Comparison Between Ondansetron 8 mg and Lidocain 40 mg in Preventing Pain Due to Propofol Injection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- The Degree of pain due to Propofol Injection
研究概览
简要总结
This study aims to compare the effectivity between ondansetron 8 mg and lidocain 40 mg in preventing pain due to propofol injection
详细描述
Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study. Non-invasive blood pressure (NIBP) monitor, ECG and pulse-oximeter was set on the subjects in the operation room. After a tourniquet made from NIBP cuff were inflated, subjects were given either Ondansetron 8 mg or Lidocain 20 mg intravenously, then the tourniquet was set off. Hemodynamic data was recorded. Propofol 1 mg/kg of body weight (BW) injection was given. Verbal rating scale was used to measure pain at 0 s, 5 s and 30 s. Data was analyzed using Statistical Package for the Social Sciences (SPSS), for numeric data using uni-variate analysis and bi-variate analysis. Significant value is p<0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 18-65 years old
- •Subjects were planned to undergo general anesthesia with propofol
- •Subjects with Body Mass Index (BMI) 18-35 kg/m2
- •Subjects with American Society of Anesthesiologists (ASA) physical status of I-II
- •Subjects with signed informed consent.
排除标准
- •Subjects with allergies to propofol, lidocain, ondansetron
- •Subjects with massive cardiac disorder
- •Subjects with cardiac rhythm disorder with or without treatment
- •Subjects with unstable hemodynamic
- •Subjects with contraindication to propofol, lidocain, ondansetron
- •Subjects with intubation and ventilation difficulty
- •Subjects with decreased consciousness, seizure history or head injury
- •Subjects with analgesic treatment history
- •Subjects with pregnancy.
- •Drop out criteria:
- •Subjects with allergic reactions induced by propofol, lidocain, ondansetron
- •Uncooperative subjects
- •Subjects in emergency
- •Subjects with difficult vein access in the dorsum manus
- •Subjects with infection and/or inflammation in the planned intravenous cannulation location.
研究组 & 干预措施
Ondansetron
Ondansetron 8mg (2mg/cc) was given intravenously via a 20 G vein canula
干预措施: Ondansetron 8 mg (Drug)
Lidocain
Lidocain 40mg (20mg/cc + 2cc of normal saline) was given intravenously via a 20 G vein canula
干预措施: Lidocain 40 mg (Drug)
结局指标
主要结局
The Degree of pain due to Propofol Injection
时间窗: Day 1
The degree of pain due to propofol injection was measured at 0 second, 15 seconds, 30 second, using verbal rating scale
次要结局
未报告次要终点
研究者
Aries Perdana
Consultant, Anesthesiologist
Indonesia University