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

NCT ID: NCT02478216

Last Updated: 2018-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-05-31

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

C group

Remote ischemic preconditioning will not be applied

Group Type: NO_INTERVENTION

No interventions assigned to this group

R group

Remote ischemic preconditioning will be applied.

Group Type: EXPERIMENTAL

Remote ischemic preconditioning

Intervention Type: PROCEDURE

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.

Interventions

Remote 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• patient who was planned to undergo total knee replacement surgery

Exclusion Criteria

• emergency operation
• underlying cerebrovascular disease
• underlying peripheral vascular disease

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Konkuk University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Seong-Hyop Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seong-Hyop Kim, M.D,Ph.D

Role: PRINCIPAL_INVESTIGATOR

Konkuk University Medical Center

Locations

Konkuk University Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

KUH1160078

Identifier Type: -

Identifier Source: org_study_id