As. Camps et al., Midazolam and 2% propofol in long-term sedation of traumatized, criticallyill patients: Efficacy and safety comparison, CRIT CARE M, 28(11), 2000, pp. 3612-3619
Objective: We proposed to compare the efficacy and safety of midazolam and
propofol in its new preparation (2% propofol) when used for prolonged, deep
sedation in traumatized, critically ill patients. We also retrospectively
compared 2% propofol with its original preparation, 1% propofol, used in a
previous study in a similar and contemporary set of patients.
Design: A prospective, randomized, unblinded trial (midazolam and 2% propof
ol) and a retrospective, contemporary trial (2% propofol and 1% propofol).
Settings: A trauma intensive care unit in a tertiary university hospital.
Patients. A total of 63 consecutive trauma patients, admitted within a peri
od of 5 months and requiring mechanical ventilatory support for >48 hrs, 43
of whom (73%) suffered severe head trauma. We also retrospectively compare
d the 2% propofol group with a series of patients in whom 1% propofol was u
sed.
Interventions: For the prospective trial, we randomized two groups-a midazo
lam group with continuous administration of midazolam at dosages 0.1-0.35 m
g/kg/hr, and a 2% propofol group with continuous infusion at dosages 1.5-6
mg/kg/hr. Equal dosages of analgesics were administered. Similar management
protocols were applied in the 1% propofol group, used in retrospective ana
lysis with 2% propofol.
Measurements and Main Results: Epidemiologic and efficacy variables were re
corded. Hemodynamic and biochemical variables were also monitored on a regu
lar basis. Neuromonitoring was also performed on those patients with head t
rauma. Sedation adequacy was similar and patient behavior after drug discon
tinuation was not different in either prospective group (midazolam and 2% p
ropofol). Hemodynamic or neuromonitoring variables were also similar for bo
th groups. Triglyceride levels were significantly higher in the 2% propofol
group compared with the midazolam group. A higher number of therapeutic fa
ilures because of sedative inefficacy was seen in the 2% propofol group com
pared with the midazolam group, especially during the first sedation days.
When comparing 2% propofol and 1% propofol, a significantly higher number o
f therapeutic failures because of hypertriglyceridemia were found in the 1%
propofol group, as opposed to a major number of therapeutic failures becau
se of inefficacy, found in the 2% propofol group.
Conclusions: Propofol's new preparation is safe when used in severely traum
atized patients. Its more concentrated formula improves the lipid overload
problem seen with the prolonged use of the previous preparation. Neverthele
ss, a major number of therapeutic failures were detected with 2% propofol b
ecause of the need for dosage increase. This fact could he caused by a diff
erent disposition and tissue distribution pattern of both propofol preparat
ions. New studies will be needed to confirm these results.