predictor of post-spinal anesthesia hypotension in parturient.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Aged ≥ 18 years.
  • American Society of Anesthesiologists (ASA) physical status II.
  • Gestational age (GA) ≥ 36 weeks.
  • Women planned elective cesarean section under spinal anesthesia.

排除标准

  • Patient refusal to participate in the study.
  • Gestational age of < 36 or ≥40 weeks of pregnancy.
  • Pregnancy-induced hypertension.
  • Diabetes.
  • Cardiovascular diseases, arrhythmia.
  • Antepartum hemorrhage.
  • Body Mass Index (BMI) above 36 kg/m
  • Clinical fetal complications.

结局指标

主要结局

The incidence of post-spinal hypotension

时间窗: Intraoperatively

Incidence of spinal anesthesia-induced hypotension was measured. Post spinal hypotension is defined as a drop in the SBP to less than 80mmHg, or less than 75% of the pre-anesthetic value. Hypotension was treated by IV vasopressor boluses (Ephedrine 5 mg).

次要结局

  • Complications(Intraoperatively)
  • The amount of vasopressor(Intraoperatively)
  • The amount of intravenous fluids(Intraoperatively)
  • Umbilical cord PH(Immediately after fetal delivery)
  • Neonatal APGAR score(5 minutes after fetal delivery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mostafa Mahmoud Shehab

Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Tanta University

研究点 (2)

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