Comparative Study on Fractionated Versus Bolus Dose of Hyperbaric Bupivacaine in Patients Undergoing Transurethral Resection of Prostate Surgery Under Subarachnoid Block.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Comparision of mean arterial pressure(MAP) in both participants with subarachnoid block
研究概览
简要总结
The goal of this study is to compare the intraoperative hemodynamic status, characteristics of block of fractionated versus single bolus dose of Hyperbaric Bupivacaine in patient undergoing Transurethral Resection of Prostate(TURP) surgery under Subarachnoid block(SAB).
Seventy-two patients aged 50 years and above belonging to American Physical status I and II are divided into two study group.
Group B will receive Injection 0.5 % hyperbaric bupivacaine 2.5 ml single bolus dose and group F will receive same concentration and volume of hyperbaric bupivacaine with two third dose initially (i.e. 1.6 ml) and remaining one third dose (i.e. 0.9 ml) after 60 seconds at the rate of 0.2ml/sec.
详细描述
The aim of this study is to compare the intraoperative hemodynamic status, characteristics of block of fractionated versus single bolus dose of Hyperbaric Bupivacaine in patient undergoing TURP surgery under SAB.
Seventy-two patients aged 50 years and above belonging to American Physical status I and II undergoing transurethral resection of prostate for benign enlargement of prostate under subarachnoid block are enrolled and are divided into two groups having 36 patients in each.
Group B will receive Injection 0.5 % hyperbaric bupivacaine 2.5 ml single bolus dose and group F will receive same concentration and volume of hyperbaric bupivacaine with two third dose initially (i.e. 1.6 ml) and remaining one third dose (i.e. 0.9 ml) after 60 seconds at the rate of 0.2ml/sec.
Intraoperative mean arterial pressure (MAP), heart rate, onset of sensory and motor block, duration of sensory and motor block, and total intraoperative consumption of vasopressor are observed and compared between 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age: 50 years and above patients undergoing TURP surgery under SAB
- •American Society of Anesthesiologist's Physical Status: I and II.
排除标准
- •Patients with history of uncontrolled hypertension.
- •Patients with previous history of cerebrovascular accidents.
- •Patients with history of spinal deformity.
- •Patients with known allergy to local anesthetics.
- •Patient with Infection at site of injection.
- •Patient with history of coagulopathy.
研究组 & 干预措施
Bolus arm group
In this group ,participants are given Injection Heavy Bupivacaine 0.5% 2.5ml bolus at a rate of 0.2ml/hr
干预措施: 0.5% Heavy Bupivacaine (Combination Product)
Fractionated group arm
In this group ,participants are given 1.6 ml of Injection Heavy Bupivacaine 0.5% initially followed by 0.9ml after 60 seconds at a rate of 0.2ml/hr.
干预措施: 0.5% Heavy Bupivacaine (Combination Product)
结局指标
主要结局
Comparision of mean arterial pressure(MAP) in both participants with subarachnoid block
时间窗: Throughout study completion,an average of 3 months
Hypotension was defined when mean arterial pressure (MAP) decreased ≤20% from baseline.
Comparision of heart rate in both participants with subarachnoid block
时间窗: Throughout study completion,an average of 3 months
Bradycardia was defined when heart rate is less than 60 beats per minute.
Comparision of total consumption of vasopressors used during intraoperative period between the groups.
时间窗: Throughout study completion,an average of 3 months
Injection Mephentermine 6mg iv was given for hypotension
次要结局
- Comparision of the time of regression motor block between two groups.(Throughout study completion,an average of 3 months.)
- Comparision of adverse effects like nausea, vomiting and shivering between the groups(Throughout study completion,an average of 3 months.)
- Comparision of time for onset of sensory between the groups.(Throughout study completion,an average of 3 months.)
- Comparision of time for onset of motor block between the groups(Throughout study completion,an average of 3 months.)
- Comparision of the time of regression of sensory block between two groups.(Throughout study completion,an average of 3 months)
研究者
Shushma K C
Doctor
National Academy of Medical Sciences, Nepal