Regional vs General Anesthesia in Patients With Hip Fracture Under Treatment With Clopidogrel

Larissa University Hospital150 enrolled

Overview

This study compares general to regional anesthesia concerning morbidity and mortality in patients older than or equal to 65 years old who receive clopidogrel and are to be submitted in hip fracture surgery. Half of participants will receive general anesthesia the first 48 hours and the other half will receive regional anesthesia after 5 days of the discontinuation of clopidogrel.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

150

Conditions

Hip Fractures

Interventions

FentanylDRUG

Fentanyl will be used for introduction in both regional and general anesthesia. It will also be used for general anesthesia maintenance.

PropofolDRUG

Propofol will be used for introduction in general anesthesia.

RocuroniumDRUG

Rocuronium will be used for introduction in general anesthesia.

Eligibility

Sex: ALLMin age: 65 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients older than or equal to 65 years old with hip fracture * 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: * Severe hearing impairment and visual acuity * 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

Locations (1)

Larissa University Hospital

Larissa, Greece

RECRUITING

Outcomes

Primary Outcomes

Mortality

To compare postoperative 30-day mortality between General anesthesia and Regional anesthesia group

Time frame: 30 days

Secondary Outcomes

Major Cardiovascular Events

To check and compare between General anesthesia and Regional anesthesia group for major cardiovascular events (arrhythmias, stroke, cardiac arrest, acute myocardial infract, acute respiratory oedema, pulmonary embolism) postoperatively in 30 days and 3, 6, 12 months.

Time frame: Events will be recorded for both groups from date of surgery postop up to 12 months or date of death from any cause, with intermediate recordings in 1, 3 and 6 months periods in survivors

Change in cognitive status

To measure and compare, between General anesthesia and Regional anesthesia group, Cognitive status using Mini Mental State Examination and Clock Test before surgery and 6, 12 months postoperatively

Time frame: Cognitive function will be measured for both groups on admission (preop), 6 months and 12 months postop

Delirium

Occurrence of delirium and comparison between General anesthesia and Regional anesthesia group with the use of Confusion Assessment Method before surgery and in 2, 3, 4 and 7 days postoperatively.

Time frame: Occurrence of delirium will be measured, for both groups, on admission (preop) and days 2, 3, 4 and 7 postop (two tests per day, morning and evening hours)

Adverse events postoperatively

Occurrence of adverse events in both General anesthesia and Regional anesthesia groups, especially respiratory, renal, surgical trauma in 30 days postoperatively.

Time frame: 30 days

Re-admissions

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.