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临床试验/NCT01291849
NCT01291849已完成4 期

The Effect-site Concentration of Remifentanil for Preventing Cough During Emergence From Balanced Anesthesia for Nasal Surgery

Yonsei University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2010年3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
入组人数
24
试验地点
1
主要终点
cough incidence

研究概览

简要总结

After nasal surgery, emergence cough or straining will produce venous engorgement and increase bleeding from the surgical site, so the necessity for smooth extubation without severe cough during emergence provides a challenge for the anesthetists. Recently, remifentanil is commonly used short-acting opioid, and several studies have demonstrated the antitussive effect of remifentanil via effect-site target-controlled infusion during emergence. However, there may be gender difference in response to opioid, and the previous studies about antitussive effect of remifentanil are targeted at female patients and there is no investigation of effect site concentration of remifentanil for male patients undergoing nasal surgery. The purpose of this study is to evaluate the effect-site concentration of remifentanil via target-controlled infusion for preventing cough in man after sevofluorane balanced anesthesia.

研究设计

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

入排标准

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

入选标准

  • all male aged 18-60 years
  • ASA(American Society of Anesthesiologists)physical status I or II
  • who underwent ESS(endoscopic sinus surgery)or septoplasty under sevoflurane-remifentanil balanced anesthesia

排除标准

  • predicted difficult airway,
  • BMI(Body Mass Index) of more than 30 kg/m2,
  • chronic respiratory disease,
  • recent respiratory track infection,
  • chronic coughing,
  • significant cardiovascular,
  • hepatic or renal disease,
  • current smokers
  • medical history of medication of opioid or ACEI(angiotensin covering enzyme inhibitor)

研究组 & 干预措施

remifentanil for intranasal surgery

Experimental

干预措施: Dixon up-and-down method (Drug)

结局指标

主要结局

cough incidence

时间窗: from sevoflurane discontinuation (at the end of anesthesia) to 5 min after extubation

Cough is defined as a strong and sudden contraction of the abdomen or forced exhalation movement.

cough grade

时间窗: from sevoflurane discontinuation (at the end of anesthesia) to 5 min after extubation

Cough occurrence and number are recorded according to the grading system as follow; Grade 0 - no cough Grade 1 - light (single) cough Grade 2 - moderate cough (more than 1 episode of non-sustained cough) Grade 3 - sustained and repetitive cough movement and head lift.

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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