Clinical Trials Directory

Trials / Completed

CompletedNCT03681847

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
120 (actual)
Sponsor
National Cancer Institute, Egypt · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

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

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

Interventions

TypeNameDescription
PROCEDURENormal salinenormal saline 0.9% 15 ml/kg over 15-20 minutes.
PROCEDUREhydroxyethyl starchhydroxyethyl starch 130/0.4 in 0.9 % sodium chloride 5 ml/kg over 15-20 minutes.
PROCEDUREHypertonic salinehypertonic saline 3% (7ml/kg) over 15-20 minutes.

Timeline

Start date
2018-02-28
Primary completion
2018-08-30
Completion
2018-08-30
First posted
2018-09-24
Last updated
2018-09-24

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT03681847. Inclusion in this directory is not an endorsement.