NCT02783443

Effect General and Regional Anesthesia on Glycocalyx

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: University Hospital Hradec Kralove · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anesthesia
• Glycocalyx
• Perfused Boundary Region

Interventions

Type	Name	Description
OTHER	General anesthesia	General anesthesia
OTHER	Regional anesthesia	Regional anesthesia

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2016-05-26
• Last updated: 2019-11-27
• Results posted: 2019-11-27