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

Sponsor

Larissa University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03596060

Collaborator

(none)

150

Enrollment

Location

Arms

59.4

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hip Fractures	Drug: Fentanyl Drug: Propofol Drug: Rocuronium Drug: Chirochaine Drug: Morphine	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 20, 2017

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Fentanyl Fentanyl will be used for introduction in both regional and general anesthesia. It will also be used for general anesthesia maintenance. Drug: Propofol Propofol will be used for introduction in general anesthesia. Drug: Rocuronium Rocuronium will be used for introduction in general anesthesia. Drug: Morphine Morphine will be administered bolus iv in General anesthesia group postoperatively before patients leave OR.
Active Comparator: 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.	Drug: Fentanyl Fentanyl will be used for introduction in both regional and general anesthesia. It will also be used for general anesthesia maintenance. Drug: Chirochaine Chirochaine 0.5% will be used in regional anesthesia.

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: Fentanyl

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

Drug: Propofol

Propofol will be used for introduction in general anesthesia.

Drug: Rocuronium

Rocuronium will be used for introduction in general anesthesia.

Drug: Morphine

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

Active Comparator: 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.

Drug: Fentanyl

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

Drug: Chirochaine

Chirochaine 0.5% will be used in regional anesthesia.

Outcome Measures

Primary Outcome Measures

Mortality [30 days]
To compare postoperative 30-day mortality between General anesthesia and Regional anesthesia group

Secondary Outcome Measures

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]
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.
Change in cognitive status [Cognitive function will be measured for both groups on admission (preop), 6 months and 12 months postop]
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
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)]
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.
Adverse events postoperatively [30 days]
Occurrence of adverse events in both General anesthesia and Regional anesthesia groups, especially respiratory, renal, surgical trauma in 30 days postoperatively.
Re-admissions [30 days]
Re admissions in both General anesthesia and Regional anesthesia groups in 30 days postoperatively.
Postoperative analgesic use [30 days]
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).
Time of hospitalization [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]
To check and compare in both General anesthesia and Regional anesthesia groups time to hospital discharge.
Adverse events intraoperatively [During operation time frame]
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
Functionality in daily living [6 months]
To check and compare between both General anesthesia and Regional anesthesia groups 6 months postoperatively functionality using Instrumental Activities of Daily Living scale
Timed Up and Go Test (TUG) [Measurements will be assessed 1, 3 and 6 months postop]
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
EQ-5D-5L (EuroQol group, 5 dimensions, 5 levels) [Measurements will be assessed at 1, 3 and 6 months postop]
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.
Oxford hip score [Measurements will be assessed at 1, 3 and 6 months postop]
To assess function and pain in both General anesthesia and Regional anesthesia groups 1, 3 and 6 months postoperatively by using Oxford hip score

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 100 Years

Sexes Eligible for Study:

All

Accepts 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