Τίτλος:
Safety and efficacy of analgesia-based sedation with remifentanil versus
standard hypnotic-based regimens in intensive care unit patients with
brain injuries: a randomised, controlled trial [ISRCTN50308308]
Περίληψη:
Introduction This randomised, open-label, observational, multicentre,
parallel group study assessed the safety and efficacy of analgesia-based
sedation using remifentanil in the neuro-intensive care unit.
Methods Patients aged 18-80 years admitted to the intensive care unit
within the previous 24 hours, with acute brain injury or after
neurosurgery, intubated, expected to require mechanical ventilation for
1-5 days and requiring daily downward titration of sedation for
assessment of neurological function were studied. Patients received one
of two treatment regimens. Regimen one consisted of analgesia-based
sedation, in which remifentanil (initial rate 9 mug kg(-1) h(-1)) was
titrated before the addition of a hypnotic agent (propofol [0.5 mg
kg(-1) h(-1)] during days 1-3, midazolam [0.03 mg kg(-1) h(-1)] during
days 4 and 5) (n = 84). Regimen two consisted of hypnotic-based
sedation: hypnotic agent (propofol days 1 - 3; midazolam days 4 and 5)
and fentanyl (n = 37) or morphine (n = 40) according to routine clinical
practice. For each regimen, agents were titrated to achieve optimal
sedation (Sedation - Agitation Scale score 1 - 3) and analgesia (Pain
Intensity score 1 - 2).
Results Overall, between-patient variability around the time of
neurological assessment was statistically significantly smaller when
using remifentanil (remifentanil 0.44 versus fentanyl 0.86 [P = 0.024]
versus morphine 0.98 [P = 0.006]. Overall, mean neurological
assessment times were significantly shorter when using remifentanil
(remifentanil 0.41 hour versus fentanyl 0.71 hour [P = 0.001] versus
morphine 0.82 hour [P < 0.001])). Patients receiving the
remifentanil-based regimen were extubated significantly faster than
those treated with morphine (1.0 hour versus 1.93 hour, P = 0.001) but
there was no difference between remifentanil and fentanyl. Remifentanil
was effective, well tolerated and provided comparable haemodynamic
stability to that of the hypnotic-based regimen. Over three times as
many users rated analgesia-based sedation with remifentanil as very good
or excellent in facilitating assessment of neurological function
compared with the hypnotic-based regimen.
Conclusions Analgesia-based sedation with remifentanil permitted
significantly faster and more predictable awakening for neurological
assessment. Analgesia-based sedation with remifentanil was very
effective, well tolerated and had a similar adverse event and
haemodynamic profile to those of hypnotic-based regimens when used in
critically ill neuro-intensive care unit patients for up to 5 days.
Συγγραφείς:
Karabinis, A
Mandragos, K
Stergiopoulos, S
Komnos, A and
Soukup, J
Speelberg, B
Kirkham, AJT
