Critical Appraisal

Randomised Controlled Trial of Sugammadex or

Neostigmine for Reversal of Neuromuscular Block on
the Incidence of Pulmonary Complications in Older
Adults Undergoing Prolonged Surgery

Nur Fadilla
1706098695

Supervisor : dr. Arif H.M. Marsaban, SpAn-KAP, KAA

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 Inclusion criteria : Patients having elective surgery, aged ≥70
yr, scheduled for surgery of ≥3 h under GA and without a
surgical or medical contraindication to neuromuscular block.

Exclusion criteria : Kidney disease (stage ≥4),

liver disease (AST or ALT>2x normal), allergies to
study drugs, and refusal of consent.

Randomization
Intervention : receive IV Control : receive IV
sugammadex 2mg/kg neostigmine 0.07 mg/kg

Incidence of postoperative pulmonary

complications and proportion of patients with
residual neuromuscular block in the PACU
PICO Analysis

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 Patients

Patients having elective surgery at

Oregon Health and Science
University between January 2017
and March 2018, aged ≥70 years,
scheduled for surgery expected
duration of ≥3 hours under general
anesthesia, and without
contraindication to neuromuscular
block

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Intervention

IV sugammadex 2mg/kg

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Comparison

IV neostigmine 0.07 mg/kg

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 Outcome

Incidence of postoperative
pulmonary complications
and proportion of patients
with residual neuromuscular
block in the PACU

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Are the results of this single
preventive or therapeutic trial
valid?

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Was the assignment of
patients to treatment
randomized?
And was the
randomization list
concealed?

Yes

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Were measures objective
or were the patients and
clinicians kept “blind” to
which treatment was
being received?

Yes

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Aside from the experimental
treatment, were the groups
treated equally?

The protocol of anesthesia

management in this research
were not clearly stated except
about the experimental
treatment

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Are the valid results of this
randomised trial important?

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Postoperative pulmonary complication
  Postoperative pulmonary No postoperative
complication pulmonary
complication
Sugammadex 33 67
Neostigmine 40 60

    Relative Risk Absolute Risk Number Needed to

Reduction (RRR) Reduction Treat (NNT)
(ARR)

   
Control Event Rate Experimental Event CER – EER
CER – EER 1/ARR
(CER) Rate CER
(ERR)
40/100 = 0.4 33/100 = 0.33 0.175 0.07 14.28

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Residual neuromuscular block
  Residual neuromuscular No residual
block (TOF <0.9) neuromuscular block
(TOF >0.9)
Sugammadex 9 91
Neostigmine 46 54

    Relative Risk Absolute Risk Number Needed

Reduction (RRR) Reduction (ARR) to Treat (NNT)

Control Event Experimental CER – EER    

CER – EER 1/ARR
Rate (CER) Event Rate CER
(ERR)
46/100 = 0.46 9/100 = 0.09 0.80 37/100 = 0.37 2.70

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Can you apply this valid,
important evidence about a
treatment in caring for your
patient?

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• Is your patient so different from those in the trial that its
results can’t help you?
Yes, the sample population was Caucasian different from our patients

• How great would the potential benefit of therapy actually be

for your individual patient?
It would be great to reduce residual neuromuscular block during
prolonged operation especially in vulnerable population such as
geriatric patient

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Are your patient’s values and preferences satisfied by
the regimen and its consequences?
• Do your patient and you have a clear assessment of their values
and preferences?
Yes, anesthesiologist and patients have value the safest dan the best
anesthesia care

• Are they met by this regimen and its consequences?

Yes, but to be considered, sugammadex more expensive than
neostigmine. This issue may trouble for some anesthesiologist/patients

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Thank You

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