Study Results
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View full resultsBasic Information
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COMPLETED
60 participants
OBSERVATIONAL
2016-06-30
2017-10-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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General anesthesia
Adult patients ASA 2-3 undergoing elective total knee replacement surgery under general anaesthesia.
General anesthesia
General anesthesia
Regional anesthesia
Adult patients ASA 2-3 undergoing elective total knee replacement surgery under regional anaesthesia.
Regional anesthesia
Regional anesthesia
Interventions
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General anesthesia
General anesthesia
Regional anesthesia
Regional anesthesia
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University Hospital Hradec Kralove
OTHER
Responsible Party
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Vladimir Cerny
prof. Vladimir Cerny, MD, PhD, FCCM
Principal Investigators
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Vladimir Cerny, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Hradec Kralova, Czech Republic
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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AZVCR 9307_2
Identifier Type: -
Identifier Source: org_study_id
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