Comparison of Hemodynamic Stability With 0.75 vs 0.5percent Hyperbaric Bupivacaine During Spinal Anesthesia in Cystoscopic Procedures:A Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Measurement of frequency and mean changes in systolic blood pressure and heart rate
研究概览
简要总结
Purpose:The aim of this study is to determine the intrathecal Bupivacaine concentration(0.5% vs 0.75%) with better anesthesia and little hemodynamic disturbance during cystoscopic procedures.In comparing these bupivacaine concentrations ,the result would be expected to enhance safer spinal anesthesia practices ,minimizing the use of vasopressors in urological surgeries.OBJECTIVE:To compare and analyze the frequency and average chages of post spinal hemodynamic instability in terms of hypotension and bradycardia with 0.75% hyperbaric bupivacaine and 0.55 hyperbaric bupivacaine in patients presenting for cystoscopic procedures.
详细描述
OPERATIONAL DEFINITIONS:
Hemodynamic instability:This refers to systolic blood pressure heart rate shifts of 20% more or less from baseline value after spinal anesthesia.The hemodynamic instability will be evaluated both as a numerical change and categorical variable.
Hypotensin:A qualitative variable,defined as greater than 20% drop in baseline systolic blood pressure or systolic blood pressure of less than 90mmhg after spinal anesthesia.it will be recorded for each patient as present/absent.
Bradycardia:A qualitative variable,defined as heart rate below 60 beats per minute or greater than 20% drop in baseline heart rate after spinal anesthesia.it will be recorded for each patient as present /absent.
Hyperbaric bupivacaine:Local anesthetic mixed with dextrose to increase its density more than CSF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-80 years. American society of Anesthesiologist(ASA) physical status I-II. Sceduled for elective cystoscopic procedures under spinal anesthesia.
排除标准
- •Patient refusal. Contraindication to spinal anesthesia(e.g coagulopathy ,infection at injection site).
- •Known hypersensitivity to bupivacaine. Significant cardiovascular,hepatic or renal disease.
研究组 & 干预措施
0.5% hyperbaric bupivacaine group
Patients will receive spinal anesthesia with 0.5% hyperbaric bupivacainefor cystoscopic procedures.hemodynamic parameters will be monitored and compared with other group.
干预措施: 0.5% Hyperbaric Bupivicaine (Drug)
0.75% hyperbaric bupivacaine group
Patients will receive spinal anesthesia with 0.75% hyperbaric bupivacaine for cystoscopic procedures.hemodynamic stability and related outcomes will be assesed and compared with 0.5% group.
干预措施: 0.75% hyperbaric bupivacaine (Drug)
结局指标
主要结局
Measurement of frequency and mean changes in systolic blood pressure and heart rate
时间窗: From institution of spinal block upto 30 minutes
Measurement of frequency and mean changes in systolic blood pressure(to assess hypotension) and heart rate(to assess bradycardia)will be recorded and analyzed to evaluate the hemodynamic effects of 0.5% vs 0.75% hyperbaric bupivacaine in patients undergoing cystoscopic procedures under spinal anesthesia.
次要结局
- Requirement for Vasopressors, Atropine ,and Intravenous fluids(From institution of spinal block upto 30 minutes)
研究者
Salbia Bibi
Postgraduate Trainee
PAEC General Hospital, Islamabad