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.
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
Dr Ananya Panigrahi
Maulana Azad Medical College, New Delhi
研究点 (1)
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