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

Hip Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03596060
• Other study ID #: 5505/19.10.2017
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2017
• Est. completion date: October 2022

Study information

• Verified date: September 2021
• Source: Larissa University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Greece	Larissa University Hospital	Larissa

Sponsors (1)

Lead Sponsor	Collaborator
Larissa University Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	To compare postoperative 30-day mortality between General anesthesia and Regional anesthesia group	30 days
Secondary	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.	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
Secondary	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	Cognitive function will be measured for both groups on admission (preop), 6 months and 12 months postop
Secondary	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.	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)
Secondary	Adverse events postoperatively	Occurrence of adverse events in both General anesthesia and Regional anesthesia groups, especially respiratory, renal, surgical trauma in 30 days postoperatively.	30 days
Secondary	Re-admissions	Re admissions in both General anesthesia and Regional anesthesia groups in 30 days postoperatively.	30 days
Secondary	Postoperative analgesic use	Use of analgesics (pethidine, paracetamol), counted in milligrams as a mean per day, from the time patients are transfered to the orthopedic ward until 30 days postop in both General anesthesia and Regional anesthesia groups targeting Numerical Rating Scale score <4 (range is from 0 to 10 and a higher score indicates greater pain intensity).	30 days
Secondary	Time of hospitalization	To check and compare in both General anesthesia and Regional anesthesia groups time to hospital discharge.	Time to discharge will be considered the time duration from date of surgery until the date of discharge or date of death from any cause while hospitalised, whichever came first, assessed up to 1 month
Secondary	Adverse events intraoperatively	To check and compare in both General anesthesia and Regional anesthesia groups incidence of low blood pressure (< 20% from baseline), bradycardia (<50 bpm), hemorrhage and need of blood transfusions, use of antifibrinolytics intraoperatively	During operation time frame
Secondary	Functionality in daily living	To check and compare between both General anesthesia and Regional anesthesia groups 6 months postoperatively functionality using Instrumental Activities of Daily Living scale	6 months
Secondary	Timed Up and Go Test (TUG)	To determine fall risk and measure the progress of balance, sit to stand, and walking using Timed Up and Go Test (TUG) and compare these attributes between General anesthesia and Regional anesthesia groups 1, 3 and 6 months postoperatively	Measurements will be assessed 1, 3 and 6 months postop
Secondary	EQ-5D-5L (EuroQol group, 5 dimensions, 5 levels)	With the use of EQ-5D-5L to check and compare between General anesthesia and Regional anesthesia groups 1, 3 and 6 months postoperatively mobility, self-care, usual activities, pain/discomfort and anxiety/depression.	Measurements will be assessed at 1, 3 and 6 months postop
Secondary	Oxford hip score	To assess function and pain in both General anesthesia and Regional anesthesia groups 1, 3 and 6 months postoperatively by using Oxford hip score	Measurements will be assessed at 1, 3 and 6 months postop