Effect General and Regional Anesthesia on Glycocalyx

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

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Key information

Conditions

Anesthesia Glycocalyx Perfused Boundary Region

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

None

Treatment and study plan

General anesthesia

Other

General anesthesia

Regional anesthesia

Other

Regional anesthesia

Primary outcomes

Change in Perfused Boundary Region (PBR)

Time frame: Change from baseline PBR at 24 hours after surgery

PBR is an indirect measure of glycocalyx thickness

Sponsors and collaborators

Lead sponsor

University Hospital Hradec Kralove

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: May 26, 2016
Registry last updated: Nov 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed