Comparative evaluation of Dexmedetomidne and Tramadol for attenuation of post-spinal Anaesthesia shivering during lower limb surgeries: A Randomized Double-Blinded Study
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
- To compare the efficacy of IV Dexmedetomidine(0.5mcg/kg) and IV Tramadol(0.5mg/kg) for prevention of intraoperative shivering in patients undergoing lower limb surgeries under spinal anaesthesia.
研究概览
简要总结
Post-spinal anaesthesia shivering is a frequent complication that can cause discomfort for patients and lead to increased oxygen consumption, elevated carbon dioxide levels, lactic acid buildup, and difficulty in patient monitoring. Tramadol hydrochloride, a medication with central analgesic properties, has shown effectiveness in managing post-anaesthetic shivering following general and neuraxial anaesthesia. Dexmedetomidine, a potent alpha 2A-adrenergic receptor agonist, is used for sedation and has been found to lower the shivering threshold. Therefore, this research aims to assess the efficacy of Dexmedetomidine and Tramadol in preventing intraoperative shivering.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator 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
- •1.Patients aged between 18 to 60 yrs both male and female undergoing elective lower limb surgeries under spinal anaesthesia and reported shivering during surgery. 2.Belonging to American Society of Anaesthesiologists (ASA) Physical status I and II. 3.Patients whose BMI is in the range of
- •34.9 4.Patients who are willing to give consent to be a part of the study.
排除标准
- •1.Patients who do not develop shivering during surgery.
- •2.Patients with contraindications to regional anaesthesia.
- •3.Patients with history of hypersensitivity to amide local anaesthetics , dexmedetomidine and tramadol in the past.
- •5.Failure to decrease the shivering after repeated dosage more than 2 times.
- •6.Pregnant and lactating females.
- •7.Patients with hyperthyroidism, moderate to severe cardiopulmonary disease, hepatic failure psychiatric illness, renal failure, uncontrolled diabetes with autonomic neuropathy, severe bradycardia and hypotension.
- •8.Excessive hemorrhage needing transfusion .
- •9.Failure or incomplete spinal block.
- •10.Those with a known history of substance abuse.
结局指标
主要结局
To compare the efficacy of IV Dexmedetomidine(0.5mcg/kg) and IV Tramadol(0.5mg/kg) for prevention of intraoperative shivering in patients undergoing lower limb surgeries under spinal anaesthesia.
时间窗: Onset of sensory and motor blockade to be assessed every minute after giving Spinal Anaesthesia. | Onset of shivering will be assessed every 5 min until it subsides or till maximum of 180 minutes intraoperatively. | Total duration of shivering is assessed in each group in minutes.
Onset of shivering
时间窗: Onset of sensory and motor blockade to be assessed every minute after giving Spinal Anaesthesia. | Onset of shivering will be assessed every 5 min until it subsides or till maximum of 180 minutes intraoperatively. | Total duration of shivering is assessed in each group in minutes.
Severity of shivering
时间窗: Onset of sensory and motor blockade to be assessed every minute after giving Spinal Anaesthesia. | Onset of shivering will be assessed every 5 min until it subsides or till maximum of 180 minutes intraoperatively. | Total duration of shivering is assessed in each group in minutes.
Duration of shivering
时间窗: Onset of sensory and motor blockade to be assessed every minute after giving Spinal Anaesthesia. | Onset of shivering will be assessed every 5 min until it subsides or till maximum of 180 minutes intraoperatively. | Total duration of shivering is assessed in each group in minutes.
次要结局
- 1.To study the hemodynamic parameters of Dexmedetomidine & Tramadol.(2.To compare the adverse effects of Dexmedetomidine & Tramadol in the subjects.)
研究者
Dr Praveen Kumar DP
Rajiv Gandhi University of Health Sciences