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

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 Overview

• Status: Recruiting
• Conditions: Hip Fractures
• Intervention / Treatment: Drug: Fentanyl; Drug: Propofol; Drug: Rocuronium; Drug: Morphine; Drug: Chirochaine

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Larissa, Greece, 41335
    • Recruiting
    • Larissa University Hospital
    • Contact: Aikaterini Tsiaka, MD, MSc; Phone Number: 00306977298282; Email: ktsiaka@yahoo.gr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 100 years (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	To compare postoperative 30-day mortality between General anesthesia and Regional anesthesia group	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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)
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
Re-admissions	Re admissions in both General anesthesia and Regional anesthesia groups in 30 days postoperatively.	30 days
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Larissa University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 20, 2017
• Primary Completion (ANTICIPATED): May 1, 2022
• Study Completion (ANTICIPATED): October 1, 2022

Study Registration Dates

• First Submitted: June 2, 2018
• First Submitted That Met QC Criteria: July 19, 2018
• First Posted (ACTUAL): July 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 26, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: hip fracture, general anesthesia, regional anesthesia, clopidogrel, cognitive impairment, mortality
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Fentanyl; Propofol; Morphine; Rocuronium
• Other Study ID Numbers: 5505/19.10.2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No