Comparative evaluation of effects of iv dexmedetomidine and tramadol on shivering in patients undergoing orthopedic surgery under subarachnoid block
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- First of all base line spo2 , NIBP , temp , pulse rate and shivering score will be recorded than before the administration of drug and just after drug administration,after that at 5 minutes , 10 minutes , 15 minutes and at 30 minutes all the vitals and shivering score will be recorded.
研究概览
简要总结
A prospective , randomized and double blinded study will be conducted in 70 patients of either sex of age 18-50 years ,belonging to American Society of Anesthesiologists (ASA) physical status I or II scheduled for lower limb orthopedics surgery under spinal anesthesia .Patients with history of hypo or hyperthyroidism , history of cardiopulmonary disease , history of blood transfusion , history of psychological disorders , having initial body temperature above 38.00c or below 36.00c , HR less than 50bpm, systolic BP less than 100 mmHg , History of allergy from dexmedetomidine or NSAIDS and patients refused to participate in study will be excluded from the study . Patients will be randomly allocated on the basis of sealed envelope technique based on a computer generated list to receive one of the following drug after having shivering because of spinal anesthesia. Group A will receive dexmedetomidine 0.5mcg/kg and Group B will receive Tramadol 0.5mg/kg . Patients will be prepared and given spinal anesthesia Patients heart rate , blood pressure , oxygen saturation , temperature, shivering grading will be recorded. We will compare both drugs and will record which drug is better in outcome and will also note any side effects like headache, allergy, hypotension, bradycardia, difficulty in micturition and nausea and vomiting. Data will be collected and compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •The present study will include 70 patients of either sex of age 18 to 50 years , belonging to ASA physical status 1 or 2 scheduled for lower limb surgery under spinal anesthesia.
排除标准
- •Obesity , History of hypo or hyperthyroidism, History of cardiopulmonary disease , History of blood transfusion , History of psychological disorders , body temp above 38C and below 36C , HR Less than 50, Systolic BP less than 50 , History of allergy from dexmedetomidine or NSAIDS , Refusal from patients.
结局指标
主要结局
First of all base line spo2 , NIBP , temp , pulse rate and shivering score will be recorded than before the administration of drug and just after drug administration,after that at 5 minutes , 10 minutes , 15 minutes and at 30 minutes all the vitals and shivering score will be recorded.
时间窗: At baseline , just before and after the drug administration, at 5 minutes ,10 minutes , 15 minutes and at 30 minute intervals all vitals and shivering score will be assessed
次要结局
- All the vitals including spo2 , NIBP,HR, Temp, shivering score will be assessed(At baseline , just before & after the drug administration, at 5 minutes, 10 minutes, 15 minutes & at 30 minutes intervals all will be assessed)
研究者
DR NANDITA KAD
PT BD SHARMA PGIMS ROHTAK