Presented By
Jensen E. Lacsam-Comia, MD
1st year resident
JANUARY 15, 2024
PCGH DEPARTMENT OF ANESTHESIOLOGY
CRITICALLY APPRAISED
TOPIC
CLINICAL SCENARIO
N. P. 35 year old female
nonpregnant, ASA I
Chronic Calculous Cholecystitis
No known comorbidities
For Laparoscopic Cholecystectomy
Intraop
hook to standard ASA monitors (NIBP, ECG and pulse ox) including TOF
Induction of general anesthesia with Rocuronium 0.6 mg/kg
during intraop, patient had stable vital signs except for episode of hypothermia
no other significant events
Post op
during reversal of NMB using Sugammadex, there is a noted delay in emergence
patient was monitored at the PACU and was then transferred awake with stable vital signs
upon rounds, review of post op meds was done, assessed patient for pain level
patient was discharge 2 days post op
Preop Intraop Post Op
Vital signs
BP 120/80 mmHg
80 bpm
20 cpm
BP 110/80 mmHg
70 bpm
19 cpm
BP 120/80 mmHg
75 bpm
20 cpm
Temperature (Patient)
(C)
36.5 35.0 36.2
Ambient temperature
(C)
25 22 25
CLINICAL SCENARIO
QUESTION?
In the reversal of deep rocuronium-induced NMD
with sugammadex, are there any differences in
recovery time for mild hypothermia and for
normal thermal conditions?
Case Scenario Journal
Population 35 years old female ASA I male and female, 21-64 years old ASA I-II
Intervention
General anesthesia using rocuronium with
reversal of sugammadex on hypothermic
patient
General anesthesia using rocuronium with
reversal of sugammadex
Comparison
Recovery duration in mild hypothermia and
northermia condition
Recovery duration in mild hypothermia and
northermia condition
Outcome Reversal duration of 6 minutes
Recovery period: normal thermal condition- 4
minutes
Is the objective of the article comparing therapeutic interventions similar toIs the objective of the article comparing therapeutic interventions similar toIs the objective of the article comparing therapeutic interventions similar to
your clinical dilemma?your clinical dilemma?your clinical dilemma?
Relevance
Back to Agenda
Was the assignments of participants to
intervention randomized?
VALIDITY
GUIDELINES
-Sixty patients of both sexes, ASA physical status I-II, aged between 21-64
years,
-undergoing elective abdominal surgery under general anesthesia
-randomly assigned to either the hypothermia group (n=30) (mild
hypothermia with core temperatures between 34.5C and 35C)
-control group (n=30) (normal thermal condition with core temperatures
between 36.5C and 37C) using computer generated program
PCGH Department of
Anesthesiology
https://bmcanesthesiol.biomedcentral.com/counter/pdf/10.1186/1471-2253-15-7.pdf
Back to Agenda
Was follow-up complete?
VALIDITY
GUIDELINES
PCGH Department of
Anesthesiology
sixty patients were enrolled and neuromuscular monitoring was successfully conducted
no mention drop outs in the study
Back to Agenda
Were patients analyzed in the groups to which they were randomized?
VALIDITY GUIDELINES
PCGH Department of
Anesthesiology
Enrolled participants were analyzed according to the assigned group
mild hypothermia- 30
normothermia - 30
Back to Agenda
Were patients, their clinicians, and study personnel “blind” to treatment?
VALIDITY GUIDELINES
PCGH Department of
Anesthesiology
Anesthesiologist was not mentioned to be blinded in the study
Safety assessor- blinded
PCGH Department of
Anesthesiology
Back to Agenda
Were the study group similar at the start of randomized
control trial?
VALIDITY
GUIDELINES
YesYes
Similarity of two groups:
demographic profile,
anesthetic time,
BIS
end -tidal concentration of sevoflurane,
total dose of rocuronium,
type of surgery,
location of abdominal surgery
core temperature
https://bmcanesthesiol.biomedcentral.com/counter/pdf/10.1186/1471-2253-15-7.pdf
Back to Agenda
Aside from the experimental intervention, were the groups treated equally?
VALIDITY GUIDELINES
PCGH Department of
Anesthesiology
Patients were monitored with ECG, non invasive arterial pressure measurement and pulse
oximetry
Anesthesia used- propofol 2-2.5 mg/kg and remifentanil 0.5 ug/kg/min
Maintained with sevoflurane 1.1-1.6 end tidal and remifentanil 0.1-0.3 ug/kg/min to maintain
a BIS monitor between 40-50 throughout surgery
Sugammadex 4.0 mg/kg
Core temperatures hypothermia group -34.5C-35C; control group- 36.5C-37C
Back to Agenda
OVERALL, IS THE STUDY VALID?OVERALL, IS THE STUDY VALID?
VALIDITY GUIDELINES
PCGH Department of
Anesthesiology
YES
RESULTS
RESULTS
How large was the treatment effect?
https://bmcanesthesiol.biomedcentral.com/counter/pdf/10.1186/1471-2253-15-7.pdf
For normothermia, 83% (25/30) patients recovery time was less than 180s
For hypothermia group 60% (18/30) patients had recovery time of less than 180s
Duration of sugammadex based on
temperature
Risk in Control 25
Risk in treatment 12
Absolute Risk Reduction 0.43
Relative Risk 0.48
Relative Risk Reduction 0.52
P value 0.005
Recovery
time TOF 0.9
(<180s)
Recovery
time TOF 0.9
(>180s)
Mild hypothermia (Y) 12 18
Normothermia
(control X)
25 5
RESULTS
How large was the treatment effect?
For normothermia 83% (25/30)
For hypothermia group 60% (18/30)
In this case, hypothermia increases duration of sugammadex
reversal by 52% . Number of patients needed to treat is 2 . There is
an additional 46 s delay to recover compared with the
normothermia patients.
Clinical Scenario Journal Ideal
Sugammadex
reversal recovery time
(4mg/kg)
200s
Experimental- 171.1 s
Control- 124.9s
174 s
RESULTS
RESULTS
How precise was the estimate of the treatment effect?
-mean recovery time to TOF ratio of 0.9 after sugammadex 4.0 mg/kg
171.1 (62.1)s in the hypothermia group
124.9 (59.2)s in the normothermia group (p=0.005)
-mean arterial pressure during the 180s period following administration of sugammadex was not changed
-heart rate during the same period decreased significantly after sugammadex was administered in both groups (p<0.001)
-Shivering was observed in four patients in the hypothermia group
-PONV and any other adverse effects following administration of sugammadex were not reported in either group
Can the results be applied to my
patient?
Applicability
Were all clinically important outcomes
considered?
Applicability
https://bmcanesthesiol.biomedcentral.com/counter/pdf/10.1186/1471-2253-15-7.pdf
Sugammadex
Bair hugger
(Patient warmer)
Cost P6,834 P600
Availability
Yes but with limited
stocks
Yes
Complication No adverse effect Hyperthermia
Are the likely treatment benefits worth
the potential harm and costs?
Applicability
RESOLUTION TO THE PROBLEM
Continuous monitoring of temperature and maintaining normal
thermal condition of the patient significantly improves the recovery
response in the reversal of Rocuronium induced using sugammadex