Ischemic Preconditioning and Thiol-disulfide Balance

Tourniquets Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05082207
• Other study ID #: ischemic preconditioning TDH
• Status: Completed
• Phase: N/A
• Start date: October 16, 2021
• Est. completion date: May 15, 2022

Study information

• Verified date: August 2022
• Source: Konya Meram State Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 15, 2022
• Est. primary completion date: April 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ischemia
• Tourniquets

Intervention

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.
• sham group
a deflated cuff placed on the upper arm for 30 min

Locations

Country	Name	City	State
Turkey	Betul Kozanhan	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Konya Meram State Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24th hour after surgery