Median Effective Dose of Lidocaine for the Prevention of Pain Caused by the Injection of Propofol Formulated With Medium-/Long-chain Triglycerides
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- The appearance of intravenous injection pain
研究概览
简要总结
Propofol is widely used in general anesthesia induction, but the occurrence of peripheral intravenous pain is relatively high, causing anxiety, fear and other adverse emotions in patients , aggravating the stress response, and even leading to adverse events of cardiovascular system . The use of mediate-long chain fat emulsion propofol partly reduces the incidence of injection pain but patients can still suffer from different degrees of pain. Advanced intravenous injection of lidocaine can alleviate the pain of propofol injection, but its application method and dose are controversial. It is worthy of further discussion on how to select the appropriate dose of advanced intravenous injection of lidocaine to effectively prevent the injection pain of mediate-long chain fat emulsion propofol, and simultaneously avoid the adverse reactions of intravenous lidocaine, thus improving patient satisfaction and perioperative safety. In this study, in order to provide clinical references, sequential method was used to find the median effective dose (ED50) by means of pre-intravenous injection of lidocaine to suppress pain in mediate-long chain fat emulsion propofol injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Ages ranged from 18 to
- •ASA Ⅰ or Ⅱ level.
排除标准
- •Allergy or contraindication to lidocaine or propofol; required for Central venipuncture catheterization;
- •Abnormal liver or kidney function;
- •Heavy drinking and long-term use of sedatives, analgesics or anti-anxiety drugs;
- •Hearing and language impairment;
- •Peripheral vascular disease;
- •Severe cardiovascular disease or neurological disorders;
- •Failure of one-time peripheral venipuncture;
- •Infection of hand or wrist skin.
研究组 & 干预措施
Lidocaine pre-intravenous injection
The initial dose of lidocaine for pre-injection was set at 0.5mg /kg according to previous literature and preliminary test results. The dose of lidocaine was according to the patients' pain level. If there is no pain (negative reaction), the dose of lidocaine in the next patient will be reduced until the patient has pain. If there is pain (positive reaction), the dose of lidocaine will be increased in the next patient until the patient is painless.
干预措施: Lidocaine (Drug)
结局指标
主要结局
The appearance of intravenous injection pain
时间窗: through study completion, an average of 2 minutes
Yes or No
次要结局
- The levels of intravenous injection pain(through study completion, an average of 2 minutes)
- If any adverse memory or pain during the induction of general anesthesia(Before patients left the postanesthetic care unit (PACU))
研究者
Zhuan Zhang
Director
Yangzhou University