To evaluate the effectiveness of Apfel score based prophylaxis versus Universal prophylaxis to reduce the need of antiemetic for post-operative nausea and vomiting in patients under general anaesthesia at SMS Medical College Jaipur
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- 1.To assess and compare the number of patient having post operative nausea and vomiting (PONV) between the two groups.
研究概览
简要总结
Post-operative nausea and vomiting (PONV) is a common and distressing complication that significantly impacts patient well-being, particularly within the first 24 hours following surgery**.**
The primary goal of prophylactic measures against PONV is to reduce its occurrence, thereby enhancing the overall quality of patient care and facilitating smoother recovery processes. To address this issue, various predictive scoring systems have been developed to identify patients at higher risk of developing PONV, enabling more targeted prophylactic intervention.
Among the most notable of these systems are those introduced by Apfel et al.in Germany and Koivuranta et al in Finland. These systems utilize specific risk factors to stratify patients according to their likelihood of experiencing PONV, thereby allowing clinicians to tailor prophylactic treatments to those most likely to benefit.
The Apfel scoring system, in particular, has gained widespread acceptance and is frequently used in clinical settings. This system evaluates patients based on factors such as gender, history of motion sickness or PONV, non-smoking status, and the use of postoperative opioids, assigning a score that correlates with the patient’s risk level.
With this background, we plan to conduct this study to evaluate the effectiveness of Apfel score based prophylaxis versus universal prophylaxis to reduce the need of antiemetic for post operative nausea and vomiting in patients under general anaesthesia .
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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
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patient schedule for various elective surgery under general anaesthesia required endotracheal intubation.
- •2 Patient willing to give written informed consent.
- •3.Body mass index less than 30kg/m
- •4.American society of anaesthesiologist (ASA) class 1 and 2.
排除标准
- •1.Patient required post operative mechanical ventilation .
- •2.Patient with known allergy to ondansetron.
- •3.Patient in whom metoclopramide has been used for aspiration prophylaxis.
结局指标
主要结局
1.To assess and compare the number of patient having post operative nausea and vomiting (PONV) between the two groups.
时间窗: 1.Episodes of Nausea and vomiting at the end of 24 hours after the surgery. | 2. Number of doses of anti emetic given at the end of 24 hours after the surgery.
2.To assess and compare the dose of rescue antiemetic (inj.metaclopramide10mgiv,inj dexamethasone0.2mg/kg iv) required in first 24 Hours post operatively between the two groups
时间窗: 1.Episodes of Nausea and vomiting at the end of 24 hours after the surgery. | 2. Number of doses of anti emetic given at the end of 24 hours after the surgery.
次要结局
- To assess and compare the difference in proportion of patient having side effects (palpitations, constipation, headache etc.)if between two groups(At the end of 24 hours after the surgery .)
研究者
Dr Samridhi Nanda
Sawai Man Singh Medical College and Attached hospital