Critical Appraisal Topic

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Critical Appraisal Topic
Acquil Mohammad U. Alip, MD
Resident
Dept. of Anesthesiology
UP-PGH
Manila, Philippines
The Question:
Is Propofol better than Midazolam in
giving conscious sedation to patients
undergoing interventional radiology?
 As a resident rotator in TCVS/Cath lab,
I want to know which drug/s is/are more
safe and effective in patient undergoing
interventional radiological procedures.
 Key words: Conscious Sedation, Propofol,
Midazolam, Interventional radiology.

Search Engine
The find

Conscious sedation in interventional
radiology: A comparison of Propofol
versus Midazolam
Anagha U. Manjrekar, M.D.
Deepa Kane, M.D
Lalita Dewoolkar, M.D.
Prerana Shroff, M.D.
Department of Anaesthesiology
Seth G.S.Medical College and
K.E.M.Hospital Mumbai India
Terminology
Conscious sedation-once referred to as
“twilight sleep”has become popular to
describe a semi-conscious state that
allows patients to be comfortable during
certain surgical or medical procedures
Stages of Sedation according to ASA:
1. minimal sedation, you will feel relaxed, and you
may be awake.You can understand and answer
questions and will be able to follow your physician’s
instructions.
2. moderate sedation, you will feel drowsy and may
even sleep through much of the procedure, but will
be easily awakened when spoken to or touched. You
may or may not remember being in the procedure
room.
3. deep sedation, you will sleep through the
procedure with little or no memory of the
procedure room. Your breathing can slow, and you
might be sleeping until the medications wear off.
With deep sedation, supplemental oxygen is often
given.
Journal Abstract

Most interventional radiological
procedures are minimally painful, possibly
prolonged and require relative patient
immobility, and pose a challenge to the
anesthesiologist of providing adequate
sedation, immobilization and analgesia
without compromising airway or
consciousness and ensuring rapid
recovery
Journal Abstract
Randomized, double-blinded study
 Compared Propofol and Midazolam with
respect to safety and efficacy
 60 patients
 Grouped into :
A- Midazolam+Fentanyl
B- Propofol+Fentanyl
All patients received 1μg.kg -1 fentanyl
i.v. before access area was prepared and
draped

Group A patients received 15μg/kg
Midazolam bolus followed by an infusion
@ 0.5μg.kg/min
 group B received a bolus of Propofol
0.5mg/kg followed by an infusion @
25μg/kg/min
 bolus dose of fentanyl 25μg was
administered as needed for excessive pain

Appraising Validity
Q1: Were patients randomly assigned to treatment
group?
A- Yes
 60 ASA 1/11/111 were assigned to group A and B
for Interventional radiological procedure
 Patients with anticipated difficult airway,
hemodynamic instability, impaired vision; bronchial
asthma, IHD, uncompensated hepatic or renal
disease and pregnant or lactating patients were
excluded from the study by a thorough preanesthetic evaluation.
Q2: Was allocation concealed?
A- Not mentioned
 Q3: Were baseline characteristics similar
at the start of the trial?
A- Yes

Table 1: Demographic Data
Q4: Were patients blinded to treatment
assignment?
A- Yes, they were not informed which
drug will be given to them
Q5: Were caregivers blinded to the
treatment assignment?
A- Not mentioned
Q6: Were outcome assessors blinded to
treatment assignment?
A- Not mentioned
Q7: Were patients analyzed in the groups to
which they were originally randomized?
A- Yes
Steward’s score were assessed 10
minutes after the procedure completed
Memory
of seeing picture chart and
needle prick were assessed at 30 minutes
Post Anesthesia Discharge Score (PADSS)
3 was assessed at six hours to assess
intermediate recovery
No dropout nor non-compliant patient
Q8: Was follow-up rate adequate?
A- Yes
No drop-outs or non-compliant patient
Results

Q1: How large was the treatment effect?
Table 3: Haemodynamics (Blood Pressure And Heart Rate)
Table 4: Respiratory Parameters (Mean Respiratory Rate And
Oxygen Saturation)
Table 5: Amnesia
Table 6: Sedation Score
Table 7:Visual Analogue Score (Operator And Patient)
Table 8: Recovery Score At 10 Minutes After Completion Of
Procedure
Table 9: Discharge Score
Table 10: Adverse Effects
Conclusion

Authors found that both techniques of
conscious sedation, Midazolam and
Propofol; with Fentanyl were satisfactory
for interventional radiological procedures
with respect to:
◦
◦
◦
◦
◦
haemodynamics,
respiratory parameters,
sedation,
amnesia,
recovery,
◦ satisfaction of patient and operator and
complications
◦ Improving analgesia could possibly improve
patient coopertion and thus operator
comfort
◦ Propofol though costlier, by ensuring rapid
recovery and thus reducing hospital stay may
emerge superior and cost effective compared
to Midazolam
Assessing Applicability
The results of this study can be applied in
our hospital in giving anesthesia to
patient/s undergoing interventional
radiological procedures
 Drawback:

◦ The inclusion/exclusion was limited, patient
with IHD were excluded, the coronary
angiogram was not included in the
interventional procedure

Drawbacks:
◦ In the study, it was not mentioned what
method they used to make sure that the
patient and the operator were really blinded
in the procedure.
Conclusion
both techniques of conscious sedation, Midazolam
and Propofol; with Fentanyl were satisfactory for
interventional radiological procedures with
respect to haemodynamics, respiratory
parameters, sedation, amnesia, recovery,
satisfaction of patient and operator and
complications. Improving analgesia could possibly
improve patient co-opeartion and thus operator
comfort
 Propofol though costlier, by ensuring rapid
recovery and thus reducing hospital stay may
emerge superior and cost effective compared to
Midazolam

Assalamu Alaikom
THANK YOU!