1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   Response -  Analytic Code
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - For individual participant data meta-analysis.
   


5. By what mechanism will data be made available?
   Response (Others) -  drpriya0809@gmail.com


6. For how long will this data be available start date provided 18-12-2025 and end date provided 19-12-2028?
   Response - Beginning 9 months and ending 36 months following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - nil

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.