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

NCT03596060 | Unknown

• 1 other identifier: 5505/19.10.2017
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hip Fractures

Keywords

hip fracture, general anesthesia, regional anesthesia, clopidogrel, cognitive impairment, mortality

Outcome Measures

Primary Outcomes (1)

• Mortality

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

  30 days

Secondary Outcomes (12)

• Major Cardiovascular Events

  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

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

• Delirium

  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

  30 days

• Re-admissions

  30 days

Study Arms (2)

General anesthesia

ACTIVE COMPARATOR

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.

Drug: Fentanyl; Drug: Propofol; Drug: Rocuronium; Drug: Morphine

Regional anesthesia

ACTIVE COMPARATOR

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.

Drug: Fentanyl; Drug: Chirochaine

Interventions

Fentanyl DRUG

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

General anesthesia; Regional anesthesia

Propofol DRUG

Propofol will be used for introduction in general anesthesia.

General anesthesia

Rocuronium DRUG

Rocuronium will be used for introduction in general anesthesia.

General anesthesia

Chirochaine DRUG

Chirochaine 0.5% will be used in regional anesthesia.

Regional anesthesia

Morphine DRUG

Morphine will be administered bolus iv in General anesthesia group postoperatively before patients leave OR.

General anesthesia

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Larissa University Hospital: lead

Study Sites (1)

Larissa University Hospital

Larissa, 41335, Greece

RECRUITING

MeSH Terms

Conditions

Hip Fractures; Cognitive Dysfunction

Interventions

Fentanyl; Propofol; Rocuronium; Morphine

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anaesthesiologist

Study Record Dates

• First Submitted: June 2, 2018
• First Posted: July 23, 2018
• Study Start: October 20, 2017
• Primary Completion: May 1, 2022
• Study Completion: October 1, 2022
• Last Updated: September 28, 2021

Record last verified: 2021-09

Locations

GR (1)