跳至主要内容
临床试验/CTRI/2025/12/099180
CTRI/2025/12/099180尚未招募4 期

Effect of magnesium sulphate on emergence delirium in pediatric patient undergoing infraumbilical surgery: a double blinded randomized controlled trial

All India Institute of Medical Sciences Patna1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
72
试验地点
1
主要终点
To assess the effects of Magnesium Sulphate on the incidence of emergence

研究概览

简要总结

Magnesium sulphate, an NMDA receptor antagonist, possesses sedative, analgesic, and anti-agitation properties. Emergence delirium (ED) is a common postoperative complication in children receiving sevoflurane anaesthesia, especially after infraumbilical surgeries, leading to agitation, restlessness, and risk of injury. Current management often relies on opioids and sedatives, which increase side effects. Pre-emptive intravenous magnesium sulphate may reduce the incidence and severity of ED, decrease analgesic requirements, and improve recovery profiles in children.

研究设计

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

入排标准

年龄范围
2.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • 1.Paediatric patient age 2-8 years
  • Patient scheduled for elective infraumbilical surgeries
  • ASA I and II.

排除标准

  • 1.History of hypersensitivity
  • Neurological disorders, developmental delay, or psychiatric illness
  • pre-existing electrolyte imbalance
  • cardiac conduction abnormalities
  • Neuromuscular disease pulmonary, hepatobiliary or renal disease..

结局指标

主要结局

To assess the effects of Magnesium Sulphate on the incidence of emergence

时间窗: Just before induction till postoperative period of 60 minutes

delirium in pediatric patients undergoing elective infraumbilical surgery using PAED score

时间窗: Just before induction till postoperative period of 60 minutes

次要结局

  • 1.To assess severity of emergence delirium using PAED score.(2. To assess and evaluate post operative pain score using FLACC score.)

研究者

发起方
All India Institute of Medical Sciences Patna
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Tanveer Singh Aulakh

AIIMS PATNA

研究点 (1)

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