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临床试验/NCT01924871
NCT01924871已完成4 期

Comparison of Deep Extubation During Emergence Using Desflurane or Desflurane With Remifentanil in Patients Undergoing General Anesthesia

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 62 人开始时间: 2013年7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
62
试验地点
1
主要终点
Awakening Time

研究概览

简要总结

It has been reported that deep extubation can reduce cardiopulmonary complication against endotracheal tube extubation during emergence from general anesthesia. The investigators hypothesized that using desflurane with target controlled infusion of remifentanil is more effective than using desflurane alone during deep extubation. The purpose of this study is to evaluate the effect of remifentanil to prevent respiratory complication (etc. coughing) during emergence from general anesthesia.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Age 20-60
  • patients undergoing elective surgery take more than an hour
  • Under general anesthesia using an LMA

排除标准

  • Patients on CNS depressants
  • Chronic opioid use
  • Corticosteroid
  • Pregnant patients
  • Full stomach
  • Morbidly obese (BMI >35kg/m2)
  • Hepatitis B
  • Hepatitis C
  • Coronary artery disease
  • Liver disease
  • Renal disease
  • Seizure disorder
  • Dropout criteria:
  • Need for reintubation due to breath holding
  • high ETCO2 during self ventilation (ETCO2>50)
  • Surgeon or patient request

研究组 & 干预措施

Desflurane group

Active Comparator

1.5 MAC desflurane until extubation

干预措施: Desflurane (Drug)

Desflurane with remifentanil group

Active Comparator

1.0 MAC desflurane with 1.0ng/ml targeted concentration infusion of remifentanil

干预措施: Desflurane with remifentanil (Drug)

结局指标

主要结局

Awakening Time

时间窗: Participants will be followed from the time of extubation in operating room to the time of discharge from recovery room, an expected average of 1day.

The outcomes assessor will record from the time of extubation in operating room to the time of eye opening and mouth opening

次要结局

  • Success Rate & Complication Rate Including Cough(assessing the success rate of deep extubation without complication and the occurrance of cough from the completion of surgery to 5minute after extubation.)

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, MD, Ph.D

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

研究点 (1)

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