Low Epidural Anesthesia With Chloroprocaine Versus Lidocaine: a Prospective, Randomized, Double-blinded Multi-centre Clinical Trial in China
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 主要终点
- Epidural anesthesia effects of chloroprocaine versus lidocaine
研究概览
简要总结
Chinese made chloroprocaine has a rapid onset time, effective methodology, can last for a short time, provides fast motor recovery and causes no significant side effects.
详细描述
Chloroprocaine hydrochloride is the chloridized local anesthetic of procaine hydrochloride, with twice the anesthetic intensity, four to five times the metabolization and half the side effect of procaine. The chloroprocaine hydrochloride product made in China has been on sale since 2002. To determine the clinical efficacy of low-epidural anesthesia with chloroprocaine versus lidocaine, the investigators carried out a prospective, randomized, double-blinded multi-centre clinical trial. The results demonstrate that epidural anesthesia using chloroprocaine has a more rapid onset time and shorter duration than with lidocaine. It can also provide a reliable sensory and motor block in epidural anesthesia, and is thus a more attractive alternative than lidocaine for middle and short duration surgical procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Weight no more than 80 Kg or not more than 20% of normal weight
- •American Society of Anesthesiologists (ASA) grade I or II
- •No obstacles in thinking or language communication
- •No epidural puncture contraindications such as disturbances of blood coagulation, local infection of the puncture site or use of anticoagulants
排除标准
- •Chronic obstructive pulmonary diseases
- •Serious heart, liver, renal and metabolic diseases
- •Cerebral thrombosis and sequela
- •Serious dehydration and electrolyte imbalance
- •Neuromuscular diseases
- •Pregnant or parturient women
- •Abnormal liver and kidney function
研究组 & 干预措施
Lidocaine Group
Epidural anesthesia with 2% lidocaine.
干预措施: Lidocaine (Drug)
Chloroprocaine Group
Epidural anesthesia with 3% chloroprocaine.
干预措施: Chloroprocaine (Drug)
结局指标
主要结局
Epidural anesthesia effects of chloroprocaine versus lidocaine
时间窗: Four months (January - April, 2008)
The effects of epidural anesthesia are assessed by onset time of epidural block, pain free and recovery time, the upper block level and time, the degree of muscle relaxation, and motor recovery time.
次要结局
- Comparison of vital signs between chloroprocaine and lidocaine groups(Four months (January - April, 2008))
研究者
Haibin Dai
Attending Doctor of Department of Anesthesiology
Jinling Hospital, China