Effect General and Regional Anesthesia on Glycocalyx

November 8, 2019 updated by: Vladimir Cerny, University Hospital Hradec Kralove
Observational study evaluating effect general or regional anaesthesia on glycocalyx by using perfused Boundary Region in sublingual microcirculation.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

60

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Other: General anesthesia
General anesthesia
Regional anesthesia
Adult patients ASA 2-3 undergoing elective total knee replacement surgery under regional anaesthesia.
Other: Regional anesthesia
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

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Hradec Kralove

Investigators

  • Principal Investigator: Vladimir Cerny, MD, University Hospital Hradec Kralova, Czech Republic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

May 20, 2016

First Submitted That Met QC Criteria

May 23, 2016

First Posted (Estimate)

May 26, 2016

Study Record Updates

Last Update Posted (Actual)

November 27, 2019

Last Update Submitted That Met QC Criteria

November 8, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AZVCR 9307_2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

On request if privacy guaranteed

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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