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临床试验/CTRI/2025/09/095453
CTRI/2025/09/095453尚未招募不适用

: Comparative evaluation of incidence of hypotension in unilateral versus bilateral spinal anaesthesia in patients undergoing percutaneous nephrolithotomy.

Manisha Yadav1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年10月8日最近更新:

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

发起方
Manisha Yadav
申办方类型
Other [Dr Manisha Yadav]
责任方
Principal Investigator
主要研究者

Manisha Yadav

ESIC Medical College and Hos[pital ,Faridabad

研究点 (1)

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