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NCT02783443 Clinical Trial

Effect General and Regional Anesthesia on Glycocalyx

Anesthesia Clinical Trial

Official title:
Effect General and Regional Anesthesia on Glycocalyx

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02783443
Other study ID # AZVCR 9307_2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2016
Est. completion date October 2017

Study information
Verified date November 2019
Source University Hospital Hradec Kralove
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Observational study evaluating effect general or regional anaesthesia on glycocalyx by using perfused Boundary Region in sublingual microcirculation.

Description:

Study II: Effect general and regional anaesthesia on GCX Hypothesis to be tested: Regional anaesthesia affects GCX less than general anaesthesia.

The aim of the study: Comparison of two anaesthesia techniques with respect to GCX.

Type of the study: Observational. Subjects: Adult patients ASA 2-3 undergoing elective total knee replacement surgery under general or regional anaesthesia. Sample size calculation (based on expected difference in PRB, alpha error I = 0,05 and study power = 0,99) = 52 patients. Investigators plan to enroll of 60 consecutive patients to reach 30 patients with each type of anaesthesia. Intervention: none. Data to be recorded and analysed: Demographics, ASA, physiologic functions (during surgery and 24 hours after surgery), fluids given, sublingual microcirculation by SDF imaging will be recorded at time points: before anaesthesia, 24 hours after anaesthesia, clinical outcome indicators, microcirculatory data and Perfused Boundary Region.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date October 2017
Est. primary completion date October 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

Adult patients ASA 2-3 undergoing elective total knee replacement surgery

Exclusion Criteria:

None

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• General anesthesia
General anesthesia
• Regional anesthesia
Regional anesthesia

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Hradec Kralove

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Perfused Boundary Region (PBR) PBR is an indirect measure of glycocalyx thickness Change from baseline PBR at 24 hours after surgery
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