The Effect of Additional Administration of Ramosetron on Late PONV (Postoperative Nausea and Vomiting) in Patients Undergoing Breast Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- number of PONV
研究概览
简要总结
The purpose of this study was to evaluate the effectiveness of additional ramosetron injection for controlling late postoperative nausea and vomiting (PONV) after breast surgery in high risk PONV patients. The investigators compared PONV amomng 3 groups- group C: no additional ramosteron, group B: two additional ramosteron doses at 12 hour interval, group M: two additional ramosetron doses mix to the intraveonus patient controlled analgesia.
详细描述
The investigators included high risk patients of PONV with a score of 3 or more as measured by the Apfel's score and over 18 years old who receive breast surgery and intravenous patient controlled analgesia. All patients was received ramosetron 0.3 mg at the end of surgery. The patients were evaluated for number of PONV (nausea, vomiting, retching) at 1, 6, 24, and 48 hours postoperatively. Nausea was defined as an unpleasant feeling of vomiting. Retching was defined as an excessive contraction or a regular movement. of the respiratory muscles where no gastric contents were excreted, and vomiting was defined as the excretion of gastric contents. PONV were further detailed quantified using the RINVR score (Rhodes Index of Nausea, Vomiting, and Retching) which enabled the patients' objective and subjective symptoms to be evaluated as a simple and reliable methods.
Intravenous injection of ondansetron 4 mg was administered as a rescue antiemetic. The patients were evaluated 2 hours after ondansetron administration. If the symptom persisted, use of second rescue antiemetics dexamethasone 5 mg.
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
- Double (Participant, 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
- 是
入选标准
- •age over 18 years
- •American Society of Anesthesiologists (ASA) physical status I or II
- •requesting IV PCA (patient control of analgesia) for pain control
- •the high-risk group of PONV with a score of 3 or more as measured by the Apfel's score.
排除标准
- •emergency operation
- •re-operation
- •drug abuse, allergy
- •major organ disease (gastrointestinal, cardiovascular, respiratory, cerebral, renal or hepatic disease)
- •pregnancy
- •lactation
- •previously use of antiemetics or systemic steroids within 48 before surgery
研究组 & 干预措施
group B
receive ramosetron i.v. 0.3mg at the end of surgery with two additional doses of ramosetron at 12- and 24- hour postoperative time points
干预措施: Ramosetron Hydrochloride (Drug)
group M
receive ramosetron i.v. 0.3mg at the end of surgery followed ramosetron 0.6 mg mix with the patient-controlled analgesia (PCA) regimen
干预措施: Ramosetron Hydrochloride (Drug)
结局指标
主要结局
number of PONV
时间窗: 24hour postoperatively
number of nausea, vomiting, retching
次要结局
- number of PONV(1hour, 6hour, 48 hour postoperatively)
- Rhodes Index of Nausea, Vomiting, and Retching (RINVR) score(1hour, 6hour, 24hour, 48 hour postoperatively)
研究者
Eunsoo Kim
Associate professor
Pusan National University Hospital