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

Larissa University Hospital

Status: Unknown

Conditions: Hip Fractures

Treatments: Drug: Fentanyl; Drug: Propofol; Drug: Rocuronium; Drug: Chirochaine; Drug: Morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT03596060

5505/19.10.2017

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 65 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

General anesthesia

Active Comparator group

Description:

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.

Treatment:

Drug: Morphine

Drug: Rocuronium

Drug: Fentanyl

Drug: Propofol

Regional anesthesia

Active Comparator group

Description:

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.

Treatment:

Drug: Fentanyl

Drug: Chirochaine