The Effect of Dimenhydrinate on Postoperative Nausea and Vomiting After Abdominal Hysterectomy: Randomized-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 主要终点
- occurrence and times of nausea vomiting
研究概览
简要总结
The aim of this clinical trial is to learn if Dimenhydrinate works to prevent postoperative nausea-vomiting in adult women who undergoing abdominal hysterectomy. The primary question is: Does Dimenhydrinate lower the proportion of postoperative nauseavomiting during the day 1 after surgery. Researcher will compare Dimenhydrinate to a placebo (a-look-alike substance that contains no drug) which will give intravenously when the patient come back to the ward, to see if Dimenhydrinate work to prevent nauseavomiting during the postoperative day1. All participants will receive standard treatment during pre-operative, intra-operative and the immediate post-operative periods. Participants will receive Dimenhydrinate or placebo only one dose after discharge from the recovery room. During the day 1 postoperative, participants will report their symptoms and keep a diary of the number of tmes they use additional anti-emetic drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •18-65 years female
- •undergoing trans abdominal hysterectomy
排除标准
- •undergoing emergency surgery
- •pregnancy or breastfed women
- •post delivery less than 6 weeks
- •history of allergic reaction or precaution to use the protocol drug
- •BMI less than 18 or more than 30 kg/m2
- •Need ICU care after surgery
研究组 & 干预措施
Dimenhydrinate
Dimenhydrinate 50 mg
干预措施: Dimenhydrinate (Drug)
Placebo
NSS 10 ml
干预措施: Dimenhydrinate (Drug)
结局指标
主要结局
occurrence and times of nausea vomiting
时间窗: at ward, 6, 12, 24 hr postoperation
次要结局
未报告次要终点
研究者
Preeyaporn Jirakittidul
Assist Prof Dr. Preeyaporn Jirakittidul
Mahidol University
