Olanzapine for the Prevention of Postoperative Nausea and Vomiting After Laparoscopic Surgery in High-risk Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- nausea and/or vomiting score
研究概览
简要总结
Nausea and vomiting (PONV) remain a common problem in surgical units. Even after two or three prophylactic antiemetic interventions, patients with all four of the Apfel risk factors for PONV have an estimated 30 to 40% chance of suffering PONV. Olanzapine as an antiemetic represents a new use of an antipsychotic drug.
详细描述
Aim of the Research, to compare the effects of oral 10 and 5 mg Olanzapine for the Prevention of 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
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA I and II patients
- •undergoing ambulatory laparoscopic gynecologic surgery with general anesthesia
- •patients have at least two of the four Apfel risk factors for PONV2
- •Lack of history of psychiatric and psychotic illnesses.
排除标准
- •ASA III and ≥ IV patients
- •Psychological diseases
- •History of chemotherapy
- •have a pre-existing vestibular disorder or history of dizziness or preexisting nausea or vomiting in the 24 h before surgery, or were being treated with regular antiemetic therapy including systemic corticosteroids.
研究组 & 干预措施
Group 1
patients will receive oral placebo tablets one hour preoperatively
干预措施: Placebo (Drug)
Group 2
patients will receive oral 5 mg Olanzapine tablets one hour preoperatively
干预措施: 5 mg Olanzapine Tablets (Drug)
Group 3
patients will receive oral 10 mg Olanzapine tablets one hour preoperatively
干预措施: 10 mg Olanzapine Tablets (Drug)
结局指标
主要结局
nausea and/or vomiting score
时间窗: first 24 hours postoperative
the occurrence of nausea and/or vomiting by nausea score
次要结局
未报告次要终点
研究者
Amani Hassan Abdel-Wahab
assistant professor
Assiut University