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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-28

Study Completion Date

2018-08-30

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.

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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.

Conditions

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Spinal Anaesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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normal saline

Patients will receive normal saline 0.9% 15 ml/kg over 15-20 minutes.

Group Type ACTIVE_COMPARATOR

Normal saline

Intervention Type PROCEDURE

normal saline 0.9% 15 ml/kg over 15-20 minutes.

Hydroxyethyl starch

Patients will receive hydroxyethyl starch 130/0.4 in 0.9 % sodium chloride 5 ml/kg over 15-20 minutes.

Group Type ACTIVE_COMPARATOR

hydroxyethyl starch

Intervention Type PROCEDURE

hydroxyethyl starch 130/0.4 in 0.9 % sodium chloride 5 ml/kg over 15-20 minutes.

Hypertonic saline

Patients will receive hypertonic saline 3% (7ml/kg) over 15-20 minutes.

Group Type ACTIVE_COMPARATOR

Hypertonic saline

Intervention Type PROCEDURE

hypertonic saline 3% (7ml/kg) over 15-20 minutes.

Interventions

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Normal saline

normal saline 0.9% 15 ml/kg over 15-20 minutes.

Intervention Type PROCEDURE

hydroxyethyl starch

hydroxyethyl starch 130/0.4 in 0.9 % sodium chloride 5 ml/kg over 15-20 minutes.

Intervention Type PROCEDURE

Hypertonic saline

hypertonic saline 3% (7ml/kg) over 15-20 minutes.

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No