Back to resultsThe Effect of Remote Ischemic Preconditioning on Postoperative Cognitive Dysfunction in Total Knee Replacement
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Remote ischemic preconditioning
Sponsored by
About this trial
This is an interventional prevention trial for Knee Osteoarthritis
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
Sites / Locations
- Konkuk University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
C group
R group
Arm Description
Remote ischemic preconditioning will not be applied
Remote ischemic preconditioning will be applied.
Outcomes
Primary Outcome Measures
Incidence of cerebral desaturation
cerebral saturation will be assessed by using near infrared spectroscopy
Secondary Outcome Measures
Incidence of postoperative delirium
postoperative delirium will be assessed by using CAM method.
Full Information
NCT ID
NCT02478216
First Posted
April 20, 2015
Last Updated
June 18, 2018
Sponsor
Konkuk University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02478216
Brief Title
The Effect of Remote Ischemic Preconditioning on Postoperative Cognitive Dysfunction in Total Knee Replacement
Official Title
The Effect of Remote Ischemic Preconditioning on Postoperative Cognitive Dysfunction in Total Knee Replacement
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konkuk University Medical Center
4. Oversight
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
C group
Arm Type
No Intervention
Arm Description
Remote ischemic preconditioning will not be applied
Arm Title
R group
Arm Type
Experimental
Arm Description
Remote ischemic preconditioning will be applied.
Intervention Type
Procedure
Intervention Name(s)
Remote ischemic preconditioning
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of cerebral desaturation
Description
cerebral saturation will be assessed by using near infrared spectroscopy
Time Frame
during operation time (an expected average of 2 hours)
Secondary Outcome Measure Information:
Title
Incidence of postoperative delirium
Description
postoperative delirium will be assessed by using CAM method.
Time Frame
up to postoperative 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seong-Hyop Kim, M.D,Ph.D
Organizational Affiliation
Konkuk University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
143-729
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Effect of Remote Ischemic Preconditioning on Postoperative Cognitive Dysfunction in Total Knee Replacement
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