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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03596060
Recruitment Status : Recruiting
First Posted : July 23, 2018
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Aikaterini Tsiaka, MD, Larissa University Hospital

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 20, 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Mortality [ Time Frame: 30 days ]
    To compare postoperative 30-day mortality between General anesthesia and Regional anesthesia group


Secondary Outcome Measures :
  1. Major Cardiovascular Events [ Time Frame: 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.

  2. Change in cognitive status [ Time Frame: 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

  3. Delirium [ Time Frame: 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.

  4. Adverse events postoperatively [ Time Frame: 30 days ]
    Occurrence of adverse events in both General anesthesia and Regional anesthesia groups, especially respiratory, renal, surgical trauma in 30 days postoperatively.

  5. Re-admissions [ Time Frame: 30 days ]
    Re admissions in both General anesthesia and Regional anesthesia groups in 30 days postoperatively.

  6. Postoperative analgesic use [ Time Frame: 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).

  7. Time of hospitalization [ Time Frame: 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.

  8. Adverse events intraoperatively [ Time Frame: 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

  9. Functionality in daily living [ Time Frame: 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

  10. Timed Up and Go Test (TUG) [ Time Frame: 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

  11. EQ-5D-5L (EuroQol group, 5 dimensions, 5 levels) [ Time Frame: 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.

  12. Oxford hip score [ Time Frame: 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



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Ages Eligible for Study:   65 Years to 100 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03596060


Locations
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Greece
Larissa University Hospital Recruiting
Larissa, Greece, 41335
Contact: Aikaterini Tsiaka, MD, MSc    00306977298282    ktsiaka@yahoo.gr   
Sponsors and Collaborators
Larissa University Hospital

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Responsible Party: Aikaterini Tsiaka, MD, Consultant Anaesthesiologist, Larissa University Hospital
ClinicalTrials.gov Identifier: NCT03596060    
Other Study ID Numbers: 5505/19.10.2017
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aikaterini Tsiaka, MD, Larissa University Hospital:
hip fracture, general anesthesia, regional anesthesia, clopidogrel, cognitive impairment, mortality
Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Fentanyl
Morphine
Anesthetics
Propofol
Clopidogrel
Rocuronium
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action