NCT01923831已完成不适用
Comparison of the Effect of Magnesium Sulfate and Dexamethasone on Postoperative Sore Throat After Spinal Surgery in Prone Position With Tracheal Intubation: a Double-blind, Randomized, Noninferiority Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- The effect of magnesium sulfate on postoperative sore throat after spinal surgery in prone position with tracheal intubation
研究概览
简要总结
The purpose of this study is to compare the effect of magnesium sulfate and dexamethasone on postoperative sore throat after spinal surgery in prone position with tracheal intubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I-II patients aged between 20 and 65 year undergoing 1 or 2 level posterior spinal fusion in prone position with tracheal intubation
排除标准
- •preexisting hoarseness or sore throat, upper respiratory tract infection
- •steroid therapy or immunocompromised patients
- •chronic treatment with calcium channel blocker or magnesium
- •allergy to magnesium sulphate
- •Cormack-Lehane grade 3,4 or patients who are expected to difficult intubation
- •fail to tracheal intubation at first trial
- •reduced kidney function
- •Diabetes mellitus
研究组 & 干预措施
Magnesium group
Experimental
干预措施: Magnesium Sulfate (Drug)
Dexamethasone group
Active Comparator
干预措施: dexamethasone (Drug)
结局指标
主要结局
The effect of magnesium sulfate on postoperative sore throat after spinal surgery in prone position with tracheal intubation
时间窗: Change of post operative sore throat level from 1 to 48 hours after surgery
Incidence of post operative sore throat Severity of post operative sore throat (10 cm-visual analogue scale ) Incidence of post operative hoarseness Severity of post operative hoarseness ( four-graded scale, 0= no hoarseness, 1= mild hoarseness, 2= severe hoarseness, 3= aphonia)
次要结局
- The effect of dexamethasone on postoperative sore throat after spinal surgery in prone position with tracheal intubation(Change of post operative sore throat level from 1 to 48 hours after surgery)
研究者
研究点 (1)
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