Pre-operative Olanzapine as Prophylactic Antiemetic in Oncologic Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- incidence of postoperative nausea and vomiting
研究概览
简要总结
Olanzapine has been used as prophylactic antiemetic for chemotherapy induced nausea and vomiting.
The project aims to evaluate the efficacy of olanzapine in combination with ondansetron and dexamethasone in patients at high risk of postoperative nausea and vomiting, with previous history of nausea and vomiting induced by prior chemotherapy, submitted to medium and large surgery.
详细描述
Double blinded randomized clinical trial. Fifty patients will be selected for each group. Group A will receive 10mg olanzapine in the preoperative and group B will receive placebo in the preoperative period. Both groups will receive intravenous general anesthesia combined with epidural. All patients will receive epidural PCA.
The primary outcome of this study is the incidence of post-operative nausea and vomiting. The power of analysis was based on the following parameters: type error I (α = 0.05), error II (β = 0.8), 95% confidence interval and hypothesis test two-tailed. Thus, 42 patients are indicated per group to obtain reduction of the incidence of nausea and / or vomiting of the population risk from 60% to 30%. The population will be composed of 100 patients because it is assumed that percentage of loss of 10% per group.
The statistical analysis will be performed in program R version 3.5.1. The results obtained will be presented as mean + standard deviation for continuous data or absolute frequency for described data.
For quantitative variables, the Student's t-test will be used for with normal distribution or Mann-Whitney for non-distributed data normal.
For qualitative variables, the chi-square test will be used or Fisher's exact test. Significant difference is defined as p, 0.05.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
olanzapine tablets
PATIENT WILL TAKE OLANZAPINE 10 MG, 1 hour BEFORE SURGERY
干预措施: Olanzapine (Drug)
Starch tablets
PATIENT WILL TAKE PLACEBO 1 hour BEFORE SURGERY
干预措施: Olanzapine (Drug)
结局指标
主要结局
incidence of postoperative nausea and vomiting
时间窗: 0-24 hours
nausea and vomiting/ retching (dichotomous variable)
次要结局
- incidence of side effects(24-48 hours)
- incidence of postoperative nausea and vomiting(24-48 hours)
- incidence of postoperative vomiting/retching(24-48 hours)
- incidence of postoperative nausea(24-48 hours)
- incidence of severe PONV(24-48 hours)
- incidence of nausea severity(24-48 hours)