The Effect of Remote Ischemic Preconditioning on Postoperative Cognitive Dysfunction in Total Knee Replacement
1 other identifier
interventional
72
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable knee-osteoarthritis
Started Feb 2015
1 active site
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
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 20, 2015
CompletedFirst Posted
Study publicly available on registry
June 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedJune 20, 2018
June 1, 2018
1.2 years
April 20, 2015
June 18, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of cerebral desaturation
cerebral saturation will be assessed by using near infrared spectroscopy
during operation time (an expected average of 2 hours)
Secondary Outcomes (1)
Incidence of postoperative delirium
up to postoperative 7 days
Study Arms (2)
C group
NO INTERVENTIONRemote ischemic preconditioning will not be applied
R group
EXPERIMENTALRemote ischemic preconditioning will be applied.
Interventions
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.
Eligibility Criteria
You may qualify if:
- patient who was planned to undergo total knee replacement surgery
You may not qualify if:
- emergency operation
- underlying cerebrovascular disease
- underlying peripheral vascular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Konkuk University Medical Center
Seoul, 143-729, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seong-Hyop Kim, M.D,Ph.D
Konkuk University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 20, 2015
First Posted
June 23, 2015
Study Start
February 1, 2015
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
June 20, 2018
Record last verified: 2018-06