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临床试验/NCT06694675
NCT06694675已完成不适用

An Observational Study on the Effect of Sevoflurane on Airway Hyperreactivity in Children with RSV Infection During the Perioperative Period.

First Hospital of China Medical University2 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2022年2月1日最近更新:
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
97
试验地点
2
主要终点
Intraoperative ventilator parameters

研究概览

简要总结

To investigate the effects of sevoflurane on respiratory parameters and respiratory inflammation in healthy and RSV-infected under general anesthesia and to propose suitable perioperative airway protection measures for children with respiratory virus infection undergoing general anesthesia.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
2 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients voluntarily joined this study and signed an informed consent form;
  • Age: 2-5 years old;
  • The patient should have a good general condition and no serious internal medicine comorbidities (ASA classification of the American Anesthesiology Association is Grade I); BMI ≤ 20;
  • Plan to undergo elective adenoidectomy or adenotonsillectomy with tracheal intubation.

排除标准

  • Children with a history of allergic asthma;
  • Children with space-occupying lesions of the chest and lungs, or acute bronchiolitis or pneumonia;
  • Children with cardiovascular diseases that may cause cough, wheezing, and other symptoms;
  • Children who used leukotriene modulators, β2 receptor agonists, anticholinergics, theophyllines, or hormonal treatment drugs within two weeks;
  • Children allergic to propofol, sevoflurane, or other anesthetic agents;
  • Children with a family history of malignant hyperthermia;
  • Children with liver and kidney dysfunction;
  • The result of rapid antigen detection and nucleic acid test for RSV was inconsistent, or children combined with pathogen infections other than RSV;
  • Children with fever.

研究组 & 干预措施

Control group

The nasopharyngeal swab test for RSV antigen was negative for patients with no history of respiratory infection in the past six weeks before surgery.

干预措施: Sevoflurane (Volatile Anesthetic) (Drug)

Control group

The nasopharyngeal swab test for RSV antigen was negative for patients with no history of respiratory infection in the past six weeks before surgery.

干预措施: propofol (Drug)

RSV group

The nasopharyngeal swab of the RSV antigen test is positive.

干预措施: Sevoflurane (Volatile Anesthetic) (Drug)

RSV group

The nasopharyngeal swab of the RSV antigen test is positive.

干预措施: propofol (Drug)

结局指标

主要结局

Intraoperative ventilator parameters

时间窗: After induction of general anesthesia and intubation; at the end of anesthesia

Airway pressure(including Paw, PIP, Pplat), and pulmonary compliance.

次要结局

  • Inflammation response indications(After induction of general anesthesia and intubation; at the end of anesthesia)

研究者

发起方
First Hospital of China Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Liu Weiwei

associate professor of anesthesiology department

First Hospital of China Medical University

研究点 (2)

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