Comparision of efficacy of ondansetron versus palanosetron versus ramosetron for prevention of post operative nausea and vomiting (PONV) in elective craniotomy surgeries- A randomized double blinded prospective study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- To evaluate and compare for the incidence of complete response ( no nausea, no vomiting, no use of rescue medication)
研究概览
简要总结
PONV referred to as the big little problem or the little big problem after surgery or anaesthesia is one of the most common perioperative concerns with a relatively high incidence of up to 73 percent after craniotomy The incidence of PONV reaches 25 to 30 percent
often rising to 80 percent after general anaesthesia among patients without prophylactic intervention PONV in neurosurgical patients causes pain tachycardia aspiration patient discomfort intravascular volume depletion dehydration acid base disturbances and elecrolyte imbalances like symptomatic hyponatremia hypokalemia hypochloremia it may also lead to increase in intracranial pressure and wound dehiscence hematoma which may be deleterious to the patients therefore it is imperative that PONV be managed optimally for after elective craniotomy because effective treatments to prevent or manage post operative nausea and vomiting allow early mobilization early food intake and improve overall patient satisfaction it is of even more importance in neurosurgical patients as even mild to moderate PONV may raise confusion regarding features of raised intracranial pressure in the postoperative period
severe pharmacological interventions including anticholinergics antihistamines corticosteroids dopamine receptor antagonists and serotonin receptor antagonists for treating and preventing PONV have been assesed
the lack of sedative effects makes 5HT3 antagonists the gold standard drugs for PONV prophylaxis in craniotomies when postoperative clinical neurological assesments are required
To the best of our knowledge there are no studies that have evaluated and compared the antiemetic efficacy of ondansetron palonosetron and ramosetron after elective craniotomy
Therefore we have undertaken this study and hypothesized that palonosetron and ramosetron would provide a greater clinical benifit than ondansetron in this surgical cohort
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 19.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA PHYSICAL STATUS 1, 2 UNDERGOING ELECTIVE CRANIOTOMY SURGERIES.
排除标准
- •Patients aged less than 19 and more than 65, belonging to ASA class 3 or more, patients having gastric diseases,history of vomiting, history of craniotomy,on antibiotics cancer chemotherapy, anti emetic use within 24hours, severe renal or hepatic insufficiency,borderline QT prolongation, chronic use of opioids ,on antidepressant medication, undergoing emergency surgeries with poor GCS , who could not communicate,pregnant.
结局指标
主要结局
To evaluate and compare for the incidence of complete response ( no nausea, no vomiting, no use of rescue medication)
时间窗: In first 48 hours between three groups
次要结局
- To evaluate & compare for the incidence of vomiting, retching, nausea ( intensity/ severity)(0 TO 2, 2 TO 12, 12 TO 24 AND 24 TO 48 HOURS POSTOPERATIVELY)
- To compare side effects profile between three groups(0 TO 2, 2 TO 12, 12 TO 24 AND 24 TO 48 HOURS POSTOPERATIVELY)
- To look for the need for rescue anti emetic(0 TO 2, 2 TO 12, 12 TO 24 AND 24 TO 48 HOURS)
- To evaluate patient satisfaction using Likert scale between three groups(48 HOURS POSTOPERATIVELY)
研究者
DR ASHWITHA VAIDYA
NIZAMS INSTITUTE OF MEDICAL SCIENCES