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临床试验/NCT01773044
NCT01773044已完成4 期

Pain on Injection of Propofol: a Comparison of Lidocaine and Alkalinized Lidocaine

Inonu University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2012年9月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

干预措施: alkalinized lidocaine (Drug)

alkalinized lidocaine & lidocaine

Active Comparator

干预措施: Lidocaine (Drug)

alkalinized lidocaine &Placebo

Active Comparator

干预措施: alkalinized lidocaine (Drug)

alkalinized lidocaine &Placebo

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ülkü Özgül

department of anesthesiology

Inonu University

研究点 (1)

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