跳至主要内容
临床试验/CTRI/2025/08/093824
CTRI/2025/08/093824尚未招募4 期

Comparative evaluation of total intravenous anaesthesia (TIVA) vs inhalational general anaesthesia on postoperative respiratory adverse events in children exposed to air pollutants: A randomised controlled study.

Maulana Azad Medical College1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年9月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
70
试验地点
1
主要终点
Incidence of postoperative respiratory adverse events (PRAEs) in patients exposed to air

研究概览

简要总结

We hypothesized that children exposed

to air pollutants receiving general anaesthesia with TIVA will have decreased risk of

postoperative respiratory adverse events as compared to children receiving inhalational

anaesthesia.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant and Investigator Blinded

入排标准

年龄范围
1.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • ASA I II or III Resident of Delhi NCR for at least 1 year Duration of surgery 1 to 4 hours.

排除标准

  • History of respiratory airway diseases (example asthma, bronchopulmonary dysplasia, cystic fibrosis) Recent (less than 2 weeks) upper or lower respiratory tract infections.
  • Neuromuscular disorders, congenital heart diseases Airway, chest, supraumbilical surgeries.
  • Known hypersensitivity or contraindications to propofol or inhalational anaesthetic agents.

结局指标

主要结局

Incidence of postoperative respiratory adverse events (PRAEs) in patients exposed to air

时间窗: Immediately after extubation, till 2 hours after surgery (at half-hour interval) and on ostoperative day 3

pollutants immediately after extubation in TIVA and Inhalational group.

时间窗: Immediately after extubation, till 2 hours after surgery (at half-hour interval) and on ostoperative day 3

次要结局

  • 1.Postoperative respiratory adverse events in patients exposed to air pollutants (PM2.5 &(PM10) at Post Operative Day 3.)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Ananya Panigrahi

Maulana Azad Medical College, New Delhi

研究点 (1)

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