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临床试验/NCT01614535
NCT01614535已完成不适用

Comparison of the Effect Site Concentration of Remifentanil for Preventing Cough During Emergence Between Male and Female Patients With Thyroidectomy

Yonsei University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2011年8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
46
试验地点
1
主要终点
occurrence of cough

研究概览

简要总结

The clinical studies demonstrate more powerful analgesic effect among female to both μ- and κ-opioid agonist (Fillingim et al. 2004). The antitussive effect of opioid is mediated predominantly by μ-, κ-opioid receptors (Kamei J. 1996). Therefore, the investigators hypothesized that there are sex differences in the antitussive responses to opioid.

It has been reported that target-controlled infusion (TCI) of remifentanil can reduce cough against endotracheal tube during emergence from general anesthesia. Some studies, reporting the EC50 and EC95 of remifentanil in effect-site TCI for preventing cough during emergence in different sex and surgeries (B. Lee et al. 2009, E.M.Choi et al. 2012), showed differences in EC50 and EC95.

The purpose of this study was to find out EC50 and EC95 of remifentanil in effect-site TCI for preventing cough during emergence in each sex and to evaluate whether there were sex differences in EC50 and EC95 of remifentanil in effect-site TCI or not.

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
Single (Outcomes Assessor)

入排标准

年龄范围
25 Years 至 46 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • aged 20-46
  • ASA classification I~II
  • patients undergoing thyroidectomy

排除标准

  • patient who has signs of a difficult airway
  • patient who has smoking history
  • patient who has upper respiratory infection or sore throat in the previous two weeks
  • patient who has hypertension, DM
  • female patients who were pregnant, breast-feeding or menopausal

研究组 & 干预措施

Female group

Experimental

Female gender patients undergoing thyroidectomy

干预措施: up-and-down method to find out effective concentration of remifentanil for preventing cough during emergence (Drug)

Male group

Active Comparator

Male gender patients undergoing thyroidectomy

干预措施: up-and-down method to find out effective concentration of remifentanil for preventing cough during emergence (Drug)

结局指标

主要结局

occurrence of cough

时间窗: 20 minutes after sevoflurane off

The cough was defined as a sudden contraction of the abdomen. The level 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 sec with moderate severity; Grade 3, severe, persistent cough for more than 5 sec. The patients will be followed from Sevolurane off to being transported to PACU.

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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