The Effect of Anesthetics Agents on Vascular Injury and Level of Syndecan-1 During Knee Surgery

February 27, 2020 updated by: Seong-Hyop Kim, Konkuk University Medical Center

Ischeic reperfusion injury lead to a cellular dyfunction and increase in soluble glycocalyx of blood flow. syndecan-1 was a marker of glycocalyx.

The purpose of this study is to prove the variation of level of serum syndecan-1 between preoperative and postoperative period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The patients were allocated randomly to receive propofol or desflurane. Also, a total of 6ml of blood sample was obtained for total 6 times in consecutive order.

  1. Preoperation (immediate before anesthesia induction)
  2. Immediate before tourniquet off
  3. 5 min after tourniquet off
  4. PACU
  5. postoperative 6 hours
  6. postoperative 24 hours

Serum in blood will be obtained and level of serum cytokine will be evaluated by enzyme-linked immunosorbent assay

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

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

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients who was planned to undergo knee surgery.

Exclusion Criteria:

  • age < 20 years old
  • history of previous cancer
  • history of previous peripheral vascular disease
  • Emergency surgery

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: propofol group
The patient who anesthetized by using propofol.
Drug: propofol group
Patient will be anesthetized by using propofol infusion during operation.
Other Names:
  • Propofol
Active Comparator: Desflurane group
The patient who anesthetized by using sevoflurane.
Drug: Desflurane group
Patient will be anesthetized by using desflurane inhalation during operation.
Other Names:
  • Desflurane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Syndecan-1
Time Frame: Preoperative time, Immediate before tourniquet off,5 min after tourniquet off,PACU, postoperation after 6hours, postoperation after 24hours
change of level of syndecan-1 (scores range from 0 to 100)
Preoperative time, Immediate before tourniquet off,5 min after tourniquet off,PACU, postoperation after 6hours, postoperation after 24hours

Collaborators and Investigators

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

Sponsor

Konkuk University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

May 30, 2016

Primary Completion (Actual)

March 26, 2018

Study Completion (Actual)

February 27, 2020

Study Registration Dates

First Submitted

April 28, 2016

First Submitted That Met QC Criteria

April 28, 2016

First Posted (Estimate)

April 29, 2016

Study Record Updates

Last Update Posted (Actual)

February 28, 2020

Last Update Submitted That Met QC Criteria

February 27, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUH1160100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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