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临床试验/CTRI/2021/03/031859
CTRI/2021/03/031859招募中不适用

Post-operative vomiting after paediatric strabismus surgery: a comparison of propofol versus sevoflurane anaesthesia

Narayana Nethralaya1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年12月3日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
70
试验地点
1
主要终点
1.The primary outcome is to compare the incidence of postoperative vomiting in children undergoing strabismus surgery under intravenous versus balanced anaesthesia

研究概览

简要总结

Post-operative nausea and vomiting (PONV) is a significant problem after strabismus surgery. In the absence of any prophylaxis, the incidence of post-opeartive vomiting is 40-60%. Several factors including duration of surgery, use of volatile anaesthetic agents and nitrous oxide for maintenance of anaesthesia, use of opioids for analgesia in the post-opeartive period as well as history of motion sickness or PONV in the child have all been reported to be risk factors. Children belowtwelve years need general anaesthesia for squint surgery to ensure immobility and pain relief. Among the anaesthetic agents, use of inhalational agents(isoflurane, sevoflurane, desflurane, nitrous oxide) have all been implicated in increasing the risk of PONV. In TIVA(totally intravenous anaesthesia) technique, oxygen and are the only gases used and anaesthesia is maintained using an infusion of propofol. This technique has been found to reduce e PONV in other types of surgery . The primary outcome is to compare the incidence of postoperative vomiting in children undergoing strabismus surgery under intravenous versus balanced anaesthesia. The secondary outcome is to compare the incidence of emergence agitation in the two groups. This study is unique in being the first to compare sevoflurane (without nitrous oxide)and propofol  as agents for maintenance of anaesthesia  in squint surgery in children aged 1-12 years. 70 children will be randomized into one of the two groups S or P w, in whom anaesthesia will be maintained using sevoflurane balanced anesthesia or TIVA with propofol respectively. They will be intubated after administration of injection fentanyl 2 µg/kg and atracurium 0.5mg/kg. Both groups will receive ondansetron 0.1mg/kg, dexamethasone 0.1mg/kg intravenously as anti-emetic prophylaxis and paracetamol 15mg/kg intravenously for post-operative analgesia. The intra-operative hemodynamics  like heart rate, blood pressure, total dose of Fentanyl and atracurium as well as the duration of surgery and anaesthesia will be noted. At the end of surgery, the child will be monitored in the post anaesthesia care unit. The emergence delirium will be noted using a PAED (paediatric anaesthesia emergence delirium) score. Any episode of postoperative nausea or vomiting in the 0-2 hour, 2-6 hour and 6-24 hour period will be recorded. Retching is also considered as vomiting. Rescue antiemetic ondansetron 0.1 mg/kg will be administered if there is more than one episode of vomiting. The end point of the study is reached at 24 hour.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor 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

  • 70 consecutive ASA I-II children aged 1-12 years undergoing strabismus surgery under general anaesthesia will be recruited after obtaining written parental consent.

排除标准

  • Patients with a known allergy to propofol, those with a known difficult airway and those with a severe neurological disorder will be excluded from the study.

结局指标

主要结局

1.The primary outcome is to compare the incidence of postoperative vomiting in children undergoing strabismus surgery under intravenous versus balanced anaesthesia

时间窗: 0-2 hour, 2-6 hour and 6-24 hour

次要结局

  • 2.The secondary outcome is to compare the incidence of emergence agitation in the two groups(0-2 hour)

研究者

申办方类型
Private hospital/clinic

研究点 (1)

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