Efficacy of Ondansetron with and without venous occlusion in the reduction of Propofol injection pain, A Double Blind Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Incidence of propofol injection pain in the three study groups.
研究概览
简要总结
This double-blind randomized controlled trial aims to evaluate the efficacy of ondansetron pretreatment with and without venous occlusion in preventing propofol injection pain. A total of 174 adult patients undergoing elective surgery at AIIMS Gorakhpur will be enrolled. After standard monitoring and pre-oxygenation, patients will receive the allocated intervention, followed by a standardized propofol infusion. Pain at the injection site will be assessed using the Verbal Numerical Rating Scale. The primary outcome is the incidence of propofol injection pain, while secondary outcomes include pain severity, postoperative nausea and vomiting, and any adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator 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
- •Patients aged
- •60 years old, of either sex, physical status (ASA) I and II, who are scheduled for elective surgery under general anaesthesia with propofol induction with 20-gauge IV cannula at the dorsum of hand prior to surgery.
排除标准
- •Patient refusal, Patients allergic to ondansetron, lignocaine or propofol,Patients who did not receive propofol for induction,Patients who used apomorphine, dronedarone, monoamine oxidase inhibitors and serotonergic drugs, Patients with cardiac arrhythmia like prolonged QT Syndrome or 2nd/3rd degree AV Block, Patients who had chronic pain , Patients who did not have 20G IV Cannula on the dorsum of the hand, Patients who received rapid sequence intubation technique.
结局指标
主要结局
Incidence of propofol injection pain in the three study groups.
时间窗: At the time of giving injection
次要结局
- Severity of propofol injection pain in the three study groups.(till post operative 2 hours)
- Incidence of postoperative nausea & vomiting in the three study groups,(till post operative 2 hours)
- Incidence of adverse effects, if any.(till post operative 2 hours)
研究者
Priyanka Dwivedi
AIIMS Gorakhpur