Esmolol Pretreatment on Pain During Injection of Propofol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Pain on injection of propofol
研究概览
简要总结
Pain on injection of propofol is a common side effect. The present study was designed to investigate the effect of esmolol on pain on propofol injection and to compare it with remifentanil and placebo.
详细描述
In a double-blind, prospective trial, 120 patients scheduled to undergo elective surgery were randomized to receive normal saline (n=30), remifentanil 0.35 μg/kg (n=30), esmolol 0.5 mg/kg (n=30), or Esmolol 1mg/kg (n=30) as pretreatment. Thirty seconds after pretreatment, 25% of the total calculated dose of propofol (2 mg/kg) was administrated into a dorsal hand vein. Ten seconds after propofol had been given at the rate of 0.5 ml/sec pain was assessed on a four-point scale (0=none, 1 = mild, 2= moderate, 3= severe).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 19-60 years, American Society of Anesthesiologists (ASA) physical status I and II, scheduled for elective surgery under general anesthesia
排除标准
- •Patients with cardiovascular, neurological or psychiatric disorder problem, patients who received the analgesic or sedative medications within the last 24 hours, and pregnancy were excluded
研究组 & 干预措施
Placebo & propofol
Pretreatment with normal saline before injection of propofol
干预措施: Normal saline (Drug)
Placebo & propofol
Pretreatment with normal saline before injection of propofol
干预措施: propofol (Drug)
esmolol 0.05 mg/kg & propofol
Pretreatment with esmolol 0.05 mg/kg before injection of propofol
干预措施: Esmolol (Drug)
esmolol 0.05 mg/kg & propofol
Pretreatment with esmolol 0.05 mg/kg before injection of propofol
干预措施: propofol (Drug)
esmolol 1 mg/kg & propofol
Pretreatment with esmolol 1 mg/kg before injection of propofol
干预措施: Esmolol (Drug)
esmolol 1 mg/kg & propofol
Pretreatment with esmolol 1 mg/kg before injection of propofol
干预措施: propofol (Drug)
remifentanil 0.35 ug/kg & propofol
Pretreatment with remifentanil 0.35 ug/kg before injection of propofol
干预措施: Remifentanil (Drug)
remifentanil 0.35 ug/kg & propofol
Pretreatment with remifentanil 0.35 ug/kg before injection of propofol
干预措施: propofol (Drug)
结局指标
主要结局
Pain on injection of propofol
时间窗: 10 seconds after injection of 25% of the total calculated dose of propofol (2 mg/kg)
Thirty seconds after pretreatment, 25% of the total calculated dose of propofol (2 mg/kg) was administrated into a dorsal hand vein. Ten seconds after injection of propofol, pain was assessed on a four-point scale (0=none, 1 = mild, 2= moderate, 3= severe).
次要结局
未报告次要终点
研究者
Younghoon Jeon
Associate Professor
Kyungpook National University Hospital