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Ischemic Preconditioning and Thiol-disulfide Balance

Primary Purpose

Tourniquets

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Remote Ischemic Preconditioning
sham group
Sponsored by
Konya Meram State Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tourniquets focused on measuring thiol/disulfide homeostasis, ischemic preconditioning

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • ASA I-III patients who will undergo total knee arthroplasty surgery under elective conditions

Exclusion Criteria:

  • emergency operation,
  • Underlying neurological disorder,
  • Underlying peripheral vascular disease,
  • other types of concurrent surgery.

Sites / Locations

  • Betul Kozanhan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Remote Ischaemic preconditioning (RIPC)

Sham Group

Arm Description

The group underwent Remote Ischemic Preconditioning.

Sham control group without remote ischemic preconditioning

Outcomes

Primary Outcome Measures

thiol/disulfide homeostasis
Thiol/disulphide homeostasis will be determined at preoperatively and just before the tourniquet opened and at the 1st, 6th and 24th hours after the tourniquet is opened.

Secondary Outcome Measures

Full Information

First Posted
September 26, 2021
Last Updated
August 15, 2022
Sponsor
Konya Meram State Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05082207
Brief Title
Ischemic Preconditioning and Thiol-disulfide Balance
Official Title
Effect of Ischemic Preconditioning on Dynamic Thiol-disulfide Balance, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 16, 2021 (Actual)
Primary Completion Date
April 17, 2022 (Actual)
Study Completion Date
May 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konya Meram State Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Various strategies have been proposed to prevent or mitigate the effects of ischemia-reperfusion injury following the use of tourniquets in orthopedic surgery cases. One of them is applying "remote ischemic preconditioning." This randomized controlled trial is planned to evaluate the effectiveness of remote ischemic preconditioning in preventing tourniquet-induced ischemia-reperfusion injury in total knee arthroscopy with dynamic thiol-disulfide homeostasis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourniquets
Keywords
thiol/disulfide homeostasis, ischemic preconditioning

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remote Ischaemic preconditioning (RIPC)
Arm Type
Experimental
Arm Description
The group underwent Remote Ischemic Preconditioning.
Arm Title
Sham Group
Arm Type
Sham Comparator
Arm Description
Sham control group without remote ischemic preconditioning
Intervention Type
Other
Intervention Name(s)
Remote Ischemic Preconditioning
Other Intervention Name(s)
RIPC group
Intervention Description
Three cycles of 5-min upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to a pressure of systolic blood pressure plus 50 mm Hg.
Intervention Type
Other
Intervention Name(s)
sham group
Intervention Description
a deflated cuff placed on the upper arm for 30 min
Primary Outcome Measure Information:
Title
thiol/disulfide homeostasis
Description
Thiol/disulphide homeostasis will be determined at preoperatively and just before the tourniquet opened and at the 1st, 6th and 24th hours after the tourniquet is opened.
Time Frame
24th hour after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ASA I-III patients who will undergo total knee arthroplasty surgery under elective conditions Exclusion Criteria: emergency operation, Underlying neurological disorder, Underlying peripheral vascular disease, other types of concurrent surgery.
Facility Information:
Facility Name
Betul Kozanhan
City
Konya
ZIP/Postal Code
42005
Country
Turkey

12. IPD Sharing Statement

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Ischemic Preconditioning and Thiol-disulfide Balance

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