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临床试验/NCT01345981
NCT01345981已完成不适用

A Comparison of Pain Severity on Injection of MCT/LCT Propofol Between Lidocaine 20 mg, 40 mg, and Without Lidocaine.

Prince of Songkla University1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2008年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
210
试验地点
1
主要终点
pain on injection

研究概览

简要总结

To compare the severity of pain on injection of MCT/LCT propofol with lidocaine 20 mg, 40 mg, and without lidocaine.

详细描述

Background: Intravenous injection of propofol produces pain. Many factors are involved and various techniques have been tried to minimize the propofol-induce pain with variable results.

Objective

To compare the severity of pain on injection of MCT/LCT propofol with lidocaine 20 mg, 40 mg, and without lidocaine.

Design: Randomize controlled trial. Method: Two hundred and ten ASA class I - III patients undergoing elective surgery were blinded and equally allocated into 3 groups. Patients in group N, L1, and L2 received MCT/LCT propofol 10 ml mixed with 0.9% NaCl 2 ml, 1% lidocaine 2 ml, and 2% lidocaine 2 ml respectively. Pain at time of propofol injection was assessed by blinded anesthesiologist on a four point scale ; 0 = no pain, 1 = mild pain, 2 = moderate pain, and 3 = severe pain. Results: Patient's demographic data of each group were similar. There were significant differences in the incidence of propofol injection without pain among groups (p<0.001). The numbers of patients who had moderate and severe pain in groups L1 and L2 were significantly less than those in group N (p<0.001). The mean blood pressure and heart rate were not significant differences in among groups. Conclusion : The amount of 20 mg, and 40 mg lidocaine to MCT/LCT propofol in our study is equally effective in decreasing pain and more effective than MCT/LCT propofol alone group significantly. They were no significant differences in hemodynamics change in among groups.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA class I - III patients
  • undergoing elective surgery
  • age 18-75 years

排除标准

  • allergy to propofol and lidocaine
  • abnormal liver and renal functions
  • has psychological problem or drug abuse
  • has recieved analgesic drug 2 weeks prior to surgery
  • risk of aspiration

研究组 & 干预措施

lidocaine 20 mg

Experimental

intravenous lidocaine

干预措施: Lidocaine (Drug)

lidocaine 40 mg

Experimental

intravenous lidocaine 40 mg

干预措施: Lidocaine (Drug)

normal saline

Placebo Comparator

2 ml

干预措施: Lidocaine (Drug)

结局指标

主要结局

pain on injection

时间窗: 30 minutes

4 points score for pain:o=no pain,1=mild pain,2=moderate pain,3=severe pain after propofol injection

次要结局

  • hemodynamic change(30 minutes)

研究者

申办方类型
Other

研究点 (1)

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