Effects of Limb Remote Ischemic Preconditioning for Prevention of Delirium in Elderly Patients After Non-cardiac Surgery
LRIP-D
1 other identifier
interventional
611
0 countries
N/A
Brief Summary
To investigate whether limb remote ischemic preconditioning (LRIP) could safely decrease the incidence of delirium in elderly patients after non-cardiac surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2017
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2017
CompletedFirst Posted
Study publicly available on registry
January 23, 2017
CompletedStudy Start
First participant enrolled
February 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedJanuary 23, 2017
January 1, 2017
Same day
January 19, 2017
January 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the incidence of delirium
in the first 7 days after surgery
Study Arms (2)
Limb RIPC
EXPERIMENTALThe limb RIPC protocol was applied after anesthetic induction and before the start of surgery. The limb RIPC was induced by placing a blood pressure cuff on the left upper arm of patient for three inflating-deflating cycles: 5 min inflating to 200 mmHg followed by a 5 min reperfusion with deflating the cuff.
Convention
NO INTERVENTIONElderly patients undergoing non-cardiac surgery received no treatment after induction of anaesthesia
Interventions
LRIP consisted of three cycles of left upper limb ischemia induced by inflating a blood pressure cuff on the left upper arm to 200mmHg, with an intervening 5 minutes of reperfusion, during which time the cuff was deflated.
Eligibility Criteria
You may qualify if:
- elderly patients received elective non-cardiac surgery with general anesthesia
- anticipated surgery time \> 2 hours
You may not qualify if:
- age \< 65 years old
- Acute coronary syndrome or myocardial infraction within 3 months
- Chronic obstructive pulmonary emphysema
- Serious hepatic dysfunction (Child-Pugh class C)
- serious renal dysfunction (undergoing dialysis before surgery)
- Ejection fraction less than 40%
- Poor pulmonary function (PaO2 \<60mmHg)
- Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis
- Inability to communicate in the preoperative period (coma, profound dementia, or language barrier)
- Brain injury or neurosurgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ke-Xuan Liu, Ph.D
Nanfang Hospital, the Southern Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Anesthesiology, Nanfang Hospital, Southern Medical University, Guangzhou, China
Study Record Dates
First Submitted
January 19, 2017
First Posted
January 23, 2017
Study Start
February 1, 2017
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
January 23, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share