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临床试验/CTRI/2019/02/017716
CTRI/2019/02/017716已完成不适用

A comparative study between two doses of magnesium sulphate as sedative during awake fiberoptic intubation for patients undergoing maxillofacial surgeries: a randomized controlled trial.

IMS BHU1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年1月3日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Change in Ramsay Sedation Score

研究概览

简要总结

This study is a randomized, double blind, parallel group trial comparing the safety and efficacy of Magnesium sulphate 30 mg/kg and Magnesium sulphate 45 mg/kg in 80 patients with maxillofacial injuries undergoing awake fiberoptic laryngoscopy that will be conducted in India. The primary outcome measures will be Ramsay Sedation Score during fiberoptic laryngoscopy. The secondary outcomes will be hemodynamic changes during fiberoptic laryngoscopy

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • ASA Grade I and II.

排除标准

  • ASA Grade III and IV Allergy/Hypersensitivity to magnesium sulphate Cardiac arrhythmia/CHD/Cardiopulmonary disease Presence of cervical spine.

结局指标

主要结局

Change in Ramsay Sedation Score

时间窗: During awake fiberoptic laryngoscopy

次要结局

  • Changes in blood pressure and heart rate(During awake fiberoptic laryngoscopy)

研究者

发起方
IMS BHU
申办方类型
Research institution and hospital

研究点 (1)

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