NCT00734929已完成4 期
A Comparison of the Combination of Aprepitant and Dexamethasone Versus the Combination of Ondansetron and Dexamethasone for the Prevention of Postoperative Nausea and Vomiting (PONV) in Patients Undergoing Craniotomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Cumulative Incidence of Emesis
研究概览
简要总结
We hypothesize that the combination of aprepitant with dexamethasone will provide significantly improved prophylaxis against Postoperative nausea and vomiting compared with the combination of ondansetron and dexamethasone, in patients undergoing craniotomy under general anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A patient is eligible for inclusion in this study if all of the following criteria apply:
- •Age: 18-75 years of age
- •Surgery: craniotomy under general anesthesia.
- •American Society of Anesthesiologists (ASA) Status: ASA: I, II, or III
- •Language: Fluent in the English language
- •Informed Consent: Written informed consent must be obtained.
排除标准
- •A patient will not be eligible for inclusion in this study if any one or more of the following criteria apply within thirty days of patient enrollment in this clinical trial:
- •Medical: Any condition that may impair a patient's ability to complete any of the study assessments or confound interpretation of results.
- •Hypersensitivity: Patient has a known immediate or delayed hypersensitivity reaction or known idiosyncrasy to any of the two study medications, ondansetron, or aprepitant.
- •Other Drugs: Patients should not be taking medications with known antiemetic properties (phenothiazines, butyrophenones, antihistamines), nor should they receive metoclopramide, or other antiemetics preoperatively or 12 hours before the scheduled surgical procedure.
- •Pregnant or lactating females: A pregnancy test will be performed within 24 hours of entering the study for females of childbearing potential.
- •Substance Abuse: Clinically significant abuse of substances (alcohol, illicit or prescribed medications) such that the patient is unable to provide informed consent or reliably complete any of the study assessments.
- •Psychiatric Disease: History of a psychiatric illness that may impair the patient's ability to provide informed consent or complete any of the study assessments.
- •Nausea verbal rating score (VRS): A VRS nausea score > 3 (scale 0-10) in the preoperative holding area before pretreatment with the study medications.
研究组 & 干预措施
1
Experimental
Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia
干预措施: Aprepitant + Dexamethasone (Drug)
2
Active Comparator
Ondansetron 4 mg within 30 min of the end of surgery + Dexamethasone 10 mg after induction of anesthesia
干预措施: Ondansetron + Dexamethasone (Drug)
结局指标
主要结局
Cumulative Incidence of Emesis
时间窗: 48 h
Any vomiting or retching
次要结局
- Incidence of Nausea(Post operative procedure (OP) hours (0-2, 24, 48))
- Incidence of Vomiting (Post OP)(Post OP (0 - 2 hours))
- Incidence of Vomiting (24 Hours)(24 h)
- Use of Rescue Antiemetics (Post OP)(Post OP (0 - 2 hours))
- Use of Rescue Antiemetics (24 Hours)(24 h)
- Use of Rescue Antiemetics (48 Hours)(48 hour)
- Number of Participants With a Complete Response Rate(24 hours Post OP, 48 hours Post OP)
- Average Nausea Score(Post OP hours 0-2, 24 h, 48 h)
- Number of Vomiting Episodes(48 hours)
- Time to First Vomiting(48 h)
- Number of Participants Who Rated Their Satisfaction With Antiemetic Management as "Very Satisfied"(48 hour)
研究者
研究点 (1)
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