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临床试验/NCT06395064
NCT06395064尚未招募不适用

The Effect of Dimenhydrinate on Postoperative Nausea and Vomiting After Abdominal Hysterectomy: Randomized-controlled Trial

Preeyaporn Jirakittidul0 个研究点目标入组 160 人开始时间: 2024年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
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

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

Active Comparator

Dimenhydrinate 50 mg

干预措施: Dimenhydrinate (Drug)

Placebo

Placebo Comparator

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

发起方
Preeyaporn Jirakittidul
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Preeyaporn Jirakittidul

Assist Prof Dr. Preeyaporn Jirakittidul

Mahidol University

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