Effect General and Regional Anesthesia on Glycocalyx

Completed

• Conditions: Glycocalyx; Perfused Boundary Region; Anesthesia
• Interventions: Other: Regional anesthesia; Other: General anesthesia

• Registration Number: NCT02783443
• Lead Sponsor: University Hospital Hradec Kralove

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2016-05-20
• Study First Submitted QC: 2016-05-23
• Study First Posted: 2016-05-26
• Study Start: 2016-06
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Results First Submitted: 2019-03-25
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-08
• Last Update Submitted: 2019-11-08
• Results First Posted: 2019-11-27
• Last Update Posted: 2019-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Regional anesthesia	Regional anesthesia	Adult patients ASA 2-3 undergoing elective total knee replacement surgery under regional anaesthesia.
General anesthesia	General anesthesia	Adult patients ASA 2-3 undergoing elective total knee replacement surgery under general anaesthesia.

Primary Outcome Measures

Name	Time	Method
Change in Perfused Boundary Region (PBR)	Change from baseline PBR at 24 hours after surgery	PBR is an indirect measure of glycocalyx thickness