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临床试验/NCT01617694
NCT01617694已完成不适用

Comparison Between Remifentanil Target-controlled Infusion and Dexmedetomidine Bolus Administration for Smooth Emergence From General Sevoflurane Anesthesia

Yonsei University1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2011年6月最近更新:
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
65
试验地点
1
主要终点
coughing response

研究概览

简要总结

Remifentanil target-controlled infusion and dexmedetomidine single-dose administration are known to reduce airway response and haemodynamic stimulation during anaesthetic recovery. The investigators will compare the effects of two drugs on prevention of cough during emergence from general sevoflurane anaesthesia.

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
Double (Participant, Investigator)

入排标准

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

入选标准

  • female patient,
  • aged 20-60 yr,
  • ASA physical status 1-2,
  • patients undergoing elective thyroidectomy under general anesthesia

排除标准

  • sighs of difficult airway,
  • history of respiratory disease or chronic cough,
  • cardiovascular disease,
  • pregnant or breast-feeding woman.

研究组 & 干预措施

group R

Experimental

continuation of remifentanil target controlled infusion (TCI) at effect-site concentration of 2 ng/ml during anesthetic recovery until extubation.

干预措施: dexmedetomidine (Drug)

group R

Experimental

continuation of remifentanil target controlled infusion (TCI) at effect-site concentration of 2 ng/ml during anesthetic recovery until extubation.

干预措施: Normal Saline (Drug)

group D

Active Comparator

remifentanil TCI discontinuation and dexmedetomidine 0.5 mg/kg intravenous injection before 10 min of the end of surgery

干预措施: dexmedetomidine (Drug)

group D

Active Comparator

remifentanil TCI discontinuation and dexmedetomidine 0.5 mg/kg intravenous injection before 10 min of the end of surgery

干预措施: Normal Saline (Drug)

结局指标

主要结局

coughing response

时间窗: from discontinuation of anesthetic agent (sevoflurane) to 5 min after extubation.

Emergence cough was defined as the cough occurrence during peri-extubation period, from sevoflurane discontinuation to 5 min after extubation. The severity of cough was assessed and recorded by the following cough grading system: Grade 0, no cough; Grade 1, single cough with mild severity; Grade 2, cough persistence less than 5 s with moderate severity; Grade 3, severe, persistent cough for more than 5 s (bucking).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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