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临床试验/NCT03126422
NCT03126422Unknown1 期

Effects of Different Doses of Dexmedetomidine on Fentanyl-induced Cough

Yangzhou University1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2017年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
发起方
入组人数
240
试验地点
1
主要终点
The incidence of cough

研究概览

简要总结

The investigators aimed to investigate the effects of pretreatment with different doses of dexmedetomidine on the cough caused by fentanyl during anesthetic induction.

Patients undergoing elective surgeries under general anesthesia will be randomly allocated to 4 groups (n = 60, each group). Dexmedetomidine 0, 0.03, 0.06, and 0.09 μg/kg/min will be pump-administered in 10 mins to groups I, II, III, and IV, respectively, followed by the induction of general anesthesia with intravenous fentanyl 4 μg/kg. The incidences and severity of cough that occurred within 2 min after the injection of fentanyl will be recorded, and the incidences of cardiovascular adverse events that occurred between the administration of the dexmedetomidine infusion and 2 min after tracheal intubation will be recorded.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing elective surgeries under general anesthesia.

排除标准

  • Patients with contraindications of dexmedetomidine.
  • Patients younger than 18 years old and older than 65 years old.

研究组 & 干预措施

Dexmedetomidine 0 μg/kg/min

Experimental

干预措施: Dexmedetomidine (Drug)

Dexmedetomidine 0.03 μg/kg/min

Experimental

干预措施: Dexmedetomidine (Drug)

Dexmedetomidine 0.06 μg/kg/min

Experimental

干预措施: Dexmedetomidine (Drug)

Dexmedetomidine 0.09 μg/kg/min

Experimental

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

The incidence of cough

时间窗: After the infusion of dexmedetomidine up to 10 minutes

Yes or No

The time of cough

时间窗: After the infusion of dexmedetomidine up to 10 minutes

After the infusion of dexmedetomidine up to 10 minutes

The severity of cough

时间窗: After the infusion of dexmedetomidine up to 10 minutes

minor, moderate, severe

The occurence of adverse effects of dexmedetomidine

时间窗: After the infusion of dexmedetomidine up to 10 minutes

bradycardia, hypotension, hypertension

次要结局

未报告次要终点

研究者

发起方
Yangzhou University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhuan Zhang

Director

Yangzhou University

研究点 (1)

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