- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02783443
Effect General and Regional Anesthesia on Glycocalyx
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Adult patients ASA 2-3 undergoing elective total knee replacement surgery
Exclusion Criteria:
None
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
General anesthesia
Adult patients ASA 2-3 undergoing elective total knee replacement surgery under general anaesthesia.
|
General anesthesia
|
Regional anesthesia
Adult patients ASA 2-3 undergoing elective total knee replacement surgery under regional anaesthesia.
|
Regional anesthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Change from baseline PBR at 24 hours after surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Vladimir Cerny, MD, University Hospital Hradec Kralova, Czech Republic
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AZVCR 9307_2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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