Comparing efficacy of two doses of preoperative oral midodrine for preventing hypotension after spinal anaesthesia during lower limb orthopaedic surgeries A Randomized controlled trial
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Incidence of post spinal anesthesia hypotension defined as systolic blood pressure less than ninety mmHg or a decrease of mean arterial pressure more than twenty percent from baseline
研究概览
简要总结
Spinal anesthesia is a form of neuraxial block
Hypotension is the most common complication
Midodrine it is an alpha one agonist drug which is arteriolar and venous vasocontriction leads to increase in systolic blood pressure
Previous studies of oral midodrine for prevention of hypotension after spinal anesthesia it has shown promising results
Different Studies was done with different dose of oral midodrine and placebo
In this study we wish to compare two doses of oral midodrine to known the effective dose in preventing hypotension after spinal anaesthesia with minimal side effects
It is randomized double blind study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 18-65 years Patients scheduled for elective lower limb orthopedic surgery under spinal anesthesia BMI 35kg per m2 American Society of Anesthesiologists ASA physical status I and II Willingness to participate and provide written informed consent.
排除标准
- •Contraindications to spinal anesthesia like coagulopathy and infection at the puncture site Contraindications to midodrine like pheochromocytoma and severe heart disease Patients with a history of significant cardiovascular disease like heart failure and uncontrolled hypertension Patients with renal or hepatic impairment Patients taking medications that may interact with midodrine like alpha-adrenergic agonists and MAO inhibitors Pregnancy or lactation Patients with a known allergy to midodrine.
结局指标
主要结局
Incidence of post spinal anesthesia hypotension defined as systolic blood pressure less than ninety mmHg or a decrease of mean arterial pressure more than twenty percent from baseline
时间窗: After spinal anesthesia every 2 mins for initial 20 mins then every 5 mins till end of surgery
次要结局
- Number of hypotensive episodes(Severity of hypotension after spinal anaesthesia like duration of hypotensive episodes and lowest systolic blood pressure or Mean Arterial Pressure)
研究者
Beepata Avanthika
AIIMS Gorakhpur