Comparison of Ramosetron With Ondansetron for Prevention of Intrathecal Morphine Induced Nausea and Vomiting After Primary Total Knee Arthroplasty: A Randomized Control Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 99
- 主要终点
- Incidence rate of postoperative nausea and vomiting
研究概览
简要总结
We would like to know the prophylactic anti-emetic effect of ramosetron compare to ondansetron in patient undergone total knee arthroplasty with spinal anesthesia and intrathecal morphine .
详细描述
The patients were allocated into 2 groups by computerized block randomization according to a computer generated randomization. Treatment allocations were contained in sealed envelopes that were opened after patient enrollment. Patients received either 8 mg of intravenous (IV) ondansetron or 0.3 mg of IV ramosetron 10 minutes before spinal anesthesia and intrathecal morphine. All of the unilateral TKAs were done by one orthopedic surgeon using the same minimally invasive surgical technique and the same prosthesis.
Patients were monitored for incidence of Post Operative Nausea Vomiting(PONV) every 6 hours until 24 hours, and 24-48 hours postoperatively. Common adverse drug reactions associated with serotonin receptor antagonists (pruritus, dizziness, and headache) were also recorded.
The sample size calculation was based on the ability to detect a difference in incidence of postoperative nausea in between the two groups of 40% i.e. 50% in the ondansetron arm, and 30% in the ramosetron arm, consistent with a previous study. Using a power of 80% (β=0.2) and a two sided significance level(alpha) of 0.05, 45 patients in each group were required.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 50-80 years with a diagnosis of primary OA undergoing unilateral TKA
- •American Society of Anesthesiologist (ASA) physical status I-III
- •Giving written informed consent
排除标准
- •Body mass index (BMI) > 35 kg/m2
- •Unable to undergo spinal anesthesia
- •History of allergic to study drugs
- •Impaired renal and/or hepatic function
- •Use of systemic steroids and anti-emetics within 24 hours of operation
研究组 & 干预措施
ramosetron group
Patients received 0.3 mg of intravenous ramosetron before spinal anesthesia and intrathecal morphine
干预措施: ramosetron (Drug)
ondansetron group
Patients received 8 mg of intravenous ondansetron before spinal anesthesia and intrathecal morphine
干预措施: Ondansetron (Drug)
结局指标
主要结局
Incidence rate of postoperative nausea and vomiting
时间窗: 48 hours after the operation
次要结局
- number of patients require for anti-emetic medicine(48 hours after the operation)
- visual analog scale for pain(48 hours after operation)
研究者
piya pinsornsak
associate professor
Thammasat University