Ondansetron, orally disintegrating film versus intravenous injection for prevention of post operative nausea vomiting in middle ear and nasal surgeries- A randomized, placebo controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- reduction in incidence of post operative nausea vomiting
研究概览
简要总结
The incidence of post operative nausea and vomiting (PONV) is variable & depends on the patient, as well as type of anaesthesia and surgery. The incidence of PONV after middle ear & nasal surgeries has been reported to be 35-80 %. Ondansetron, a 5HT3 receptor antagonist, has been shown to be an effective prophylactic drug when administered either IV or orally in the form of orally disintegrating tablets.Orally disintegrating film (ODF) formulations are relatively recent innovations in drug administration. This study aims to evaluate the effects of Ondansetron ODF on the incidence of PONV in adult patients undergoing middle ear and functional endoscopic sinus surgeries done under monitored anaesthesia care and to evaluate whether these findings can be extrapolated to its use in day care ear and nasal surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •elective middle ear and nasal surgeries under monitored anaesthesia care.
排除标准
- •raised serum urea and creatinine, advanced liver disease, history of chronic use of sedatives, narcotics or both, history of alcohol or drug abuse, or allergy to any of the study medications.
- •Patients with history of motion sickness or PONV and refusal for inclusion in the study.
结局指标
主要结局
reduction in incidence of post operative nausea vomiting
时间窗: 2, 6, 12, 18, and 24 h postoperatively
次要结局
- incidence of post operative pruritus(2, 6, 12, 18, and 24 h postoperatively)