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

Primary Purpose

Ischemia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
propofol group
Desflurane group
Sponsored by
Konkuk University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Ischemia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Konkuk University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

propofol group

Desflurane group

Arm Description

The patient who anesthetized by using propofol.

The patient who anesthetized by using sevoflurane.

Outcomes

Primary Outcome Measures

Syndecan-1
change of level of syndecan-1 (scores range from 0 to 100)

Secondary Outcome Measures

Full Information

First Posted
April 28, 2016
Last Updated
February 27, 2020
Sponsor
Konkuk University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02756715
Brief Title
The Effect of Anesthetics Agents on Vascular Injury and Level of Syndecan-1 During Knee Surgery
Official Title
The Effect of Anesthetics Agents on Vascular Injury and Level of Syndecan-1 During Knee Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
May 30, 2016 (Actual)
Primary Completion Date
March 26, 2018 (Actual)
Study Completion Date
February 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konkuk University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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. Preoperation (immediate before anesthesia induction) Immediate before tourniquet off 5 min after tourniquet off PACU postoperative 6 hours postoperative 24 hours Serum in blood will be obtained and level of serum cytokine will be evaluated by enzyme-linked immunosorbent assay

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
propofol group
Arm Type
Active Comparator
Arm Description
The patient who anesthetized by using propofol.
Arm Title
Desflurane group
Arm Type
Active Comparator
Arm Description
The patient who anesthetized by using sevoflurane.
Intervention Type
Drug
Intervention Name(s)
propofol group
Other Intervention Name(s)
Propofol
Intervention Description
Patient will be anesthetized by using propofol infusion during operation.
Intervention Type
Drug
Intervention Name(s)
Desflurane group
Other Intervention Name(s)
Desflurane
Intervention Description
Patient will be anesthetized by using desflurane inhalation during operation.
Primary Outcome Measure Information:
Title
Syndecan-1
Description
change of level of syndecan-1 (scores range from 0 to 100)
Time Frame
Preoperative time, Immediate before tourniquet off,5 min after tourniquet off,PACU, postoperation after 6hours, postoperation after 24hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seong-Hyop Kim, M.D,Ph.D
Organizational Affiliation
Konkuk University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
143-729
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33564684
Citation
Oh CS, Choi JM, Park EH, Piao L, Park HJ, Rhee KY, Kim SH. Impact of Anesthetic Agents on Endothelial Glycocalyx Injury during Total Knee Arthroplasty: Desflurane- vs. Propofol-Based Anesthesia-A Prospective Randomized Controlled Trial. Biomed Res Int. 2021 Jan 23;2021:8880267. doi: 10.1155/2021/8880267. eCollection 2021.
Results Reference
derived

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

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