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Comparison of the Manually Controlled Propofol Infusion and Target Controlled Infusion in Children

2022年1月25日 更新者:Irina Milojevic、University Children's Hospital

Comparison of the Manually Controlled Propofol Infusion and Target Controlled Infusion Anesthesia for One Day Surgery in Pediatric Patients

Patients 1 to 8 years of age, American Society of Anesthesiologist score 1 and 2, planned for elective, one day surgery: inguinal hernia repair, hydrocele surgery, testis retention surgery, varicocele and phimosis surgery, and parents or legal guardians will be asked to sign written informed consent for participation in the study. Exclusion criteria will be: confirmed propofol allergies, mitochondrial disease, disease of lipid and carbohydrate metabolism, neurological disorders, treated psychiatric comorbidities, hypertension.

All participants will be randomly assigned to two groups: one in which manually controlled propofol infusion will be used (MC group) and the other with target controlled infusion (TC group). After anesthesia induction depth of anesthesia during surgery will be measured using bispectral index (BIS), continuously. As a part of routine monitoring noninvasive blood pressure monitoring will be measured, and recorded in three time points, as well as heart rate. Time will be measured from the moment when propofol infusion was stopped till tracheal extubating.

研究概览

详细说明

Prospective, randomized controlled study will be done at the University Children's Clinic. For the study ethical board approval was requested. Pediatric patients, planned for elective, one day surgery, requiring intubation with signed informed consent will be randomly assigned to two groups First in which manually controlled propofol infusion will be used (MC group) and the other with target controlled infusion (TC group).

All participants will be premedicated half an hour before anesthesia induction with midazolam orally in dose of 0.5mg/kg body weight. Intravenous cannula will be placed 20-30 minutes later, and participants will receive atropine in dose of 0,02mg/kg intravenously, and fentanyl 1mcg/kg intravenously. In the MC group participants will receive propofol bolus 2.5-3 mg/kg, for anesthesia induction and anesthesia maintenance will be done according to the Mc Farlan scheme. In TC group Pedfusor model will be used, with target concentration for anesthesia induction of 4 mcg/kg body weight and anesthesia maintenance of 3 mcg/kg. In all participants remifentanil in dose of 0.4mcg/kg/min will be used as analgesic, and cisatracurium 0.15mg/kg was muscle relaxant, for anesthesia induction. At the end of surgery, before remifentanil infusion is stopped, all patients will receive 0.5 mg/kg of ketorolac. If BIS values are out of the40-60 range during anesthesia, in MC group infusion rate will be changed and in TC group set plasma concentration (Cp) will be corrected. In case of heart rate increase or decrease for more than 20% compared to initial values, speed of remifentanil infusion will be decreased or increased, respectively. All participants will have standard monitoring during anesthesia: percutaneous saturation, end tidal concentration of carbon dioxide measurement, three channel electrocardiography, noninvasive blood pressure monitoring, and continuous BIS measurement. Propofol infusion will be stopped 5 minutes before expected end of surgery, and remifentanil infusion will be stopped at the end of surgery. Time will be measured from the moment when propofol infusion was stopped till tracheal extubating.

研究类型

介入性

注册 (实际的)

61

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Belgrade、塞尔维亚、11000
        • University Children's Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

1年 至 8年 (孩子)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • ASA score 1 and 2.
  • Planned for elective, one day surgery: inguinal hernia repair, hydrocele surgery, testis retention surgery, varicocele and phimosis surgery,
  • Signed written informed consent for participation in the study by parent and/or legal guardian.

Exclusion Criteria:

  • Confirmed propofol allergies.
  • Mitochondrial disease
  • Disease of lipid and carbohydrate metabolism
  • Neurological disorders
  • Treated psychiatric comorbidities
  • Hypertension.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Manually controlled
Patients will receive propofol bolus 2.5-3 mg/kg, for anesthesia induction and anesthesia maintenance was continued according to the Mc Farlan scheme, meaning continuous propofol infusion is used, with gradual reduction of the infusion speed in timely manner, depending on the duration of surgery: 15mg/kg/h...13mg/kg/h...11mg/kg/h...9mg/kg/h...6mg/kg/h.
实验性的:Target controlled
Pedfusor model was used for delivering target controlled plasma concentration, with target concentration for anesthesia induction of 4 mcg/kg body weight and then 3 mcg/kg.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Depth of anesthesia comparison between two experimental groups.
大体时间:From anesthesia induction till extubation, every minute up to 90 minutes.
Depth of anesthesia will be measured with continuous bispectral index and compared between two experimental groups.
From anesthesia induction till extubation, every minute up to 90 minutes.

次要结果测量

结果测量
措施说明
大体时间
Comparison of blood pressure between two experimental groups.
大体时间:At 0 and 20 minutes during anesthesia and 5 minutes after discontinuation of propofol infusion.
Blood pressure will be measured in three specified time points during anesthesia, and the values will be compared between two experimental groups.
At 0 and 20 minutes during anesthesia and 5 minutes after discontinuation of propofol infusion.
Comparison of heart rate between two experimental groups.
大体时间:At 0 and 20 minutes during anesthesia and 5 minutes after discontinuation of propofol infusion.
Heart rate will be measured in three specified time points during anesthesia, and the values will be compared between two experimental groups.
At 0 and 20 minutes during anesthesia and 5 minutes after discontinuation of propofol infusion.
Time to tracheal extubation comparison between two experimental groups.
大体时间:5 to 15 minutes after discontinuation of propofol infusion
Time to tracheal extubation will be measured after propofol infusion termination in both experimental groups and compared.
5 to 15 minutes after discontinuation of propofol infusion

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年10月18日

初级完成 (实际的)

2022年1月17日

研究完成 (实际的)

2022年1月24日

研究注册日期

首次提交

2021年8月10日

首先提交符合 QC 标准的

2021年10月4日

首次发布 (实际的)

2021年10月18日

研究记录更新

最后更新发布 (实际的)

2022年1月26日

上次提交的符合 QC 标准的更新

2022年1月25日

最后验证

2022年1月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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