Comparison of the Effects of TIVA vs VIMA on Content of GSK-3beta in Leucocytes in On-pump Patients

August 13, 2019 updated by: Valery V. Likhvantsev, Professor, Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy

Comparison of the Effects of TIVA vs VIMA on Content of GSK-3beta in Leucocytes in On-pump Patients: a Randomized Clinical Trial

Assessment of GSK-3beta contents in leukocytes in on-pump cardiosurgical patients receiving either volatile or intravenous anesthesia

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 129110
        • Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy

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 to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

elective on-pump CABG

Exclusion Criteria:

re-operation

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

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: VIMA
Patiens receiving volatile induction and maitenance of anesthesia
Drug: Sevoflurane
ACTIVE_COMPARATOR: TIVA
Patiens receiving total intravenous anesthesia based on propofol
Drug: Propofol
ACTIVE_COMPARATOR: Combi
Patiens receiving total intravenous induction and volatile anesthesia
Drug: Propofol
Drug: Sevoflurane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Gsk-3beta base line content
Time Frame: base line
base line
Gsk-3beta content after induction
Time Frame: 20 minutes after tracheal intubation
20 minutes after tracheal intubation
Gsk-3beta content after surgery
Time Frame: immediately after surgery
immediately after surgery

Collaborators and Investigators

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

Sponsor

Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy

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

February 1, 2016

Primary Completion (ACTUAL)

December 1, 2018

Study Completion (ACTUAL)

December 1, 2018

Study Registration Dates

First Submitted

February 16, 2016

First Submitted That Met QC Criteria

February 16, 2016

First Posted (ESTIMATE)

February 19, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 15, 2019

Last Update Submitted That Met QC Criteria

August 13, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GSK-TV-L

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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