A Comparative Study Of Intravenous Dexmedetomidine with Intravenous Tramadol For Treatment Of Post Spinal Anaesthesia Shivering In Patients For Elective Lower Limb Surgeries
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Post Spinal Anaesthesia Shivering
研究概览
简要总结
Shivering Is One Of The Consequences Of Peri operative Hypothermia. It Occurs Frequently After Giving Subarachnoid Block.
Various Clinical Trail Have Been Done On The Administration Of Dexmedetomidine And Tramadol In Post Operative Spinal Anaesthesia Shivering. However Very Limited Data Is Available On Their Comparison. Considering The Low Side Effect And Excellent Post Operative Analgesic Efficacy Of Two Drugs.It Is Essential To Carry Out A Comparative Evaluation Of Two Drugs.
The Study Will Be Carried Out In 200 Patients And The Participants Will Be Randomized Into 2 Groups Of 100 Patients Each.Randomization Will Be Carried Out Using Generated Random Numbers And Sealed Envelop Technique Such That
A Group D
Patients Receiving Intravenous Dexmedetomidine 0.5 mcg/Kg Diluted In 10 ml Of NS given As Infusion Over 10 Min.
B Group T
Patients Receiving Intravenous Tramadol 0.5 mg/Kg Diluted In 10 ml Of NS Given As Infusion Over 10 Min.
The Presence Of Shivering Will Be Observed And Graded From 0 To 4 Using Bed Side Shivering Assessment Scale. Where 0 Indicated No Shivering And 4 Indicated Shivering All Over Body.
Degree Of Sedation Will Be Assessed According To Ramsay Sedation Score Where 1 Indicated That The Patient Is Anxious And Agitated Or Restless And Highest Score Of 6 Indicated That Patient Exhibits No Responce. After The Occurence Of Shivering Study Drugs Will Be Given And Their Effects And Side Effects Will Be Noted And Details Will Be Recorded In Patient Proforma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Age 18-20 Years ASA Grade I And II Patients Presented With Shivering Posted Under Orthopaedic Lower Limb Surgery Under Subarachnoid Block.
排除标准
- •Patients Refusal Age Less Than 18 Years And More Than 60 Years ASA Grade III And More Bradycardia.
结局指标
主要结局
Post Spinal Anaesthesia Shivering
时间窗: Post Spinal Anaesthesia Shivering Will Be Assessed Using Bedside Shivering Assessment Scale For 180 Minutes
次要结局
- Degree Of Sedation(Degree Of Sedation Will Be Assessed Using Ramsay Sedation Scale For 180 Minutes)
研究者
Dr Prashant Yadav
Peoples College Of Medical ScienceAnd Research Centre