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临床试验/NCT03355534
NCT03355534已完成不适用

Effect of Dexmedetomidine on Maintenance and Recovery of Cranial Aneurysm Surgery

Zhihong LU1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2018年1月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
incidence of coughing

研究概览

简要总结

Dexmedetomidine induces analgesic and sedative effects and is reported to decrease agitation during emergence after general anesthesia in various surgeries. For patients undergoing cranial aneurysm surgeries, a calm anesthesia and emergence is important. In this study, the investigatorstend to observe the effect of dexmedetomidine on maintenance and recovery of patients undergoing cranial aneurysm surgeries.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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 cerebral aneurysm embolism under general anesthesia

排除标准

  • patients with bradycardia or atrioventricular heart block
  • patients with ASA(American Society of Anesthesiologists) status over 3
  • patients with body mass index(BMI)≥30kg/m2
  • patients with difficulty in communication
  • patients with ruptured aneurysm
  • patients suspected or proved to be pregnant

研究组 & 干预措施

nasal dexmedetomidine

Experimental

dexmedetomidine is given nasally, saline is given intravenously

干预措施: nasal dexmedetomidine (Drug)

nasal dexmedetomidine

Experimental

dexmedetomidine is given nasally, saline is given intravenously

干预措施: intravenous saline (Drug)

intravenous dexmedetomidine

Experimental

saline is given nasally, dexmedetomidine is given intravenously

干预措施: Intravenous dexmedetomidine (Drug)

intravenous dexmedetomidine

Experimental

saline is given nasally, dexmedetomidine is given intravenously

干预措施: nasal saline (Drug)

normal saline

Placebo Comparator

saline is given nasally and intravenously

干预措施: intravenous saline (Drug)

normal saline

Placebo Comparator

saline is given nasally and intravenously

干预措施: nasal saline (Drug)

结局指标

主要结局

incidence of coughing

时间窗: from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes

次要结局

  • time to response to verbal command(from end of infusing anesthetics to response to verbal command,averagely 20 minutes)
  • Mini-mental state examination score(24 hours after surgery)
  • blood glucose before and after aneurysm embolism(immediately before inserting coil and after finishing inserting coil,an average of 1 hour)
  • score of coughing(from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes)
  • blood pressure before and after extubation(from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes)
  • blood lactate before and after aneurysm embolism(immediately before inserting coil and after finishing inserting coil,,an average of 1 hour)
  • Ricker's agitation-sedation score(from end of infusing anesthetics to 2 minutes after extubation, averagely 30 minutes)
  • time to extubation(from end of infusing anesthetics to extubation,averagely 28 minutes)

研究者

发起方
Zhihong LU
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zhihong LU

clinical professor

Air Force Military Medical University, China

研究点 (1)

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