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临床试验/NCT01878656
NCT01878656已完成4 期

Comparison of Emergence Agitation Between Sevoflurane and Desflurane Anesthesia After Orthognathic Surgery

Chung-Ang University Hosptial, Chung-Ang University College of Medicine1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2013年4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
144
试验地点
1
主要终点
The Incidence of Emergence Agitation Using Four-point Categorical Scale

研究概览

简要总结

Emergence agitation is a major concern in patients undergoing orthognathic surgery. The patients may experience the sense of suffocation during emergence due to nasotracheal intubation and orofacial edema. Postoperative pain is also associated with emergence agitation. Although there is a lot of studies about emergence agitation in children, there is a few in adults, furthermore, no data about comparison of emergence agitation between sevoflurane and desflurane anesthesia in adults. Therefore, the investigators would like to compare the incidence and severity of emergence agitation between sevoflurane and desflurane anesthesia in adults after orthognathic surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • American Society of Anesthesiologists(ASA) physical status classification 1 or 2 patients
  • patients scheduled for orthognathic surgery

排除标准

  • severe cardiopulmonary disease
  • psychological disease
  • patients who cannot understand Korean

研究组 & 干预措施

Desflurane

Active Comparator

administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia

干预措施: Desflurane (Drug)

Sevoflurane

Active Comparator

administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia

干预措施: Sevoflurane (Drug)

结局指标

主要结局

The Incidence of Emergence Agitation Using Four-point Categorical Scale

时间窗: Participants will be followed from the time of gas discontinuation in operating room to the time of discharge from postanesthesia care unit(PACU), an expected average of 1 hour.

The outcomes assessor will evaluate the severity of emergence agitation of participants using a four-point categorical scale. (1: calm, 2: not calm, but could be easily calmed, 3: moderately agitated or restless, 4: combative, excited, disoriented) We considered presence of emergence agitation as 3 and 4 of four-point scale.

次要结局

  • The Time to Extubation(Participants will be followed from the time of gas discontinuation in operating room to the time of discharge from postanesthesia care unit(PACU), an expected average of 1 hour.)

研究者

发起方
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chongwha Baek

Chongwha Baek, M.D., Ph.D.

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

研究点 (1)

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