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临床试验/NCT02284672
NCT02284672已完成4 期

The Effect of Dexmedetomidine on Propofol Requirement for Insertion of Laryngeal Mask Airway

Ajou University School of Medicine1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2014年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
39
试验地点
1
主要终点
Fail or success for Laryngeal Mask Airway (LMA) insertion

研究概览

简要总结

Propofol frequently used as an inducting medication for insertion Laryngeal mask airway(LMA). But propofol alone can be not sufficient for inhibiting upper airway reflex and also result in cardiovascular suppression under enough amount. Dexmedetomidine is a selective alplh2 receptor agonist with analgesic and sedative effects but sparing respiratory function. Therefore propofol combined with dexmedetomidine induction could be more effective in preserve respiration under same condition for LMA insertion than propofol alone. In this study, the investigators investigate the clinical dose of propofol for LMA insertion with premedication of dexmedetomidine, and evaluate the effect of dexmedetomidine.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double (Participant, Investigator)

入排标准

年龄范围
19 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patients for surgery not exceed more than 2 hours requiring general anesthesia

排除标准

  • history of gastroesophageal reflux High grade obesity Predicted diffiicult airway

研究组 & 干预措施

control

Placebo Comparator

After preoxygenation for 3 minutes, normal saline would be injected to patient for 10 minute. First, 1% lidocaine 3 ml were given for reducing injection pain of propofol and the settled amount of propofol was injected during 15 seconds.

After 90 seconds, other anesthesiologist who did'nt know the injected drug tried to insert LMA.

干预措施: Normal saline (Drug)

dexmedetomidine

Experimental

After preoxygenation for 3 minutes, dexmedetomidine would be injected to patient for 10 minute. First, 1% lidocaine 3 ml were given for reducing injection pain of propofol and the settled amount of propofol was injected during 15 seconds.

After 90 seconds, other anesthesiologist who did'nt know the injected drug tried to insert LMA.

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

Fail or success for Laryngeal Mask Airway (LMA) insertion

时间窗: During inserting LMA and up to 5 seconds after LMA inserion

Failure for LMA insertion is defined if there is a difficulty for mouth opening or active movement of four limbs or head. Success is smooth LMA insertion without any movement

次要结局

未报告次要终点

研究者

发起方
Ajou University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jiyoung Yoo

clinical assistant professor

Ajou University School of Medicine

研究点 (1)

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