COMPARISON OF INTRAVENOUS ONDANSETRON VERSUS COMBINATION OF INTRAVENOUS ONDANSETRON AND ORAL APPREPITANT TO PREVENT POST OPERATIVE NAUSEA VOMITING IN PATIENTS UNDERGOING ELECTIVE CRANIOTOMIES – A PROSPECTIVE RANDOMISED CONTROL TRIAL.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- To assess the efficacy of IV ondansetron when given alone versus combination of IV ondansetron and Oral aprepitant in management of PONV in patients undergoing elective craniotomy surgeries.
研究概览
简要总结
Postoperative nausea and vomiting (PONV) is any nausea, vomiting, or retching in the post-anesthesia care unit during the 48-hour period following surgery.The incidence of PONV following Craniotomy is 22% to 70% without prophylaxis and even with prophylaxis the average incidence was 50%. ASA Guidelines recommend a multi-modal approach for prevention of PONV- combining different classes of antiemetic drugs with diverse mechanisms. Our study aims to compare- IV Ondansetron when used alone and in combination with Oral Apprepitant in patients undergoing elective craniotomy surgeries.
•ONDANSETRON – is a highly potent and selective antagonist at 5-HT3 receptors at two specific sites (i) centrally, in the area postrema/NTS; and (ii) peripherally on vagus nerve terminals.
•APPREPITANT - is a highly selective competitive antagonist of the G-protein–coupled Neurokinin 1 Receptor (NK1) present in the (i) central pattern generator, the nucleus tractus solitarius, and the area postrema to attenuate the likelihood of initiating the complex vomiting reflex. (ii) Peripherally, NK-1Rs exist throughout the gastrointestinal tract. (iii) The binding of the aprepitant to NK-1Rs may attenuate vagal afferent signals, thereby contributing to the antiemetic effect.
PRIMARY OBJECTIVE:
•To assess the efficacy of IV ondansetron when given alone versus combination of IV ondansetron and Oral aprepitant in management of PONV in patients undergoing elective craniotomy surgeries.
SECONDARY OBJECTIVE:
•Assess the incidence of PONV in patients undergoing elective craniotomy surgeries.
•To assess timing and need for rescue anti-emetic and/ or repeat dosing of same drug in treating PONV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Consenting patients undergoing Elective Craniotomy surgeries, under ASA grades 1 and 2.
排除标准
- •Non consenting patients Pregnant patients ASA grading 3 and above Patients with known or suspected to have allergy for study drug Emergency surgery.
结局指标
主要结局
To assess the efficacy of IV ondansetron when given alone versus combination of IV ondansetron and Oral aprepitant in management of PONV in patients undergoing elective craniotomy surgeries.
时间窗: Incidence of PONV will be recorded at initial 0 to 2 hours, at 2 to 6 hours, 6 to 24 and 24 to 48 hours postoperatively.
次要结局
- Assess the incidence of PONV in patients undergoing elective craniotomy surgeries.(To assess timing and need for rescue anti-emetic and/ or repeat dosing of same drug in treating PONV.)