Title: The Effect of Combined Ephedrine and Lidocaine Pretreatment on Pain Due to Propofol Injection in Patients Undergoing Elective Surgery Under General Anaesthesia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- pain during propofol injection is assessed by face pain scale(FPS) and verbal rating scale(VRS)
研究概览
简要总结
Objectives: Injection pain and hypotension are two main adverse effects of propofol which distresses patient. The aim of this prospective double blind study was to compare the effect of ephedrine -lidocaine combination with lidocaine and ephedrine on injection pain and hemodynamic changes due to propofol induction.
Methods: 165 adult patients, aged 20 to 60 yr, Patients were randomly allocated to one of 5 groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30microgram/kg (E30), ephedrine 70 microgram/kg(E70), lidocaine 0.5mg/kg -ephedrine 30 microgram/kg(LE) or 2ml saline (S) intravenously. After one minute propofol 2 mg/kg into a dorsal hand vein was injected. Face pain scale and verbal rating scale, arterial blood pressure and heart rate were recorded before induction, just before intubation, and one minute after intubation
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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with American Society of Anesthesiologists(ASA)physical statusIandII
排除标准
- •patients with difficulty in communication
- •history of allergic, neurologic or cardiovascular disease
- •patients who had received an analgesic medication within 24 hr before surgery
研究组 & 干预措施
ephedrine 30 microgram/kg
Patients were randomly allocated to one of 5
groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30micrograms/kg (E30)ephedrine 70micrograms/kg(E70),lidocaine0.5mg/kg -ephedrine30 micrograms/kg(LE) or 2ml saline (S)intravenously.participants in each group receive a single dose of the intervention treatment only.After one minute propofol 2 mg/kg into a dorsal hand vein was injected
干预措施: Ephedrine 30microgram/kg (Drug)
ephedrine 70 microgram/kg
Patients were randomly allocated to one of 5
groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30micrograms/kg (E30)ephedrine 70micrograms/kg(E70),lidocaine0.5mg/kg -ephedrine30 micrograms/kg(LE) or 2ml saline (S)intravenously.participants in each group receive a single dose of the intervention treatment only.After one minute propofol 2 mg/kg into a dorsal hand vein was injected
干预措施: ephedrine 70 microgram/kg (Drug)
lidocaine0.5mg/kg -ephedrine30 micrograms/kg
Patients were randomly allocated to one of 5
groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30micrograms/kg (E30)ephedrine 70micrograms/kg(E70),lidocaine0.5mg/kg -ephedrine30 micrograms/kg(LE) or 2ml saline (S)intravenously.participants in each group receive a single dose of the intervention treatment only.After one minute propofol 2 mg/kg into a dorsal hand vein was injected
干预措施: lidocaine0.5mg/kg -ephedrine30 micrograms/kg (Drug)
lidocaine 0.5mg/kg
Patients were randomly allocated to one of 5
groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30micrograms/kg (E30)ephedrine 70micrograms/kg(E70),lidocaine0.5mg/kg -ephedrine30 micrograms/kg(LE) or 2ml saline (S)intravenously.participants in each group receive a single dose of the intervention treatment only.After one minute propofol 2 mg/kg into a dorsal hand vein was injected
干预措施: lidocaine 0.5mg/kg (Drug)
normal saline 2ml
Patients were randomly allocated to one of 5
groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30micrograms/kg (E30)ephedrine 70micrograms/kg(E70),lidocaine0.5mg/kg -ephedrine30 micrograms/kg(LE) or 2ml saline (S)intravenously.participants in each group receive a single dose of the intervention treatment only.After one minute propofol 2 mg/kg into a dorsal hand vein was injected
干预措施: normal saline 2ml (Drug)
结局指标
主要结局
pain during propofol injection is assessed by face pain scale(FPS) and verbal rating scale(VRS)
时间窗: during the injection period of propofol(One minute after the administration of the test solution) before loss of consciousness
次要结局
- mean arterial blood pressure(before the administration of the test solution , just before intubation(three minutes after atracurium injection), and one minute after intubation)
- heart rate(before the administration of the test solution, just before intubation(three minutes after atracurium injection) , and one minute after intubation)
研究者
marzieh beigom khezri
Qazvine University Of Medical Sciences
Qazvin University Of Medical Sciences