Oral midodrine for preventing post-spinal anaesthesia hypotension in elderly: A randomized controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To compare the incidence post spinal anaesthesia hypotension with use of prophylactic oral midodrine vs placebo.
研究概览
简要总结
Title: Oral midodrine for preventing post- spinal anaesthesia hypotension in elderly: A randomized controlled trial.
Aim: To evaluate the efficacy of oral midodrine as prophylaxis against post- spinal hypotension.
Primary objective: To compare the incidence of post spinal anaesthesia hypotension with use of prophylactic oral midodrine versus placebo.
Secondary Objectives:
• To compare total volume of intravenous fluid infused in both group.
• To compare intraoperative ephedrine consumption in both group.
• To assess incidence of other complications like– bradycardia, pruritis, flushing, hypertension, shivering, nausea, vomiting etc in both group.
Inclusion criteria:- Adult patients aged 60 years or older of either sex, belonging to ASA Physical status I-II scheduled for below umbilical surgery under spinal anaesthesia will be included in the study.
Exclusion criteria:-
Patients with
• BMI> 30 kg/m2,
• Height < 130 cm,
• Spinal deformity,
• Uncontrolled Hypertension and Uncontrolled diabetes,
• Patients with Cardiac diseases,
• History of glaucoma,
• Liver disease and renal impairment,
• Contraindications of spinal anesthesia,
• Anticipated surgical duration more than 120 mins.
• Non-compliance,
• Refusal to participate.
• Hyperthyroidism.
Sample size: 80 patients (40 in each group)
Group allocation: Group midodrine(n=40) will receive oral tab midodrine 5mg, 90mins before spinal anaesthesia.
Group control(n=40) will receive oral tab thiamine 100mg, 90mins before spinal anaesthesia.
Assessment: 1. Incidence of post spinal anaesthesia hypotension.
2.Total volume of IV fluid infused.
. 3. Intraoperative ephedrine consumption.
. 4. Incidence of other complications
Analysis: Data will be compiled, and appropriate statistical test will be applied for the result..
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Double
入排标准
- 年龄范围
- 60.00 Year(s) 至 95.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients aged 60 years or older of either sex, belonging to ASA physical status I-II scheduled for below umbilical surgery under spinal anaesthesia will be included in the study.
排除标准
- •Patients with: spinal deformity, uncontrolled hypertension and diabetes, cardiac diseases, history of glaucoma, refusal to participate, non-compliance, liver disease and renal impairment, hyperthyroidism, anticipated surgical duration more than 120 mins.
结局指标
主要结局
To compare the incidence post spinal anaesthesia hypotension with use of prophylactic oral midodrine vs placebo.
时间窗: Post spinal anaesthesia at 0, 2,4,6,8,10,15,20,25,30,35,40,45,60,75,90,105 and 120 minutes.
次要结局
- 1.To compare total volume of IV fluid infused in both group.(2.To compare intraoperative ephedrine consumption in both group.)
研究者
Dr Tarun Yadav
Pt BDS PGIMS Rohtak