Effect General and Regional Anesthesia on Glycocalyx
Conditions: Anesthesia, Glycocalyx, Perfused Boundary Region
Sponsor: University Hospital Hradec Kralove

COVER PAGE 
 
Official title: Effect of general and regional anesthesia on endothelial glykokalyx  
 
NTC number: NCT02783443 
 
Date of the document: 7. 11. 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Objective: The aim of the observational study was to evaluate the changes of PBR in patients 
undergoing elective joint surgery under general (GA) vs. neuraxial anesthesia (NA). Our 
hypothesis was that PBR will be lower in patients in NA. 
Hypothesis to be tested: Regional anaesthesia affects GCX less than general anaesthesia. 
Design: Two center prospective observational study. 
Methods: Sixty consecutive patients (ASA 1-3) undergoing elective total knee or hip 
replacement under GA or NA were included in this prospective observational cohort study. 
PBR in the sublingual microcirculation was recorded in each patient using SDF at two time 
points - before surgery and 2 hours after surgery. 
Scientific background: Damage of the endothelial glycocalyx (EG) has been described during 
surgery, but the effect of different anesthesia techniques remains unknown. Perfused 
boundary region (PBR) evaluated by side-stream dark field (SDF) imaging of the sublingual 
microcirculation enables in vivo EG assessment. PBR values are inversely related to the EG 
thickness.  
Statistical considerations: Based on the expected difference in PBR between patients under 
GA and NA, the alpha error I = 0.05 and study power = 0.99, sample size calculation was 52 
patients. We aimed to enrol 60 consecutive patients to reach 30 patients with each type of 
anesthesia, either general anesthesia or neuraxial.  
For statistical analysis, we used Graph Pad Prism v6.0c (GraphPad Software, Inc., CA, USA). 
All data were tested for normality prior testing by D’Agostino-Pearson omnibus normality 
test. Data are expressed as mean (and standard deviation) or median (and interquartile range), 
a value of p ≤ 0.05 was considered as statistically significant for paired and unpaired t-tests. 
Z-test we used for two populations proportion analysis. 
 
 
 
 
 
Chief Investigator: Vladimir Cerny  
Sponsor Number: AZVCR 15-3881/A, all rights reserved. 
Name of site: Hradec Kralove