跳至主要内容
临床试验/NCT03746340
NCT03746340Unknown不适用

The Effects of Different General Anesthetics on Serum Folic Acid and Homocysteine Concentrations in Children

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年11月7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
发起方
入组人数
40
试验地点
1
主要终点
levels of homocysteine in the perioperative serum

研究概览

简要总结

The concentration of folic acid and homocysteine in the blood can be used as independent risk factors for a variety of diseases. A sustained decrease in blood folate concentration and an increase in homocysteine concentration can damage vascular endothelial cells, causing varying degrees of neurodevelopmental abnormalities. Many clinical studies have found that anesthetics can affect blood folate and homocysteine concentration, but the effects of sevoflurane and propofol on blood folate and homocysteine concentrations are not clear. Therefore, this study aims to investigate the effects of sevoflurane and propofol on blood folate and homocysteine levels in children.

详细描述

Retrospective study: Study the medical history of infants and young children (less than 3 years old) who underwent sevoflurane or propofol general anesthesia for more than 3 hours from January 2018 to December 2018, and compare the preoperative and postoperative serum folate changes for retrospective analysis.

Prospective study:Ten infants and young children (less than 3 years old) who underwent general anesthesia from November 7, 2018 to December 31, 2018 in Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine. Inhalation of 1-8% concentration of sevoflurane for general anesthesia induced intubation, followed by sevoflurane 2.0 ~ 2.5 Vol% inhalation maintenance, according to the intraoperative situation to add opioids. Patients maintained a bispectral index (BIS) monitoring between 50 and 60. After induction of general anesthesia in all patients, Serum folate levels were measured before the start of surgery, every 1 hour during surgery, and at the end of surgery.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
1 Year 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children under 3 years old who underwent general anesthesia
  • Those who did not participate in other clinical trials within 3 months
  • No acute infectious diseases, systemic diseases
  • The family member of the child agrees to the test and signs the informed consent form.

排除标准

  • Refusal to join the group
  • severe liver and kidney damage
  • Hemodynamic instability (shock, blood pressure drop > 30% of basal blood pressure)
  • Children with egg and milk allergy
  • Children with a family history of malignant hyperthermia

研究组 & 干预措施

Anesthetic

Sevoflurane Group Propofol Group

干预措施: Propofol (Drug)

Anesthetic

Sevoflurane Group Propofol Group

干预措施: Sevoflurane (Drug)

结局指标

主要结局

levels of homocysteine in the perioperative serum

时间窗: Change of serum homocysteine levels from the beginning of anesthesia to the end.Serum homocysteine levels were measured at admission, after 1 hours,after 2 hours,after 3 hours.

Serum Hcy concentrations were analyzed by fluorescence polarization immunoassay using the IMx Homocysteine Reagent Pack and IMx Analyzer (Abbott Laboratories).

levels of folate in the perioperative serum

时间窗: Change of serum folate levels from the beginning of anesthesia to the end.Serum folate levels were measured at admission, after 1 hours,after 2 hours,after 3 hours.

a Chemiluminescent Microparticle Folate Binding Protein assay with the ARCHITECT Folate Reagent Kit (Abbott Laboratories, IL, USA) was used to determine serum folate concentrations. Serum folate concentrations were quantified using the ARCHITECT i2000 SR System (Abbott Laboratories).

次要结局

未报告次要终点

研究者

发起方
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验