A comparison bwtween levobupivacaine with Dexmedetomidine versus levobupivacaine with clonidine in labour analgesia
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- compare Analgesic efficacy of dexmedetomidine and clonidine based on VAS score
研究概览
简要总结
Epidural analgesia is the most commonly used method of labour analgesia. The mainstay of use is that it provides maximum analgesia with minimum motor blockade. Of all the drugs used, bupivacaine is the most commonly used local anesthetic used. However its potential for motor blockade as made space for the use of adjuvants that help decrease the dose And concentration of local anesthetic used without any decrease in the analgesic action. The search for the ideal adjuvant has lead to the study of alpha agonists such as clodinine and dexmedetomidine. Dexmedetominde is a highly selective alpha 2 agonist that has analgesic and sedative properties. When added to local anesthetic agents it enhances their effect without increasing the side effects. It is lipophilic and hence has less propensity to cross the placenta and enter into foetal circulation. Though at present approved for iv use, it has successfully been used for epidural block and labour analgesia in clinical studies.
Clonidine is also an alpha agonist that have good analgesic action. It has previously been used for labour analgesia in humans bit there has been no prior study rhat has compared the efficacy of the 2 drugs.
Hence the purpose of my study is to compare the efficacy of the drugs, clonidine and dexmedetomidine when used as adjuvants for labour analegsia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •ASA grade I,II Full terrm Primigravida Singleton pregnancy with vertex presentation.
排除标准
- •Pre-eclampsia, eclampsia Thyroid disease Diabetes Heart disease Twin pregnancy.
结局指标
主要结局
compare Analgesic efficacy of dexmedetomidine and clonidine based on VAS score
时间窗: VAS At 0, 5, 10 15, 30, 45, 60 minutes and then every half hour until delivery
次要结局
- Compare motor effect by Bromage score(At 0, 5, 10 15, 30, 45, 60 minutes and then every half hour until delivery)
- Haemodynamic effects- Heart rate, systolic BP, diastolic BP, mean arterial pressure, spo2(At 0, 5, 10 15, 30, 45, 60 minutes and then every half hour until delivery)
- Time of onset of analgesia, quality of analgesia, nature of Expulsive efforts, Type of delivery(At end of delivery)
- Maternal side effects(At end of labour)
- Neonatal outcome, Apgar score(At 1 and 5 minutes after delivery)