A Comparison of Lidocaine, Esmolol, and Placebo Without Use of a Tourniquet for Relieving Pain From Intravenous Administration of Propofol
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Patient Pain Score
研究概览
简要总结
The primary hypothesis is that esmolol and lidocaine, when given without the use of a tourniquet, provide relief of propofol injection pain that is superior to placebo when assessed using the propofol pain scoring tool
详细描述
The study will include three arms: lidocaine, esmolol, and placebo. Eligible patients will be 18-60 years old, ASA physical status 1-3, and scheduled for an elective surgical procedure. Patients will be randomized to receive lidocaine, esmolol, or placebo. Both the patients and the administering/observing providers will be blinded to the study drug or placebo being administered
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
- Double (Participant, Care Provider)
盲法说明
assessor asking for pain scores will be blinded from the randomization
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-60 years of age
- •Elective surgical procedure
排除标准
- •Pregnancy
- •Requirement for RSI or awake intubation
- •Suspected or known difficult airway
- •Contraindication to IV in either upper extremity
- •Chronic pain syndrome including fibromyalgia
- •Use of opioids, NSAIDs, or other analgesics within 24 hours (including preoperative PO Celebrex, Lyrica, Tylenol, etc.)
- •Any use of opioids in the past three months
- •Significant cardiopulmonary or hepatic dysfunction
- •Hypersensitivity to study medications
研究组 & 干预措施
Lidocaine
1 mg/kg lidocaine to a max of 100 mg
干预措施: Lidocaine (Drug)
Esmolol
0.5 mg/kg esmolol to a max of 50 mg
干预措施: Esmolol (Drug)
Placebo
Saline water
干预措施: Placebo (Other)
结局指标
主要结局
Patient Pain Score
时间窗: following administration of a sub-induction dose of propofol, 0.5 mg/kg up to 50 mg, just prior to full induction
pain scoring system previously used by studies looking at various remedies to decrease Propofol injection pain - 0-10 with 0=no pain up to 10=worst pain imaginable
次要结局
- Oxygen Saturation Percentage(Oxygen saturation measured each minute for the first 10 minutes following induction)
- Heart Rate(heart rate is measured each minute for the first 10 minutes following induction)
- Systolic Blood Pressure(Systolic Blood Pressure is measured each minute for the first 10 minutes following induction)