Comparison of Incidence of Hemodynamics and Block Characteristics Between Height Based Versus Conventional Fixed Dose Spinal Anesthesia in Lower Limb Surgeries: a Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 104
- 主要终点
- Hypotension and Bradycardia
研究概览
简要总结
This study aim is to compare height based dose of spinal anesthesia vs conventional dose. Hypothesis is height based dose has less hemodynamics changes compared to conventional dosing.
详细描述
This is a prospective, randomized, double blinded, controlled trial with minimum 6 months of data collection. Patients will be divided into two groups randomly. Group H and C each having 52 patients. Groups H will be given spinal anesthesia dose according to their height by pre determined dosing algorithm. Group C will be given a fixed dose of Hyperbaric Bupivacaine 0.5% 12.5mg (2.5ml) without adjusting it according to their height. Pateint's blood pressure and Heart rate along with sensory effect will be recorded 5,10 and 15 minutes later after spinal anesthesia. I will be recording any episode of bradycardia and hypotension and intervention needed to treat it in both the groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •both genders. 18-65 years age ASA physical status I and II
排除标准
- •ASA III and IV Refusal of patient Height less than 150 cm Known allergy to study drug
研究组 & 干预措施
height based spinal anesthesia dose
Height based dose
干预措施: Height based dose of hyperbaric bupivacaine 0.5% (Drug)
Conventional dose of spinal anesthesia
Conventional dose of hyperbaric bupivacaine 0.5%
干预措施: Height based dose of hyperbaric bupivacaine 0.5% (Drug)
结局指标
主要结局
Hypotension and Bradycardia
时间窗: 6 months
Icidence of hypotension and bradycardia
时间窗: 6 months
次要结局
未报告次要终点
研究者
Zuniara Siddqui
Principal investigator
Liaquat National Hospital & Medical College
