Effect of Ondansetron on Patient Tolerance, Efficacy and Endoscopist Workload in Unsedated Endoscopy for Upper Gastrointestinal Bleeding
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- patient cooperation
研究概览
简要总结
The goal of this clinical trial is to evaluate whether intravenous ondansetron can improve patient tolerance and reduce discomfort during unsedated emergency esophagogastroduodenoscopy (EGD). The main questions it aims to answer are:
- Does pre-procedural administration of ondansetron improve patient cooperation during emergency EGD?
- Does it improve endoscopic field visibility and improve the success rate of initial endoscopic hemostasis？
- Does it reduce the operator's perceived workload or stress?
Researchers will compare patients who received intravenous ondansetron with patients who received placebo to see if ondansetron can reduce patient discomfort and improve patient cooperation, therefore improve the quality of the procedure.
Participants will receive either intravenous ondansetron and dyclonine hydrochloride mucilage or intravenous saline and dyclonine hydrochloride mucilage prior to the endoscopic procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of suspected or confirmed upper gastrointestinal bleeding with an indication for emergent endoscopic intervention.
- •Capability to provide informed consent.
排除标准
- •Presence of any contraindication to upper gastrointestinal endoscopy.
- •Concurrent severe primary diseases of the respiratory, cardio-cerebrovascular, renal, central nervous, or hematologic systems.
- •Pregnancy.
- •Presence of neuropsychiatric disorders, including severe depression or severe anxiety.
- •Presence of a known history of cardiac arrhythmia.
- •Allergic to dyclonine hydrochloride or ondansetron.
研究组 & 干预措施
control
干预措施: Placebo (Drug)
intravenous ondansetron
干预措施: intravenous ondansetron (Drug)
结局指标
主要结局
patient cooperation
时间窗: from the beginning to the end of the endoscopic procedure
evaluated by the endoscopist in numeric rating scale, 0 stands for not good at all, 10 stands for completely satisfied.
次要结局
- Recurrence of UGIB in 30 days(From the day of the procedure to 30 days after it)
- adverse event(from the beginning of the intervention to the end of the endoscopic procedure)
- Procedure duration(From the start to the end of the endoscopic procedure)
- endoscopist workload(From the beginning to the end of the endoscopic procedure)
- gagging intensity of patient(from the beginning to the end of the endoscopic procedure)
- visualization quality(During the endoscopic procedure.)
- Success rate of initial endoscopic hemostasis(from the beginning to the end of the endoscopic procedure)
- adverse event(from the beginning of the intervention to 1 week after the endoscopic procedure.)
- Proportion of patients needing repeat endoscopy within 72 hours(from the time of the endoscopic procedure to 3 days after the endoscopic procedure.)
- Recurrence of UGIB in 7 days(from the day of the procedure to 7 days after it)
研究者
DONG WU
Chief physician of Gastroenterology
Peking Union Medical College Hospital