Effect of Mild Sedation and Analgesia on Radial Artery Cannulation in Novice Residents: a Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Overall success rate
研究概览
简要总结
The aim of this study is to conduct a prospective, single-center randomized controlled study to investigate the effect of mild midazolam combined with sufentanil on radial artery cannulation in novice operators.
详细描述
outcome: patients discomfort，visual analogue scale，First-attempt success rate，the success rate of radial artery cannulation within 10 minutes, Complication rate
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who required arterial cannulation for continuous blood pressure monitoring
- •Aged >20years
- •ASA physical status of 1-3
- •BMI 18-28kg/m2
- •All patients agreed to participate in this study at the time of recruitment and signed an informed consent form.
排除标准
- •a positive Allen's test
- •infection at the puncture site
- •coagulation disorders; arterial diseases (such as Raynaud's disease or thromboangiitis obliterans)
- •use of vasoactive drugs within 30 minutes before measurement during the study
- •patients with arterial abnormalities and bends; hemorrhagic shock
- •arterial atherosclerosis; radial artery puncture within the past 30 days
- •chronic use of opioid or benzodiazepine drugs
- •and known allergies or adverse reactions to benzodiazepines or opioids.
研究组 & 干预措施
mild sedation and analgesia
Intravenous injection of 0.1ug/kg sufentanil and 0.03mg/kg midazolam for sedation and analgesia before radial artery cannulation.
干预措施: mild sedation and analgesia (Drug)
control
Intravenous injection of an equivalent volume of saline before radial artery cannulation.
干预措施: control (Drug)
结局指标
主要结局
Overall success rate
时间窗: During radial artery cannulation (up to 1 hour)
success rate of puncture and catheter placement within 10 minutes.
次要结局
- patients discomfort(During radial artery cannulation (up to 1 hour))
- visual analogue scale(During radial artery cannulation (up to 1 hour))
- First-attempt success rate(During radial artery cannulation (up to 1 hour))
- Complication rate(postoperative 1 day and 3 day)
研究者
Qing-he Zhou
Principal investigator
Affiliated Hospital of Jiaxing University