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

Sponsor

Konkuk University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02478216

Collaborator

(none)

Enrollment

Location

Arms

14.9

Actual Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Procedure: Remote ischemic preconditioning	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Feb 1, 2015

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: C group Remote ischemic preconditioning will not be applied
Experimental: R group Remote ischemic preconditioning will be applied.	Procedure: 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.

Arm

Intervention/Treatment

No Intervention: C group

Remote ischemic preconditioning will not be applied

Experimental: R group

Remote ischemic preconditioning will be applied.

Procedure: 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.

Outcome Measures

Primary Outcome Measures

Incidence of cerebral desaturation [during operation time (an expected average of 2 hours)]
cerebral saturation will be assessed by using near infrared spectroscopy

Secondary Outcome Measures

Incidence of postoperative delirium [up to postoperative 7 days]
postoperative delirium will be assessed by using CAM method.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patient who was planned to undergo total knee replacement surgery

Exclusion Criteria:

emergency operation
underlying cerebrovascular disease
underlying peripheral vascular disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Konkuk University Medical Center	Seoul		Korea, Republic of	143-729

Sponsors and Collaborators

Konkuk University Medical Center

Investigators

Principal Investigator: Seong-Hyop Kim, M.D,Ph.D, Konkuk University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Seong-Hyop Kim, Professor, Konkuk University Medical Center

ClinicalTrials.gov Identifier:

NCT02478216

Other Study ID Numbers:

KUH1160078

First Posted:

Jun 23, 2015

Last Update Posted:

Jun 20, 2018

Last Verified:

Jun 1, 2018

Additional relevant MeSH terms:

Osteoarthritis, Knee

Postoperative Cognitive Complications

Cognitive Dysfunction

Study Results

No Results Posted as of Jun 20, 2018