NCT00553709终止2 期
The Role of Transcutaneous Nicotine in the Prevention of Postoperative Nausea and Vomiting in Non-smokers
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Prevention of PONV
研究概览
简要总结
The purpose of this study is to determine whether nicotine is effective in the prevention of nausea and vomiting in non-smokers undergoing surgery
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (18-80 years)
- •ASA I-II, non-smokers (or ex-smokers who have not been smoking for more than 2 years)
- •Undergoing elective surgery (ENT, abdominal, urological, gynaecological); and
- •Consenting to take part in the study will be included.
排除标准
- •Smokers (cigarette, pipe, cigar)
- •Patients undergoing nicotine replacement therapy
- •Prolonged postoperative intubation
- •Postoperative nasogastric tube
研究组 & 干预措施
Nicotine patch
Experimental
Nicotinell® Patch 10 cm2, containing 17.5 mg of nicotine, with an average delivery rate of 7 mg of nicotine per 24 hours (= TTS 10)
干预措施: Nicotine (Drug)
Placebo patch
Placebo Comparator
Placebo patch 10 cm2
干预措施: Nicotine (Drug)
结局指标
主要结局
Prevention of PONV
时间窗: 48 hours postoperatively
次要结局
- Adverse effects that may be related to the nicotine patch, for instance, local skin reaction.(48 hours postoperatively)
研究者
研究点 (1)
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