CTRI/2024/02/063307尚未招募Phase 3 4
Magnesium Sulphate As Adjuvant To Standard Therapy In Acute Organophosphorus Compound Poisoning : A Randomized Controlled Trial
JLN Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月10日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To study the efficacy of magnesium sulphate as adjuvant to the standard therapy (Atropine and oximes) in reducing morbidity and mortality.
研究概览
简要总结
In this study, we will study and compare the morbidity and mortality associated with standard therapy (Atropine and oximes) versus addition of magnesium sulphate as adjuvant to the standard therapy (Atropine and oximes) in acute organophosphorus compound poisoning.
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients arriving in the emergency OPD with history of OPC consumption and clinical features of cholinergic toxidrome of typical organophosphorus compound poisoning.
排除标准
- •Doubtful history Poisoning with unknown compound Treatment initiated before admission Patient refusal to consent Patient sensitive /allergic to any of the study drugs.
- •Cardiovascular disease patients(1-and2-degree heartblock) Severe hepatic and renal disease.
- •History of epilepsy or bleeding tendencies.
结局指标
主要结局
To study the efficacy of magnesium sulphate as adjuvant to the standard therapy (Atropine and oximes) in reducing morbidity and mortality.
时间窗: zero time at time of admission | 15 min. | 30 min. | 45 min. | 1 hour | 1.5 hour | 2 hour | 4 hour | 6 hour | 8 hour | 12 hour | 16 hour | 20 hour | 24 hour
次要结局
- To assess the requirement of atropine.(To compare the need for intubation and ventilation and ICU Stay.)
研究者
Dr Naveen Singh
J.L.N. Medical College Ajmer
研究点 (1)
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