COMPARISON OF FRACTIONATED WITH BOLUS DOSE OF ZERO POINT FIVE PERCENT HYPERBARIC BUPIVACAINE IN SPINAL ANAESTHESIA FOR PATIENTS UNDERGOING LOWER LIMB ORTHOPAEDIC SURGERIES
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Haemodynamic changes [Mean Arterial Pressure (MAP), Non Invasive Blood Pressure
研究概览
简要总结
This study is a comparative randomised double blind study of fractionated with bolus dose of 0.5% hyperbaric bupivacaine with 25 mcgs Fentanyl in spinal anaesthesia for patients undergoing lower limb orthopaedic surgeries. The objective of the study is to compare the haemodynamic changes at different time intervals , onset and duration of sensory and motor block , duration of analgesia till the first request for rescue analgesics and side effects seen among the two groups . Total 60 patients will be randomly selected which belongs to ASA I-III . 60 patients will be divided into two groups 30 in each group by using sealed envelope technique . One group will recieve drug as bolus and other will recieve drug in fractionated manner. The drug will be given to all patients using 25 G Quincke’s spinal needle in sitting position.
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 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Physical status I-III according to American Society of Anesthesiologists 2) Willing for spinal anaesthesia 3) Patients undergoing lower limb orthopaedic surgeries 4) BMI less than 35.
排除标准
- •Absolute contraindications of spinal anaesthesia such as localized infection at injection site, patient’s inability to position during the procedure , patient’s refusal, allergy to anaesthetic drugs, increased intracranial pressure 2) Relative contraindication to spinal anaesthesia such as myelopathy or peripheral neuropathy, spinal stenosis, history of spinal surgery, spinal deformities, multiple sclerosis, spina bifida, aortic stenosis , altered mental status & coagulopathies.
- •BMI equal to or more than 35 4) Ineffective block with conversion to general anaesthesia.
结局指标
主要结局
Haemodynamic changes [Mean Arterial Pressure (MAP), Non Invasive Blood Pressure
时间窗: The heart rate and blood pressure will be monitored at base line, just before subarachnoid block then at 5,10,15,20,40,60,80,100,120 mins and thereafter every | 20 mins till the duration of surgery after giving spinal anaesthesia.
(NIBP) & Heart Rate (HR)] at different time intervals.
时间窗: The heart rate and blood pressure will be monitored at base line, just before subarachnoid block then at 5,10,15,20,40,60,80,100,120 mins and thereafter every | 20 mins till the duration of surgery after giving spinal anaesthesia.
次要结局
- 1)Onset and duration of sensory and motor block using pinprick test and modified Bromage scale(2)Duration of analgesia till the first request for rescue analgesic using VAS pain score)