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临床试验/NCT07035899
NCT07035899已完成不适用

Association of Maternal and Neonatal Umbilical Cord Blood Levels of Propofol Administered for Induction of General Anesthesia With Perinatal Findings in Gravidas Undergoing Cesarean Section

Haseki Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2023年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
102
试验地点
1
主要终点
Blood propofol concentration

研究概览

简要总结

The effects of intravenous propofol administration for general anesthesia in cesarean deliveries on maternal and infant health will be evaluated in relation to maternal and umbilical cord blood propofol levels.

详细描述

After the ethics committee approval was obtained, volunteers who met the criteria for inclusion in the study were included in the study after obtaining their written permission. After the patients were taken to the operating room, IV catheterization was achieved after CTA, TA and sPO2 monitoring, and the patient was intubated 2 minutes after induction of propfol at 3 mg/kg and rocuronium at 0.6 mg/kg. After the baby was born, an intravenous blood sample was taken from the umbilical cord and the mother simultaneously. After the venous blood samples were obtained as 3 μL, the serum samples obtained by centrifugation as standard were portioned in equal volume to 500 μL Eppendorf tubes and stored at -80°C. After this pre-treatment, propofol was subjected to measurement tests with HPLC, and the collected data were added

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Being pregnant in ASA category 1-2
  • •>39 weeks of healthy pregnancy
  • •>28 weeks complicated pregnancy
  • •Cesarean delivery with or without action
  • •Providing induction of general anesthesia with intravenous propofol

排除标准

  • •Pregnant women under the age of 18,
  • •Those who have stillbirth,
  • •Severe chronic kidney and liver disease,
  • •Neurological disease
  • •Those with other systemic diseases

研究组 & 干预措施

Women with Healthy Pregnance undergone Caesarean Section

Sham Comparator

Healthy Pregnant Women between the ages of 18 and 40

干预措施: Caesarean Section (Drug)

Women Compliceted Pregnance undergone Caesarean Section

Active Comparator

Pregnant women between the ages of 18-40 with Pearclampsia, Preterm Labor, Fetal Growth Retardation, Gestational Diabetes

干预措施: Caesarean Section (Drug)

结局指标

主要结局

Blood propofol concentration

时间窗: The first 5 minutes of cesarean delivery

ng/ml

次要结局

未报告次要终点

研究者

发起方
Haseki Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Emine Yilmaz Guler

Obstetric Anesthesia Specialist

Haseki Training and Research Hospital

研究点 (1)

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