Crystalloids Versus Colloids Versus Hypertonic Saline as a Co-load During Spinal Anesthesia.

Study Overview
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Brief Summary
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Spinal anesthesia is commonly accompanied by hypotension due to vasodilation that follows sympathetic blockade and decreased systemic vascular resistance. Prevention of hypotension is usually achieved through administration of fluids and vasopressors .There is an ongoing debate concerning both the proper fluid timing, pre-load against co-load and fluid type crystalloids against colloids .This study aims at comparing the effectiveness of co-loading of crystalloids versus colloids versus hypertonic saline 3% in preventing hypotension induced by spinal anesthesia.

Detailed Description
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Spinal anesthesia is commonly accompanied by hypotension due to vasodilation that follows sympathetic blockade and decreased systemic vascular resistance. Prevention of hypotension is usually achieved through administration of fluids and vasopressors . Fluids are either administrated before initiation of spinal anesthesia which is defined as fluid pre-loading or at time of initiation of spinal anesthesia which is defined as fluid co-loading .There is an ongoing debate concerning both the proper fluid timing, pre-load against co-load and fluid type crystalloids against colloids. Fluid preloading with colloids appears to have superior effect on that of crystalloids as the later shows a shorter intravascular half-life. While both colloid and crystalloid co-loading show comparable results .Although crystalloid preloading has been the traditional regimen for long time, it failed to reduce the incidence of hypotension. This is because crystalloids rapidly distribute out of the intravascular compartment to the interstitial space. Superiority of fluid co-loading might be explained by decrease of the extravascular crystalloid redistribution secondary to the simultaneous vasodilatation response to sympathetic block.This study aims at comparing the effectiveness of co-loading of crystalloids versus colloids versus hypertonic saline 3% in preventing hypotension induced by spinal anesthesia.

Official Title
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Crystalloids Versus Colloids Versus Hypertonic Saline Co-load During Spinal Anesthesia: Which is More Effective

Conditions
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Spinal Anaesthesia

Intervention / Treatment
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* Procedure: Normal saline
* Procedure: hydroxyethyl starch
* Procedure: Hypertonic saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-65 years ASA II-III Elective lower abdominal surgeries Exclusion Criteria: Coagulation defects Abnormal kidney or liver functions Local infection at site of injection Uncontrolled hypertension Bone metastases Cardiac disease Elevated serum sodium level > 145 mEq/L

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: normal saline<br>Patients will receive normal saline 0.9% 15 ml/kg over 15-20 minutes. | Procedure: Normal saline<br>* normal saline 0.9% 15 ml/kg over 15-20 minutes.<br>|
| Active Comparator: Hydroxyethyl starch<br>Patients will receive hydroxyethyl starch 130/0.4 in 0.9 % sodium chloride 5 ml/kg over 15-20 minutes. | Procedure: hydroxyethyl starch<br>* hydroxyethyl starch 130/0.4 in 0.9 % sodium chloride 5 ml/kg over 15-20 minutes.<br>|
| Active Comparator: Hypertonic saline<br>Patients will receive hypertonic saline 3% (7ml/kg) over 15-20 minutes. | Procedure: Hypertonic saline<br>* hypertonic saline 3% (7ml/kg) over 15-20 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypotension | The development of hypotension | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum sodium level | measurement of serum sodium level | 3 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertonic saline, colloids, normal saline