Effects of Propofol and Sevoflurane on Blood Folic Acid and Homocysteine Concentrations in Children With Cochlear Implant Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Serum folate levels
研究概览
简要总结
To investigate the effect of sevoflurane and propofol on the concentrations of serum homocysteine and folic acid in children who received cochlear implant surgery.
详细描述
This study is a prospective single center, cross-reference clinical application study.This study plan to enroll 40 children with cochlear implant surgery. Children were selected randomly and divided into 2 groups.Each group has 20 patients. All children undergo orotracheal intubation, mechanical ventilation will given by anaesthetic machine (U.S. Ohmeda advance cs2 ) to maintain oxygen saturation above 95%, hemodynamics and other vital signs were monitored with the anesthesia monitor.In the operation room,2-3ml arterial blood will be taken.And the levels of homocysteine and folic acid will be measured at week 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children accepted cochlear implant surgery under general anesthesia
- •no participate in any other trial up to 3 months before this study
- •no acute infectious diseases, systemic diseases
- •willing to participate in this study and sign the informed consent
排除标准
- •unwilling to participate in this study
- •with a history of serious liver or kidney dysfunction
- •hemodynamic instability (etc. shock, blood pressure reduced by 30%)
- •children with egg milk allergy
- •children with a family history of malignant hyperthermia
研究组 & 干预措施
Group S
Children aged 1 month to 3 years who were scheduled to undergo cochlear implant surgery under general anesthesia were enrolled in this study.Children were treated with an infusion bolus of 2.0mg/kg propofol during anesthesia induction and maintained with 2.0-2.5vol% sevoflurane, with the dosage adjusted to achieve loss of consciousness.The bispectral index of EEG was maintained between 50 and 60 in all groups.The homocysteine and folic acid concentrations were measured after anesthesia induction and at the end of surgery separately .
干预措施: Sevoflurane (Drug)
Group P
Children aged 1 month to 3 years who were scheduled to undergo cochlear implant surgery under general anesthesia were enrolled in this study.Children were treated with an infusion bolus of 2.0mg/kg propofol during anesthesia induction and continuous infusion of 7 to 8mg/kg/hour, with the dosage adjusted to achieve loss of consciousness.The bispectral index of EEG was maintained between 50 and 60 in all groups.The homocysteine and folic acid concentrations were measured after anesthesia induction and at the end of surgery separately .
干预措施: Propofol (Drug)
结局指标
主要结局
Serum folate levels
时间窗: Measured at Week 1
The serum folate concentration was detected by microparticle enzyme immunoassay.
次要结局
- Plasma homocysteine levels(Measured at Week 1)
研究者
Jingjie Li
vice-director
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University