Transdermal Nicotine in Female Patients at High Risk for PONV
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The primary outcome measure is whether the patient experienced post-operative nausea and/or vomiting.
研究概览
简要总结
The purpose of this study is to see if the nicotine patch reduces post operative nausea and/or vomiting (PONV) among non-smoking patients who are at high risk of PONV.
详细描述
There are certain known risk factors for post-operative nausea and/or vomiting: the use of opioids during surgery, female gender, laparoscopic surgery, gynecologic surgery, strabismus repair, the use of a general anesthetic, obesity, and non-smoker. Patients with four or more of these risk factors have an 80% occurrence rate of post-operative nausea and/or vomiting and are classified as "high risk". It has been shown that those who use tobacco have about a 50% reduction in post-operative nausea and/or vomiting.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age 18-65
- •health patient or acute illness
- •undergoing outpatient-type general surgery, especially those associated with increased incidence of post-operative nausea and/or vomiting such as gynecological procedures
- •undergoing general anesthesia for the surgery
- •receiving opioids during surgery
- •non-smokers
排除标准
- •history of any heart condition
- •history of uncontrolled hypertension, or presence of any condition that could be made drastically worse by an increase in blood pressure
- •history of an aneurysm
- •active tobacco use within the past five years
- •works or lives in the presence of cigarette smoke
- •mentally ill
- •prisoners
- •history of allergic reaction to nicotine or to adhesive patches
- •history of allergic reaction to propofol, versed, fentanyl, zofran, decadron, and reglan
研究组 & 干预措施
1
The nicotine patch will be applied prior to surgery and remain on the right upper back for 24 hours.
干预措施: transdermal nicotine patch (Drug)
2
The placebo patch has no active ingredients and the same inactive ingredients as the nicotine patch. It will be administered the same fashion as the nicotine patch.
干预措施: placebo patch (Drug)
结局指标
主要结局
The primary outcome measure is whether the patient experienced post-operative nausea and/or vomiting.
时间窗: The outcome measure will be assessed within 24 hours after the application of the patch.
次要结局
- The secondary outcome is to assess how many episodes of post-operative nausea and/or vomiting the patient experiences.(The outcome measure will be assessed within 24 hours of the application of the patch.)
研究者
Stuart Hart
Director of Obstetric Anesthesiology
Ochsner Health System