Baylor University Medical Center Proceedings January 2014, Volume 27, Number 1 | Page 8

No patients in either group had observed episodes of decreased respiratory rate. When looking
at all recorded respiratory rates, the dexmedetomi13 withdrawn prior to randomization
dine group had a larger percentage (49% vs 40%)
5 no overnight ICU or PACU stay
of respiratory rates within the normal range of 10
3 serious adverse events
3 withdrew consent
to 18 breaths per minute (Figure 4). Placebo sub1 surgery cancelled
jects had respiratory rates higher than the normal
1 dexmedetomidine not continued
overnight
range more frequently than dexmedetomidine
subjects (60% vs 51%), although this difference
was not statistically significant (P = 0.08).
38 subjects randomized
Comparing all subjects, the tcpCO2 was in the
normal range of 38 to 42 mm Hg for 24% of the
time while receiving study drug. The tcpCO2 was
19 randomized to receive 0.1 to
19 randomized to receive 0.1 to
>42 mm Hg for 56% of the time for all subjects,
0.5 µg·kg·h-1 dexmedetomidine
0.5 µg·kg·h-1 placebo
and the mean tcpCO2 was similar across the two
groups when looking at all times combined (P =
3 withdrawn prior to end of
1 withdrawn prior to end of
0.58). During hours 6 to 16, the mean tcpCO2
infusion:
infusion:
of the two groups was statistically different (42
1 hypotension
1 hypovolemia
1 pneumonia, sepsis
± 8 mm Hg vs 45 ± 9 mm Hg, P = 0.02) with a
1 withdrew consent
higher mean tcpCO2 for the placebo group (Figure 5). During this same timeframe, the mean
19 included in analysis
19 included in analysis
pain scores for the dexmedetomidine and placebo
groups were similar (3 ± 2.3 vs 3 ± 2.2, P = 0.59),
Figure 2. Participant flow.
but the mean RSS was significantly different
(2 ± 0.3 vs 2 ± 0, P = 0.006).
A total of 43 adverse events were reported for
750 minutes of study drug, the third patient, randomized to
all 51 patients (Table 3). Three of the adverse events—which inthe dexmedetomidine group, was diagnosed with pneumonia
cluded cardiac arrest, multiple organ dysfunction syndrome, and
and experienced tachycardia and hypotension. This patient
Stokes-Adams attacks—necessitated subject withdrawal prior
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