Ischemic Preconditioning and Thiol-disulfide Balance

August 15, 2022 updated by: Betul Kozanhan, Konya Meram State Hospital

Effect of Ischemic Preconditioning on Dynamic Thiol-disulfide Balance, Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

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

  • Turkey
      • Konya, Turkey, 42005
        • Betul Kozanhan

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 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Remote Ischaemic preconditioning (RIPC)
The group underwent Remote Ischemic Preconditioning.
Other: Remote Ischemic Preconditioning
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.
Other Names:
  • RIPC group
SHAM_COMPARATOR: Sham Group
Sham control group without remote ischemic preconditioning
Other: sham group
a deflated cuff placed on the upper arm for 30 min

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
thiol/disulfide homeostasis
Time Frame: 24th hour after surgery
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.
24th hour after surgery

Collaborators and Investigators

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

Sponsor

Konya Meram State Hospital

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)

October 16, 2021

Primary Completion (ACTUAL)

April 17, 2022

Study Completion (ACTUAL)

May 15, 2022

Study Registration Dates

First Submitted

September 26, 2021

First Submitted That Met QC Criteria

October 14, 2021

First Posted (ACTUAL)

October 18, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 17, 2022

Last Update Submitted That Met QC Criteria

August 15, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ischemic preconditioning TDH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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