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临床试验/NCT01768377
NCT01768377Unknown3 期

Comparison of in Intubation With Nerve Block and Intubation With Sedation in Awake Patients in Terms of Efficacy, Complications and Physician's Satisfaction

Tehran University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2012年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
70
试验地点
1
主要终点
Time required for intubation in seconds

研究概览

简要总结

The purpose of this study is to compare intubation with nerve block with intubation with sedation in awake patients in terms of efficacy, ease, and the rate of complications and physician satisfaction

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Candidate for intubation with methods other than RSI
  • Age>= 18 years
  • Patient or patient's guardian's consent

排除标准

  • Need for RSI or crash intubation
  • Allergy to Lidocain in block group
  • Allergy to opioid drugs in sedation group
  • Allergy to midazolam in either group

研究组 & 干预措施

Intubation with sedation

Active Comparator

Sedation with midazolam and analgesia with fentanyl

干预措施: Fentanyl (Drug)

Intubation with sedation

Active Comparator

Sedation with midazolam and analgesia with fentanyl

干预措施: Midazolam (Drug)

Intubation with Nerve block

Experimental

Laryngeal plus supraglottic plus intratracheal nerve block plus sedation with midazolam

干预措施: Nerve block with Lidocain (Drug)

Intubation with Nerve block

Experimental

Laryngeal plus supraglottic plus intratracheal nerve block plus sedation with midazolam

干预措施: Midazolam (Drug)

结局指标

主要结局

Time required for intubation in seconds

时间窗: From start of the intubation attempt for an average of one minutes

The interval is measured from the time that the healthcare provider attempts intubation until a successful intubation is achieved.

次要结局

  • physicians' perception of the difficulty of the procedure(Within an average of 30 minutes after completion of the procedure)
  • Number of Participants with Adverse Events(From the start of the procedure until 30 minutes after the procedure is completed)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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