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The Effect of Remote Ischemic Preconditioning on Postoperative Cognitive Dysfunction in Total Knee Replacement

The Effect of Remote Ischemic Preconditioning on Postoperative Cognitive Dysfunction in Total Knee Replacement

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02478216
Enrollment
72
Registered
2015-06-23
Start date
2015-02-28
Completion date
2016-05-31
Last updated
2018-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Brief summary

The patients were allocated randomly to receive remote preconditioning group (RIPC group, R) or not (Control group, C) using sealed envelopes with the options inside the sealed envelope of R and C before anaesthesia induction. The registered nurse who did not participate in patient care and was blind to the study performed the all randomization process. All medical staffs who involved the patient care were blind to the study. All data were collected by trained observers who were blind to the study and did not participate in patient care

Detailed description

RIPC was performed just after anesthesia induction and before the tourniquet application for the operation site. The tourniquet was applied at the opposite site of thigh in the both groups. The thigh was covered with blanket to conceal the tourniquet inflation and deflation. For R group, 3 cycles of tourniquet inflation for 5 minutes with 2 × systemic systolic arterial blood pressure of arrival at operation room and deflation were performed. For C group, the tourniquet was applied with same manner for R group except inflation pressure of 0 mmHg. The tourniquet pressure according to the randomization was set by the registered nurse who participated in the patients' allocation. The monitor of tourniquet pressure was sealed for blindness.

Interventions

PROCEDURERemote ischemic preconditioning

The tourniquet was applied at the opposite site from operation thigh in the both groups. The thigh was covered with blanket to conceal the tourniquet inflation and deflation. A total of 3 cycles of tourniquet inflation for 5 minutes with 2 × systemic systolic arterial blood pressure of arrival at operation room and deflation were performed.

Sponsors

Konkuk University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patient who was planned to undergo total knee replacement surgery

Exclusion criteria

* emergency operation * underlying cerebrovascular disease * underlying peripheral vascular disease

Design outcomes

Primary

MeasureTime frameDescription
Incidence of cerebral desaturationduring operation time (an expected average of 2 hours)cerebral saturation will be assessed by using near infrared spectroscopy

Secondary

MeasureTime frameDescription
Incidence of postoperative deliriumup to postoperative 7 dayspostoperative delirium will be assessed by using CAM method.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026