Regional vs General Anesthesia in Patients With Hip Fracture Under Treatment With Clopidogrel
NCT ID: NCT03596060
Last Updated: 2021-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2017-10-20
2022-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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General anesthesia
Hip fracture patients older or equal to 65 years of age, who receive clopidogrel, will be randomly assigned to undertake surgery under general anesthesia in the first 48 hours. Anesthetics to be used are propofol, fentanyl and rocuronium. Maintenance will be achieved with remifentanyl and propofol (TIVA) and the depth of anesthesia will be monitored by BIS. Morphine will be administered bolus IV immediately postoperatively.
Fentanyl
Fentanyl will be used for introduction in both regional and general anesthesia. It will also be used for general anesthesia maintenance.
Propofol
Propofol will be used for introduction in general anesthesia.
Rocuronium
Rocuronium will be used for introduction in general anesthesia.
Morphine
Morphine will be administered bolus iv in General anesthesia group postoperatively before patients leave OR.
Regional anesthesia
Hip fracture patients older or equal to 65 years of age, who receive clopidogrel, will will be randomly assigned undertake surgery under regional anesthesia (spinal) at least 5 days after the discontinuation of clopidogrel. Anesthetics to be used are chirochaine 0.5% and fentanyl.
Fentanyl
Fentanyl will be used for introduction in both regional and general anesthesia. It will also be used for general anesthesia maintenance.
Chirochaine
Chirochaine 0.5% will be used in regional anesthesia.
Interventions
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Fentanyl
Fentanyl will be used for introduction in both regional and general anesthesia. It will also be used for general anesthesia maintenance.
Propofol
Propofol will be used for introduction in general anesthesia.
Rocuronium
Rocuronium will be used for introduction in general anesthesia.
Chirochaine
Chirochaine 0.5% will be used in regional anesthesia.
Morphine
Morphine will be administered bolus iv in General anesthesia group postoperatively before patients leave OR.
Eligibility Criteria
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Inclusion Criteria
* Native language greek and capable of speaking and writing
* Primary school graduated
* Is about to undergo in orthopedic surgery
* Participants should be available until the end of the prefixed end date of the research
Exclusion Criteria
* Major cognitive impairment (Mini Mental State Examination \<24)
* Medical history of central nervous system disease including stroke with neurological deficit
* Medical history of alcohol or drug abuse
* Dementia, Parkinson disease, Alzheimer disease
* Contraindication for general or regional anesthesia
* Severe contraindication for antiplatelet agent discontinuation
* Multiple failures
* Receiving other coagulants
* No written consent
65 Years
100 Years
ALL
No
Sponsors
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Larissa University Hospital
OTHER
Responsible Party
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Aikaterini Tsiaka, MD
Consultant Anaesthesiologist
Locations
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Larissa University Hospital
Larissa, , Greece
Countries
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Facility Contacts
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Other Identifiers
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5505/19.10.2017
Identifier Type: -
Identifier Source: org_study_id
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