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Spinal Anesthesia or General
Anesthesia for Hip Surgery in
Older Adults
Journal Club Evaluation
Pharm D Candidate
Zeinab Noormonavar
20062022
1
2
Outline
At the end of the presentation we’ll be able to:
 Recall the overview of Hip Fracture in elderly
 Identify the classification and pharmacological treatment modalities
 Learn the different drugs used
 Evaluate the journal and methodology used and the results achieved
3
Introduction
As the population ages, the number of hip fractures
continues to increase.
Older patients have weaker bone and are more
likely to fall.
It could be due to poorer balance, medication side
effects, and difficulty maneuvering around
environmental hazards.
4
Risk Factors
Osteoporosis Falls Low socioeconomic
status
Cardiovascular disease
Endocrine disease
(Hyperthyroidism,
Diabetes)
Medications (BDZ,
opioids,
antidepressant)
Weaken bone BMI <22
5
Medical Management
Analgesia
Anesthesia:
Propofol,
Etomidate,
Ketamine
Opioids:
Fentanyl,
Sufentanil,
Alfentanil,
Morphine &
Hydromorphone
Thromboemb
olic
Prophylaxis
LMWH
DOACs
Aspirin
UFH
Fondaparinox
Warfarin
Infection
Prophylaxis
Cephazolin
Clindamycin /
Vancomycin
±
Aminoglycoside,
Aztreonam,
Fluoroquinolone
Beta
Blockers
Atenolol
Metoprolol
Bisoprolol
Delirium
Lorazepam
Rivastigmine
Osteoporosis
Zolendronic
Acid
Risedronate
Surgery
6
Medical Management (con’t)
Indication of Surgery
• Surgery is indicated for most patients
with hip fracture.
• Mortality rate is 4x higher in patients
who choose non-operative treatment.
• Surgical repair often provides better
and more rapid pain control and
improved mobility, even in bed.
Timing of Surgery
• For all patients, avoid delaying surgery
beyond 72 hours.
• In patients who are medically stable and
without significant comorbid illness, surgery
should be performed within 24 hours.
• Delay in surgical repair will result in
postponement of full weight-bearing status,
leading to delayed functional recovery.
• In patients with comorbid medical illness,
surgery should also be performed as soon as
feasible.
7
8
Journal Evaluation
9
• NEJM is the world’s leading medical journal and website.
• NEJM publishes weekly, 52 times per year.
• NEJM has highest Journal impact factor (91.245) of all general medical journal. (2020 Journal
Citation Reports)
• NEJM maintains more than 30,000 peer reviewers worldwide in all areas of medicine.
• This journal has deputy editors, associate editors and statistical consultants that cross work
together to finalize editing.
• NEJM is indexed in PUBMED and MEDLINE
• NEJM follows the CONSORT guideline.
Journal Evaluation (Cont’d)
• In low-income countries where resources are limited, NEJM provides free full-text
access
• Published continuously for over 200 years.
• Delivers high quality, peer-reviewed research and interactive clinical content to
physicians, educators, and global medical community.
• More than 19 specialties including: Endocrinology, Nephrology, Cardiology, Oncology
and Dermatology.
• NEJM employs a rigorous peer review and editing process to evaluate all manuscripts
for scientific accuracy, novelty and importance.
10
Consort Checklist
11
Title Evaluation
Strengths Missing
12
TO BE:
Multi center, randomized,
double blinded, placebo-
controlled, event-driven trials
of Rivaroxaban 2.5 mg (BID) in
patient with Heart Failure,
Sinus Rhythm, and Coronary
Disease.
Authors and Authors Evaluation
M.D. Neuman
Associate Professor , Anesthesiology and Critical Care, Perelman School of Medicine
Is a practicing anesthesiologist and health services researcher.
His research focuses on improving patient-centered outcomes for older adults undergoing
surgery and anesthesia.
Board certificate of Anesthiology 2020
R. Feng
Is an anesthesiologist in Stanford, California. He received his medical degree from
Cleveland Clinic Lerner College of Medicine and has been in practice between 6-10 years.
Board Certification: National Board of Echocardiography, Perioperative Trans esophageal
Echocardiography (2021)
Board Certification: American Board of Anesthesiology, Anesthesia (2021)
J.L Carson
Is the Provost, New Brunswick at Rutgers Biomedical and Health Sciences and served as Chief of the
Division of General Internal Medicine until 2015.
Dr. Carson is a board-certified internist who practices office and hospital-based Internal Medicine.
expertise in clinical trials has been recognized by his appointment to Clinical Trials Review Committee at
the National Heart, Lung and Blood Institutes where he served as Chair during his fifth year 13
 Most of the authors are
physicians specialized in
anesthesia.
 All authors have participated
in other studies and
publications related to
anesthesia & hip fracture.
 Their information are easily
accessible to anyone.
 No affiliation with
pharmaceutical company.
 There are enough number of
statistician for the accuracy of
study.
Funding of Study
Patient-Centered Outcomes Research Institute
• Is a United States-based non-profit institute created through the 2010 Patient
Protection and Affordable Care Act.
• It is a government-sponsored organization charged with funding comparative
effectiveness research that assists consumers, clinicians, purchasers, and policy
makers to make informed decisions intended to improve health care at both the
individual and population levels, according to the Institute of Medicine.
14
Abstract Evaluation
15
The Rational behind study is clearly stated and is
similar to the one in the article.
• Study design and characteristic are mentioned.
• Primary efficacy and secondary efficacy
outcomes are mentioned.
• Length of study is mentioned.
 Are similar to the one in article.
• The result paradelle to the objective and the
same CI and P-value as well as the number of
patients included in trial.
• Number of patients is included.
• Conclusion is the same as in the article.
• No clinical recommendation.
• Funded by Patient-Centered Outcomes
Research Institute®
Introduction Evaluation
Nearly all patients with hip
fracture undergo surgery,
most commonly with spinal
anesthesia or general
anesthesia.
Spinal anesthesia may be
associated with lower risks of
death, delirium, and major
medical complications. It is
associated with shorter
lengths of stay in the hospital
than general anesthesia.
Randomized trials have shown
conflicting results regarding
the effectiveness of different
types of anesthesia in
different patients' recovery
from hospital admission.
Most of trials outcome did
not take into consideration
due to lack of enough number
of participant, lack of
assessment beyond hospital
stay and also more than 30
years are conducted.
16
Rationale and Objective
Patients may view recovery of independence in walking after hip fracture
as a priority, but studies evaluating the effect of anesthesia technique on
this outcome are lacking.
We conducted a trial to evaluate the recovery of walking ability after
receipt of spinal as compared with general anesthesia for hip-fracture
surgery in older adults who could walk independently before the
fracture
We hypothesized that patients assigned to receive spinal anesthesia
would be more likely to be alive and walking independently at 60 days
than those assigned to receive general anesthesia.
17
Ethical Consideration
18
 This study is approved by IRB and Helsinki declaration is applied.
It’s stated that:
Study Design
• Multicenter (Conducted in 46 hospitals in US & Canada)
• Randomized Superiority Trial
• 1:1
• Pragmatic: to evaluate the effectiveness of interventions in real-life routine practice
conditions
• Stratified Permuted Block
19
20
Inclusion
Criteria
clinically or
radiographically
diagnosed with femoral
neck, intertrochanteric,
or subtrochanteric hip
fracture
Schedule to undergo
surgical repair
50 years of age or older
21
Exclusion
criteria
If the patient was at
risk for malignant
hyperthermia
If they had previously
participated in the trial
If the patient had
contraindications to
spinal anesthesia (use of
anticoagulant or antiplatelet
medications, critical or severe
aortic stenosis, a high risk of
infection by spinal needle
insertion site, or elevated ICP)
If the fracture was
periprosthetic
If a concurrent
procedure that was
not amenable to spinal
anesthesia was
planned
If they had not been able to
walk approximately 3 m or
Across a room without the
assistance of another
person before the fracture
Efficacy Outcome
22
Primary Outcome
Death after 60 days of
randomization
New inability to walk (3 m)
after 60 days of randomization
Secondary Outcome
Death within 60 days
Delirium, time to discharge,
and ambulation at 60 days
Statistical Analysis
23
Method
24
Patient
assigned for
eligibility
Patient
underwent
randomization
Assign to
receive spinal
anesthesia
Had available
data for
primary
outcome
Were included
in primary
outcome
analysis
Assign to
receive
general
anesthesia
Had available
data for
primary
outcome
Were included
in primary
outcome
analysis
From Feb 2016 till Feb 2021
Trial participants and treating
clinicians were aware of the
treatment assignments.
Using permuted block
randomization
Data were reviewed at pre-specified
intervals by an independent data
and safety monitoring board
Randomization was stratified
according to hospital, sex, and
fracture location (femoral neck vs.
intertrochanteric or subtrochanteric
fracture)
Site staff obtained each
randomization assignment
from the data-management
system Web portal and
communicated it to the
treating anesthesia team.
Randomization and Trial Regimen
Anesthesia was administered by the
usual clinical anesthesia staff at each
site
For spinal anesthesia, providers
administered a single-injection spinal
anesthetic with sedation as needed for
patient comfort
sedation was adjusted to ensure an
Observer’s Assessment of
Alertness/Sedation (OAAS) scale17
score between 5 (“Responds readily to
name spoken in normal tone”) and 2
(“Responds only after mild shaking or
prodding”)
Crossover to general anesthesia was
permitted on the basis of clinical
circumstances or patient request
For general anesthesia, providers used
an inhaled anesthetic agent for
maintenance, with the choice of agent
conforming to their usual practice, and
to use an endotracheal tube, supra
glottic airway, or another device for
airway management in accordance
with local practice
25
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Journal Club Evaluation (Anesthisia).pptx

  • 1. Spinal Anesthesia or General Anesthesia for Hip Surgery in Older Adults Journal Club Evaluation Pharm D Candidate Zeinab Noormonavar 20062022 1
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  • 3. Outline At the end of the presentation we’ll be able to:  Recall the overview of Hip Fracture in elderly  Identify the classification and pharmacological treatment modalities  Learn the different drugs used  Evaluate the journal and methodology used and the results achieved 3
  • 4. Introduction As the population ages, the number of hip fractures continues to increase. Older patients have weaker bone and are more likely to fall. It could be due to poorer balance, medication side effects, and difficulty maneuvering around environmental hazards. 4
  • 5. Risk Factors Osteoporosis Falls Low socioeconomic status Cardiovascular disease Endocrine disease (Hyperthyroidism, Diabetes) Medications (BDZ, opioids, antidepressant) Weaken bone BMI <22 5
  • 6. Medical Management Analgesia Anesthesia: Propofol, Etomidate, Ketamine Opioids: Fentanyl, Sufentanil, Alfentanil, Morphine & Hydromorphone Thromboemb olic Prophylaxis LMWH DOACs Aspirin UFH Fondaparinox Warfarin Infection Prophylaxis Cephazolin Clindamycin / Vancomycin ± Aminoglycoside, Aztreonam, Fluoroquinolone Beta Blockers Atenolol Metoprolol Bisoprolol Delirium Lorazepam Rivastigmine Osteoporosis Zolendronic Acid Risedronate Surgery 6
  • 7. Medical Management (con’t) Indication of Surgery • Surgery is indicated for most patients with hip fracture. • Mortality rate is 4x higher in patients who choose non-operative treatment. • Surgical repair often provides better and more rapid pain control and improved mobility, even in bed. Timing of Surgery • For all patients, avoid delaying surgery beyond 72 hours. • In patients who are medically stable and without significant comorbid illness, surgery should be performed within 24 hours. • Delay in surgical repair will result in postponement of full weight-bearing status, leading to delayed functional recovery. • In patients with comorbid medical illness, surgery should also be performed as soon as feasible. 7
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  • 9. Journal Evaluation 9 • NEJM is the world’s leading medical journal and website. • NEJM publishes weekly, 52 times per year. • NEJM has highest Journal impact factor (91.245) of all general medical journal. (2020 Journal Citation Reports) • NEJM maintains more than 30,000 peer reviewers worldwide in all areas of medicine. • This journal has deputy editors, associate editors and statistical consultants that cross work together to finalize editing. • NEJM is indexed in PUBMED and MEDLINE • NEJM follows the CONSORT guideline.
  • 10. Journal Evaluation (Cont’d) • In low-income countries where resources are limited, NEJM provides free full-text access • Published continuously for over 200 years. • Delivers high quality, peer-reviewed research and interactive clinical content to physicians, educators, and global medical community. • More than 19 specialties including: Endocrinology, Nephrology, Cardiology, Oncology and Dermatology. • NEJM employs a rigorous peer review and editing process to evaluate all manuscripts for scientific accuracy, novelty and importance. 10
  • 12. Title Evaluation Strengths Missing 12 TO BE: Multi center, randomized, double blinded, placebo- controlled, event-driven trials of Rivaroxaban 2.5 mg (BID) in patient with Heart Failure, Sinus Rhythm, and Coronary Disease.
  • 13. Authors and Authors Evaluation M.D. Neuman Associate Professor , Anesthesiology and Critical Care, Perelman School of Medicine Is a practicing anesthesiologist and health services researcher. His research focuses on improving patient-centered outcomes for older adults undergoing surgery and anesthesia. Board certificate of Anesthiology 2020 R. Feng Is an anesthesiologist in Stanford, California. He received his medical degree from Cleveland Clinic Lerner College of Medicine and has been in practice between 6-10 years. Board Certification: National Board of Echocardiography, Perioperative Trans esophageal Echocardiography (2021) Board Certification: American Board of Anesthesiology, Anesthesia (2021) J.L Carson Is the Provost, New Brunswick at Rutgers Biomedical and Health Sciences and served as Chief of the Division of General Internal Medicine until 2015. Dr. Carson is a board-certified internist who practices office and hospital-based Internal Medicine. expertise in clinical trials has been recognized by his appointment to Clinical Trials Review Committee at the National Heart, Lung and Blood Institutes where he served as Chair during his fifth year 13  Most of the authors are physicians specialized in anesthesia.  All authors have participated in other studies and publications related to anesthesia & hip fracture.  Their information are easily accessible to anyone.  No affiliation with pharmaceutical company.  There are enough number of statistician for the accuracy of study.
  • 14. Funding of Study Patient-Centered Outcomes Research Institute • Is a United States-based non-profit institute created through the 2010 Patient Protection and Affordable Care Act. • It is a government-sponsored organization charged with funding comparative effectiveness research that assists consumers, clinicians, purchasers, and policy makers to make informed decisions intended to improve health care at both the individual and population levels, according to the Institute of Medicine. 14
  • 15. Abstract Evaluation 15 The Rational behind study is clearly stated and is similar to the one in the article. • Study design and characteristic are mentioned. • Primary efficacy and secondary efficacy outcomes are mentioned. • Length of study is mentioned.  Are similar to the one in article. • The result paradelle to the objective and the same CI and P-value as well as the number of patients included in trial. • Number of patients is included. • Conclusion is the same as in the article. • No clinical recommendation. • Funded by Patient-Centered Outcomes Research Institute®
  • 16. Introduction Evaluation Nearly all patients with hip fracture undergo surgery, most commonly with spinal anesthesia or general anesthesia. Spinal anesthesia may be associated with lower risks of death, delirium, and major medical complications. It is associated with shorter lengths of stay in the hospital than general anesthesia. Randomized trials have shown conflicting results regarding the effectiveness of different types of anesthesia in different patients' recovery from hospital admission. Most of trials outcome did not take into consideration due to lack of enough number of participant, lack of assessment beyond hospital stay and also more than 30 years are conducted. 16
  • 17. Rationale and Objective Patients may view recovery of independence in walking after hip fracture as a priority, but studies evaluating the effect of anesthesia technique on this outcome are lacking. We conducted a trial to evaluate the recovery of walking ability after receipt of spinal as compared with general anesthesia for hip-fracture surgery in older adults who could walk independently before the fracture We hypothesized that patients assigned to receive spinal anesthesia would be more likely to be alive and walking independently at 60 days than those assigned to receive general anesthesia. 17
  • 18. Ethical Consideration 18  This study is approved by IRB and Helsinki declaration is applied. It’s stated that:
  • 19. Study Design • Multicenter (Conducted in 46 hospitals in US & Canada) • Randomized Superiority Trial • 1:1 • Pragmatic: to evaluate the effectiveness of interventions in real-life routine practice conditions • Stratified Permuted Block 19
  • 20. 20 Inclusion Criteria clinically or radiographically diagnosed with femoral neck, intertrochanteric, or subtrochanteric hip fracture Schedule to undergo surgical repair 50 years of age or older
  • 21. 21 Exclusion criteria If the patient was at risk for malignant hyperthermia If they had previously participated in the trial If the patient had contraindications to spinal anesthesia (use of anticoagulant or antiplatelet medications, critical or severe aortic stenosis, a high risk of infection by spinal needle insertion site, or elevated ICP) If the fracture was periprosthetic If a concurrent procedure that was not amenable to spinal anesthesia was planned If they had not been able to walk approximately 3 m or Across a room without the assistance of another person before the fracture
  • 22. Efficacy Outcome 22 Primary Outcome Death after 60 days of randomization New inability to walk (3 m) after 60 days of randomization Secondary Outcome Death within 60 days Delirium, time to discharge, and ambulation at 60 days
  • 24. Method 24 Patient assigned for eligibility Patient underwent randomization Assign to receive spinal anesthesia Had available data for primary outcome Were included in primary outcome analysis Assign to receive general anesthesia Had available data for primary outcome Were included in primary outcome analysis From Feb 2016 till Feb 2021 Trial participants and treating clinicians were aware of the treatment assignments. Using permuted block randomization Data were reviewed at pre-specified intervals by an independent data and safety monitoring board Randomization was stratified according to hospital, sex, and fracture location (femoral neck vs. intertrochanteric or subtrochanteric fracture) Site staff obtained each randomization assignment from the data-management system Web portal and communicated it to the treating anesthesia team.
  • 25. Randomization and Trial Regimen Anesthesia was administered by the usual clinical anesthesia staff at each site For spinal anesthesia, providers administered a single-injection spinal anesthetic with sedation as needed for patient comfort sedation was adjusted to ensure an Observer’s Assessment of Alertness/Sedation (OAAS) scale17 score between 5 (“Responds readily to name spoken in normal tone”) and 2 (“Responds only after mild shaking or prodding”) Crossover to general anesthesia was permitted on the basis of clinical circumstances or patient request For general anesthesia, providers used an inhaled anesthetic agent for maintenance, with the choice of agent conforming to their usual practice, and to use an endotracheal tube, supra glottic airway, or another device for airway management in accordance with local practice 25
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