Comparison of efficacy of palonosetron & dexamethasone and ondansetron & dexamethasone combination for prevention of postoperative nausea and vomiting in patients undergoing middle ear surgery- A randomized double blind study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence and severity of nausea and vomiting
研究概览
简要总结
Postoperative nausea and vomiting (PONV) is a common and distressing complication after middle ear surgeries. An incidence of up to 80% has been reported in literature undergoing middle ear surgery under general anesthesia. Various drugs have been used to prevent PONV. The 5-HT3 receptor antagonists are now a first line option because of effectiveness, more safety and favourable side effects profile. Ondansetron was the first 5-HT3 receptor antagonist. Palonosetron is the most recently introduced member of this class. It has unique chemical structure, the interaction pattern with the 5HT3 receptor is dfferent from earlier 5-HT3 receptor antagonists. Intravenous dexamethasone reduces the incidence of PONV by a central mechanism. Hence this study is designed to evaluate and compare the efficacy of palonosetron & dexamethasone and ondansetron & dexamethasone combination for prevention of PONV in middle ear surgery.
All selected patients will be randomized in to 2 groups (30 in each group) depending on the drug given.
Group O - Ondansetron (8mg) & Dexamethasone (8mg) I.V. prior to induction of anesthesia
Group P - Palonosteron (0.075mg) & Dexamethasone (8mg) I.V. prior to induction of anesthesia
Primary outcome - Incidence and severity of nausea and vomiting
Secondary outcome - Patient satisfaction score and requirement of rescue antiemetic
Statistical analysis will be done after completion of study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA grade I and II
- •Non hypertensive and non diabetic.
排除标准
- •1.Known allergy to study drug 2.Use of antiemetic drugs 24 hours before surgery.
- •3.Morbid obesity (body mass index>40) 4.Chronic use of opioids 5.Diabetes and hypertension 6.Hepatic, renal or cardiovascular dysfunction 7.Psychiatric patients 8.Pregnant and lactating women.
结局指标
主要结局
Incidence and severity of nausea and vomiting
时间窗: During postoperative period 0–2 hr, 2–6 hr and 6–24 h after surgery
次要结局
- Patients satisfaction score(Requirement of rescue antiemetic)