Comparison of prophylactic use of three combinations of Ketamine, Midazolam and Pethidine for prevention of shivering during regional anaesthesia.
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 1.Incidence and grading of intraoperative shivering.
研究概览
简要总结
Shivering is a common complaint after spinal anaesthesia. It has potential hazards. So in my thesis I aim to prevent post spinal anaesthesia shivering by using 3 drug combinations which includes Ketamine, Pethidine, Midazolam in one group; Ketamine and Midazolam in the second group ; Pethidine and Midazolam in the third group. I will be comparing the efficacy of each group In preventing the same. At the same time also compare incidence of adverse effects in each group. I will be measuring the body core temperature = tympanic temperature and skin surface temperature = axillary temperature.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA physical status 1 and 2 patients who are scheduled for elective lower abdominal and lower limb surgeries under spinal anaesthesia.
排除标准
- •Patient refusal, Severe systemic disorders like diabetes mellitus, hypertension, cardiopulmonary disease, etc.
- •Body mass index of ≥30 kg/m2, Known history of alcohol or substance abuse.
- •Renal insufficiency, Peptic ulcer disease, Thyroid disease, Psychiatric disorder, Pregnancy, Acute infections e.g. upper respiratory tract infection or urinary tract infection etc., and fever due to any other cause.
- •Allergy to any of the study drugs and all known contraindications to spinal anaesthesia.
结局指标
主要结局
1.Incidence and grading of intraoperative shivering.
时间窗: After spinal anaesthesia, every 10 minutes for 60 minutes
2. Core body temperature and body surface temperature
时间窗: After spinal anaesthesia, every 10 minutes for 60 minutes
次要结局
- 1.Measurement of vital signs- HR, Blood pressure, Mean arterial pressure, SPO2.(2. Adverse effects- hypotension, hallucination, nausea and vomiting)