Efficacy of Low Dose Promethazine for Postoperative Nausea and Vomiting
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Absence of emetic episode for 24 h in the postoperative period
研究概览
简要总结
There has been an increase in ambulatory surgical procedures performed across Canada; ambulatory procedures account for almost 70% of all surgeries. Postoperative nausea and vomiting (PONV) and pain are the most frequently reported adverse events by patients prior to discharge after ambulatory surgery. The incidence can be as high as 70 to 80% in high-risk patients.
PONV is a cause of morbidity particularly in gynecological procedures and the incidence of patients experiencing PONV is as high as 58-75%. Apart from delayed recovery, the occurrence of PONV has been linked to gastric aspiration, psychological distress and wound dehiscence. The occurrence of PONV delays patient discharge and further more is a leading cause of unexpected admission after ambulatory anesthesia
Promethazine, is an antiemetic medication that has been widely used over the last 50 years, and although effective at reducing PONV, it tends to cause sedation. In this study, we are trying to determine if a smaller dose of promethazine, in addition to the standard treatment for post-surgical nausea and vomiting, will be more beneficial than the standard treatment on its own.
It is hypothesized that the use of low dose promethazine (3 mg) as part of a multimodal antiemetic regimen will be efficacious in preventing PONV without the sedative effects of promethazine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 60 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient is between 18 - 60 yrs of age
- •2 Patient's health is graded as class I-III according to the American Society of Anesthesiologists physical status classification.
- •The patient has 2 or more of the following risk factors:
- •Non-smoker
- •History of PONV/motion sickness
- •Use of post-operative opioids (current surgery)
- •Undergoing ambulatory gynecological laparoscopic procedures of at least 30 minutes duration
排除标准
- •preexisting nausea, vomiting or retching, gastric outlet or intestinal obstruction
- •clinical evidence of a difficult airway
- •obesity (body mass index > 40 kg m-2)
- •scheduled to receive propofol for anesthesia maintenance
- •current pregnancy
- •psychiatric illness
- •clinically significant major organic disease
- •preoperative QTc interval > 440 ms on electrocardiogram
- •known hypersensitivity to promethazine, granisetron, ondansetron or other 5 HT3-receptor antagonists
研究组 & 干预措施
Promethazine 6.25 mg
干预措施: Promethazine (Drug)
Promethazine 3 mg
干预措施: Promethazine (Drug)
结局指标
主要结局
Absence of emetic episode for 24 h in the postoperative period
次要结局
未报告次要终点
