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临床试验/CTRI/2025/02/080064
CTRI/2025/02/080064尚未招募不适用

A Study to Compare the Hemodynamic Changes in Patients Undergoing Lower Limb orthopaedic Surgeries under Spinal Anaesthesia When PreLoaded with Crystalloid vs Colloid.

Smt Bhikiben Kanjibhai Shah Medical Institute and Research Cen1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年2月18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
40
试验地点
1
主要终点
his study will help us to know that which out of two intravenous solutions (1) Colloid or (2)Crystalloid is a better preloading solution to achieve the stable hemodynamics during lower limb orthopaedic surgeries.

研究概览

简要总结

A Study to Compare the Hemodynamic Changes in Patients Undergoing Lower Limb orthopaedic Surgeries under Spinal Anaesthesia When PreLoaded with Crystalloid vs Colloid.

 OBJECTIVES To compare the efficacy of ringer lactate vs. HES (Hydroxyethyl Starch) as pre-loading agents in

terms of hemodynamic response to spinal anaesthesia.To compare complications or side effects if any of both the fluids used for pre-loading.

 Inclusion Criteria:

The patients belonging to ASA I and ASA II.

Age Group from 18 to 35 years.

Patients undergoing Lower Limb orthopaedic.

Duration of surgery from 3 to 3.5 hours

 Exclusion Criteria:

All contraindications for spinal anaesthesia like

Patients refusal

Local infections

Spinal deformities

Bleeding disorder

Increased intracranial tension

Systolic blood pressure less than 100mmHg.

Age less than 18 years or more than 60 years.

Concomitant diseases like diabetes mellitus, hypertension, heart diseases, obesity.

Patients other than ASA I and ASA II.

 **Study Site:**Dhiraj Hospital, S.B.K.S M.I.R.C. Piparia, Waghodia, Vadodara, Gujarat.

Study Design: Randomized, Prospective, Observational Study

 Group A  20 patients receiving Inj. RL intravenously at the rate of 10ml per kg.

Group B  20  patients receiving Inj. Hydroxyethyl Starch intravenously at the rate of 10ml per kg.

 Heart rate Systolic and diastolic blood pressure and mean arterial pressure will be monitored every 2 minutes

for the first 10 minutes and then every 5 minutes till the next hour and then every 15 minutes till the end of

surgery

 STATASTICAL ANALYSIS:

We will find mean and standard deviation of all quantitative data and we will use parametric test like student T

test (paired or unpaired), ANOV A (one way or repeated measure) to find statistical mean difference between

variables. P value  less than 0.05 will be considered as significance level.

Percentage will be used for qualitative data and non-parametric tests like chi square, Wilcoxon Rank test,

Friedman test will be used to find significance level between variables and p value less than 0.05 will be considered as

significance level

 LIKELY OUTCOMES/ BENEFITS OF STUDY

This study will help us to know that which out of two intravenous solutions  Colloid or Crystalloid is a better

preloading solution to achieve the stable hemodynamics lower limb orthopaedic surgeries.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
All

入选标准

  • The patients belonging to ASA-I and ASA-II.
  • Age Group from 18 to 35 years.
  • Patients undergoing LSCS.
  • Duration of surgery from 3 to 3.5 hours.

排除标准

  • A)All contraindications for spinal anaesthesia like: Patients refusal Local infections Spinal deformities Bleeding disorders Increased intracranial tension Systolic blood pressure less than 100mmHg. B)Age less than 18 years or more than 60 years.
  • C)Concomitant diseases – diabetes mellitus, hypertension, heart diseases, obesity.
  • D)Patients other than ASA-I and ASA-II.

结局指标

主要结局

his study will help us to know that which out of two intravenous solutions (1) Colloid or (2)Crystalloid is a better preloading solution to achieve the stable hemodynamics during lower limb orthopaedic surgeries.

时间窗: Heart rate Systolic and diastolic blood pressure and mean arterial pressure will be monitored every 2 minutes for the first 10 minutes and then every 5 minutes till the next hour and then every 15 minutes till the end of surgery

次要结局

  • Requirement of vasopressor.Incidence of nausea and vomiting.Incidence if allergic reactions

研究者

发起方
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Cen
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Vishwa Shah

Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre

研究点 (1)

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