: Comparative evaluation of incidence of hypotension in unilateral versus bilateral spinal anaesthesia in patients undergoing percutaneous nephrolithotomy.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To evaluate and compare the incidence of hypotension following unilateral spinal and bilateral spinal anaesthesia in patients undergoing percutaneous nephrolithotomy.
研究概览
简要总结
**Study Title:**Comparative evaluation of efficacy of unilateral versus bilateral spinal anaesthesia in patients undergoing percutaneous nephrolithotomy.
Study Design:
- Type Randomized controlled trial
- Location ESIC Medical College and Hospital, Faridabad, Haryana
- Duration October 2025 to March 2027
Participants:
-
Inclusion
-
Adults aged 18–60 years
-
ASA physical status I or II
-
Scheduled for elective percutaneous nephrolithotomy
-
Exclusion
-
Contraindications to spinal anaesthesia (e.g., coagulation disorders, infection, allergy, increased intracranial pressure)
-
Pregnant/lactating females
-
BMI > 30 kg/m²
-
Expected surgery duration > 2 hours
Sample Size
- Total of 80 patients
Group Allocation
- Group U Unilateral spinal anaesthesia (n=40)
- Group BBilateral spinal anaesthesia (n=40)
Objectives
-
Primary Objective
-
Compare incidence of hypotension between the two groups
-
Secondary Objectives
-
Incidence of bradycardia
-
Spinal block characteristics:
-
Sensory onset, level, duration
-
Motor onset, level, duration
-
Total dose of mephentermine required
-
Duration of anaesthesia
Assessment & Analysis
- Data will be compiled and analyzed statistically to evaluate outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Adult patients of Age 18-60 years with American Society of Anaesthesiologist physical status I and II of either sex posted for elective percutaneous nephrolithotomy.
排除标准
- 未提供
结局指标
主要结局
To evaluate and compare the incidence of hypotension following unilateral spinal and bilateral spinal anaesthesia in patients undergoing percutaneous nephrolithotomy.
时间窗: Baseline | 2 min | 4 min | 6 min | 8 min | 10 min | 12 min | 14 min | 16 min | 18 min | 20 min | 25 min | 30 min | 35 min | 40 min | 45 min | 50 min | 55 min | 60 min
次要结局
- To evaluate and compare in both groups(• the incidence of bradycardia)
研究者
Manisha Yadav
ESIC Medical College and Hos[pital ,Faridabad
