Comparison of 0.5% hyperbaric levobupivacaine with 0.5% hyperbaric levobupivacaine plus fentanyl in lower limb orthopaedic surgery under spinal anaesthesia.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- â—To study and compare the onset of analgesia, duration of sensory blockade , motor blockade, hemodynamics parameters ( SBP,DBP,MAP,HR) of 0.5% hyperbaric levobupivacaine and 0.5% hyperbaric levobupivacaine with fentanyl.
研究概览
简要总结
various clinical trials have found that administration of fentanyl with local anaesthetic in spinal anaesthesia prolonged the duration of sensory and motor blockade. however ,there are limited data available on comparing of fentanyl as adjunvant to levobupivacaine in spinal anaesthesia.so we want to compare whether adding fentanyl tolevobupivacaine for spinal anaesthesia would affect the sensory and motor blocks and duration of analgesia.the present work has been undertaken to study and compare the effect provided by fentanyl as adjuvants to levobupivacaine in spinal anaesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA GRADE 1 AND
- •SCHEDULED FOR ELECTIVE LOWER LIMB ORTHOPAEDICS SURGERIES UNDER SPINAL ANAESTHESIA.
排除标准
- •LACK OF PATIENTS CONSENT.
- •PATIENT REFUSALFOR SPINAL ANESTHESIA.
- •3.HISTORY OF SERIOUS PULMONARY DISEASE,ISCHEMIC HEART DISEASE,RENAL/HEPATIC DYSFUNCTION ,CORONARY ARTERY,OR CERVICAL SPINE DISEASE AND PATIENTS WITH ABNORMAL COAGULATION PROFILE.
- •PATIENTS WITH LOCAL SKIN SITE INFECTION.
- •5.PATIENTS WITH HYPERSENSTIVITY TO ANY OF THE DRUGS USED.
- •6.PREGNANT AND LACTATING MOTHERS.
结局指标
主要结局
â—To study and compare the onset of analgesia, duration of sensory blockade , motor blockade, hemodynamics parameters ( SBP,DBP,MAP,HR) of 0.5% hyperbaric levobupivacaine and 0.5% hyperbaric levobupivacaine with fentanyl.
时间窗: first 24 hour at immediately after block,at 5min,10min,15min,20 min,25min ,30 min,60 min,90min,120 min,180 min,240 min ,300min.
次要结局
- to compare the side effects of 0.5% hyperbaric levobupivacaine and 0.5% hyperbaric levobupivacaine with fentanyl.