Pain on Injection of Propofol: a Comparison of Lidocaine and Alkalinized Lidocaine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Pain on injection of propofol
研究概览
简要总结
Aim: The aim of this study was to compare the efficacy of pretreatment 0.5 mg/kg lidocaine and 0.5 mg/kg alkalinized lidocaine for prevention of propofol induced pain.
Methods: In this double-blind, placebo controlled study, 300 adults patients ASA I or II, scheduled to undergo elective surgery, were randomly assigned into three groups of 100 each. Group L, recevied 0.05 mL/kg lidocaine (% 2 lidocaine 5 mL + 5 mL SF), Group A, 0.05 mL/kg lidocaine with bicarbonate ( % 2 lidocaine 5 mL + 1 mL %8,4 NaHCO3+ 4 mL SF) and control group received isotonic saline pretreatment in the dorsum of the hand, followed by propofol 30 sec later. A blinded researcher assessed the patient's pain level via a four-point scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- 是
入选标准
- •undergoing elective surgery
排除标准
- •allergy to the study drug
研究组 & 干预措施
alkalinized lidocaine & lidocaine
干预措施: alkalinized lidocaine (Drug)
alkalinized lidocaine & lidocaine
干预措施: Lidocaine (Drug)
alkalinized lidocaine &Placebo
干预措施: alkalinized lidocaine (Drug)
alkalinized lidocaine &Placebo
干预措施: Placebo (for alcalinized lidocaine) (Drug)
结局指标
主要结局
Pain on injection of propofol
时间窗: 5 th minutes after propofol injection
次要结局
未报告次要终点
研究者
Ülkü Özgül
department of anesthesiology
Inonu University
