Comparison of Hyperbaric Prilocaine 2% 50 Mg and Hyperbaric Bupivacaine 0.5% 12.5 Mg Against Spinal Anesthesia Recovery Time in Cystoscopy Procedure
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Visual analog scale (VAS)
研究概览
简要总结
Data regarding the comparison of recovery time from spinal anesthesia between prilocaine and bupivacaine are still relatively limited. The aim of this study was to compare the speed of recovery of spinal anesthesia with hyperbaric prilocaine 2% 50 mg compared to hyperbaric bupivacaine 0.5% 12.5 mg in cystoscopy procedures. By knowing the speed of recovery time, it is hoped that the patient will recover faster, be transferred to the treatment room faster, be safer, and the length of treatment will be shorter so that the quality of service for cystoscopy procedures and patient satisfaction is getting better.
详细描述
This study is a double-blind randomized clinical trial. This study compared the speed of recovery from spinal anesthesia, as many as 66 subjects were divided into two groups, namely hyperbaric prilocaine 2% 50 mg and hyperbaric bupivacaine 0.5% 12.5 mg who would undergo a cystoscopy procedure. This research was conducted in the urological surgery room of RSCM in January - October 2022, after passing the ethical review and obtaining a location permit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female over the age of 18,
- •ASA physical status I - III,
- •Normal body mass index according to Quetelet's index,
- •Willing to be a research participant and comply with the research rules.
排除标准
- •Have a history of allergy to prilocaine or bupivacaine,
- •Have a previous history of walking disorders
- •Spinal anesthesia is contraindicated.
研究组 & 干预措施
Prilocaine
50 mg hyperbaric 2% prilocaine (2.5 ml volume) + 25 mcg fentanyl (0.5 ml volume)
干预措施: Prilocaine (Drug)
bupivacaine
12.5, 5 mg hyperbaric 0.5% bupivacaine (2.5 ml volume) + 25 mcg fentanyl (0.5 ml volume)
干预措施: Prilocaine (Drug)
结局指标
主要结局
Visual analog scale (VAS)
时间窗: 24 hour
Pain measurement scale felt by patients with a score of 0 = no pain and a score of 10 = unbearable severe pain.
次要结局
- Complication(24 hour)
研究者
Aida Rosita Tantri
PhD
Indonesia University