Comparative study of intravenous tramadol versus ketamine on shivering among patients undergoing spinal anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Shivering incidence and Shivering score
研究概览
简要总结
Shivering is a common and distressing complication following spinal anaesthesia with an incidence ranging from 40 to 60 percent. It causes patient discomfort and can lead to increased oxygen consumption interference with monitoring and hemodynamic instability. In routine anesthetic practice various pharmacological agents are already used for prevention of post spinal shivering most commonly ketamine and tramadol. However previous studies have shown inconsistent results regarding their comparative effectiveness and side effect profiles. This prospective observational study will compare patients who receive prophylactic low dose ketamine prophylactic tramadol or no prophylactic medication which is also a standard practice followed by some anesthesiologist. Since these drugs are already administered in routine care at our hospital the study will only involve systematic observation and documentation of their effects without altering patient management. The primary objective is to compare the incidence and severity of shivering after spinal anesthesia across the three groups. Secondary objectives include assessment of intraoperative hemodynamic changes and other adverse effects associated with ketamine and tramadol
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients aged 20 to 60 years scheduled for elective surgery under subarachnoid block, American Society of Anesthesiologists Physical Status 1 or 2, Willingness to provide informed consent for participation in the study.
排除标准
- •Known allergy or hypersensitivity to ketamine or tramadol, Absolute contraindication for subarachnoid blockade, Patient with baseline core temperature greater than 37.5°C or less than 35.5°C, Patient denial, patient with any psychological condition.
结局指标
主要结局
Shivering incidence and Shivering score
时间窗: As primary outcome patient shivering score will be measured throughout the surgery at 10min interval until end of the surgery
次要结局
- Sedation Score , incidence of any adverse events like nausea and vomiting , hemodynamic changes like blood pressure, heart rate and SPO2(Sedation score and adverse events will be measured throughout the surgery at 10min interval until end of the surgery. Hemodynamics, baseline values will be noted first followed by every 5 mins for the first 30 mins post spinal anesthesia and every 15 minutes until end of the surgery)
研究者
DIVYA MARIA MATHEW
Kasturba Medical College, Manipal