A Single-center, Randomized and Controlled Clinical Research Projects
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Success ratio of first radial artery puncture
研究概览
简要总结
Objective: To investigate the effect of lidocaine injection location on the success rate of ultrasound-guided radial artery catheterization in a single-center, randomized, controlled clinical trial.
详细描述
Group A was randomly divided into two groups: 1% lidocaine 1 ml was injected above the artery during local anesthesia before arterial catheterization; Group B: 1ml of 1% lidocaine was injected into the right side of the artery. The proportion of subjects according to the number of PO was similar in all groups. After the screening, the scientific research personnel of each testing center will log in the random system, fill in the screening information, obtain the random number information, and distribute the corresponding scientific research drugs according to the random number. The total number of drugs is imported into the centralized random grouping system by generating random number by SAS software. The study was conducted by an evaluation researcher and a medication management researcher. Throughout the experiment, not only the subjects turned a blind eye, but also the evaluators turned a blind eye. This study set up evaluation investigators and administrative investigators. Administrative researchers were only involved in the randomization, allocation, and delivery process. Other procedures, including informed consent, screening, efficacy index and safety evaluation, and planned visits, were completed by the evaluation investigators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA Class I-III, patients aged 18-80 years
- •Planned surgery with radial artery catheterization
- •Allen test negative
- •Sign the informed consent form and voluntarily participate in this trial
排除标准
- •Inflamed skin at puncture site
- •Extremely nervous and unable to cooperate
- •Ultrasonographic assessment of aberrant radial artery
- •Significant abnormalities in coagulation function (PT prolongation exceeding the upper limit of normal for 3 s or APTT prolongation exceeding the upper limit of normal for 10 s)
- •The patient had undergone radial artery catheterization in the same arm in the past week
- •History of hypersensitivity to local anesthetics
研究组 & 干预措施
Superior group of radial artery
Injection of 1% lidocaine 1 ml above the artery
干预措施: Superior radial artery (Diagnostic Test)
Right radial artery group
Injection of 1% lidocaine 1 ml to the right side of the artery
干预措施: Right side of radial artery (Diagnostic Test)
结局指标
主要结局
Success ratio of first radial artery puncture
时间窗: Day 1
What is the probability of success the first time?
次要结局
- Before and after lidocaine local anesthesia, the radial artery longest diameter and shortest diameter, circumference, cross-sectional area and depth changes(Day 1)
研究者
Ting Xu
Chief physician
Sichuan Provincial People's Hospital
