NCT05082207

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

October 16, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2022

Completed
Last Updated

August 17, 2022

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

September 26, 2021

Last Update Submit

August 15, 2022

Conditions

Tourniquets

Keywords

thiol/disulfide homeostasisischemic preconditioning

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Remote Ischaemic preconditioning (RIPC)

EXPERIMENTAL

The group underwent Remote Ischemic Preconditioning.

Other: Remote Ischemic Preconditioning

Sham Group

SHAM COMPARATOR

Sham control group without remote ischemic preconditioning

Other: sham group

Interventions

Remote Ischemic PreconditioningOTHER

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.

Also known as: RIPC group
Remote Ischaemic preconditioning (RIPC)
sham groupOTHER

a deflated cuff placed on the upper arm for 30 min

Sham Group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Betul Kozanhan

Konya, 42005, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass.Prof.

Study Record Dates

First Submitted

September 26, 2021

First Posted

October 18, 2021

Study Start

October 16, 2021

Primary Completion

April 17, 2022

Study Completion

May 15, 2022

Last Updated

August 17, 2022

Record last verified: 2022-08

Locations

TU(1)