search
Back to results

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

Primary Purpose

Hip Fractures

Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Fentanyl
Propofol
Rocuronium
Chirochaine
Morphine
Sponsored by
Larissa University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures focused on measuring hip fracture, general anesthesia, regional anesthesia, clopidogrel, cognitive impairment, mortality

Eligibility Criteria

65 Years - 100 Years (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Larissa University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

General anesthesia

Regional anesthesia

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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
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.
Adverse events postoperatively
Occurrence of adverse events in both General anesthesia and Regional anesthesia groups, especially respiratory, renal, surgical trauma in 30 days postoperatively.
Re-admissions
Re admissions in both General anesthesia and Regional anesthesia groups in 30 days postoperatively.
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).
Time of hospitalization
To check and compare in both General anesthesia and Regional anesthesia groups time to hospital discharge.
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
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
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
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.
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

Full Information

First Posted
June 2, 2018
Last Updated
September 26, 2021
Sponsor
Larissa University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03596060
Brief Title
Regional vs General Anesthesia in Patients With Hip Fracture Under Treatment With Clopidogrel
Official Title
Regional vs General Anesthesia in Patients With Hip Fracture Under Treatment With Clopidogrel
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 20, 2017 (Actual)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Larissa University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
Keywords
hip fracture, general anesthesia, regional anesthesia, clopidogrel, cognitive impairment, mortality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
General anesthesia
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Regional anesthesia
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
Fentanyl will be used for introduction in both regional and general anesthesia. It will also be used for general anesthesia maintenance.
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Propofol will be used for introduction in general anesthesia.
Intervention Type
Drug
Intervention Name(s)
Rocuronium
Intervention Description
Rocuronium will be used for introduction in general anesthesia.
Intervention Type
Drug
Intervention Name(s)
Chirochaine
Intervention Description
Chirochaine 0.5% will be used in regional anesthesia.
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
Morphine will be administered bolus iv in General anesthesia group postoperatively before patients leave OR.
Primary Outcome Measure Information:
Title
Mortality
Description
To compare postoperative 30-day mortality between General anesthesia and Regional anesthesia group
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Major Cardiovascular Events
Description
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.
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
Title
Change in cognitive status
Description
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
Time Frame
Cognitive function will be measured for both groups on admission (preop), 6 months and 12 months postop
Title
Delirium
Description
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.
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)
Title
Adverse events postoperatively
Description
Occurrence of adverse events in both General anesthesia and Regional anesthesia groups, especially respiratory, renal, surgical trauma in 30 days postoperatively.
Time Frame
30 days
Title
Re-admissions
Description
Re admissions in both General anesthesia and Regional anesthesia groups in 30 days postoperatively.
Time Frame
30 days
Title
Postoperative analgesic use
Description
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 Frame
30 days
Title
Time of hospitalization
Description
To check and compare in both General anesthesia and Regional anesthesia groups time to hospital discharge.
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
Title
Adverse events intraoperatively
Description
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
Time Frame
During operation time frame
Title
Functionality in daily living
Description
To check and compare between both General anesthesia and Regional anesthesia groups 6 months postoperatively functionality using Instrumental Activities of Daily Living scale
Time Frame
6 months
Title
Timed Up and Go Test (TUG)
Description
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
Time Frame
Measurements will be assessed 1, 3 and 6 months postop
Title
EQ-5D-5L (EuroQol group, 5 dimensions, 5 levels)
Description
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.
Time Frame
Measurements will be assessed at 1, 3 and 6 months postop
Title
Oxford hip score
Description
To assess function and pain in both General anesthesia and Regional anesthesia groups 1, 3 and 6 months postoperatively by using Oxford hip score
Time Frame
Measurements will be assessed at 1, 3 and 6 months postop

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Larissa University Hospital
City
Larissa
ZIP/Postal Code
41335
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aikaterini Tsiaka, MD, MSc
Phone
00306977298282
Email
ktsiaka@yahoo.gr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs