NCT06475846已完成2 期
A Evaluate HRS5580 for Injection for Prevention of Postoperative Nausea and Vomiting Efficacy and Safety of Ⅱ Period, Randomized, Multicenter, Dose of Exploration, Positive Control, Placebo-controlled, Double-blind, Double Simulation Trials
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 235
- 试验地点
- 2
- 主要终点
- No vomiting rate within 72 hours after extubation
研究概览
简要总结
The study is being conducted to evaluate the efficacy, and safety of HRS5580 for preventing of postoperative nausea and vomiting in adults. To explore the reasonable dosage of HRS5580 for postoperative nausea and vomiting.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide a written informed consent
- •Plan to undergo elective surgery under general anesthesia；
- •≥18 years old
- •Meet the weight standard
- •Conform to the ASA Physical Status Classification
- •Expected postoperative hospital stay ≥72 hours
- •PONV risk factors ≥3
排除标准
- •Subjects with vomiting and/or retching and nausea occurred before surgery
- •Subjects with a history of vestibular disease, central nervous system and other system diseases
- •Subjects with a previous history of chronic nausea or vomiting/retching
- •Subjects with a history of myocardial infarction or unstable angina pectoris
- •Subjects with atrioventricular block or cardiac insufficiency
- •Subjects with a history of ischemic stroke or transient ischemic attack
- •Subjects with poor blood pressure control after medication
- •Abnormal electrocardiogram
- •Abnormal values in the laboratory
- •Allergic to a drug ingredient or component
- •Received treatment with potential antiemetic effects before starting the investigational product
- •Subjects who received chemotherapy prior to surgery
- •Use of drugs that affect the antiemetic effect, and the time between the last use of the test drug and the start of the time is less than 5 half-lives
- •Plan to receive local anesthesia only or total intravenous anesthesia only
- •Subjects who are expected to require an in-situ nasogastric tube or orogastric tube after completion of surgery
- •Subjects expected to be transferred to the ICU at the end of surgery
- •Pregnant or nursing women
- •No birth control during the specified period of time
- •Participated in clinical trials of other drugs (received experimental drugs)
- •The inestigators determined that other conditions were inappropriate for participation in this clinical trial
研究组 & 干预措施
Treatment group B: HRS5580
Experimental
干预措施: HRS5580 (Drug)
Treatment group A: HRS5580
Experimental
干预措施: HRS5580 (Drug)
Treatment group C: HRS5580
Experimental
干预措施: HRS5580 (Drug)
Treatment group D: Ondansetron
Active Comparator
干预措施: Ondansetron (Drug)
Treatment group E: blank preparation.
Placebo Comparator
干预措施: blank preparation (Drug)
结局指标
主要结局
No vomiting rate within 72 hours after extubation
时间窗: at 72 hours after extubation
次要结局
- Complete response rate (defined as the proportion of subjects without vomiting and receiving no rescue therapy) at 24, 48, 72, 96, and 120 hours after extubation(at24, 48, 72, 96, and 120 hours after extubation)
- Proportion of participants not receiving rescue medication within 24, 48, 72, 96, and 120 hours of extubation(at 24, 48, 72, 96, and 120 hours of extubation)
- No vomiting at 24, 48, 96, and 120 hours after extubation,(at 24, 48, 96, and 120 hours after extubation)
- Proportion of subjects who did not experience significant nausea within 24, 48, 72, 96, and 120 hours after extubation(at 24, 48, 72, 96, and 120 hours after extubation)
研究者
研究点 (2)
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