[Gamma-hydroxybutyric acid-ethanolamide (LK 544). The suitability of LK 544 for sedation of patients in intensive care in comparison with midazolam].
OBJECTIVE
In this phase 2 study gammahydroxybutyric acid-ethanolamide (GHB-ethanolamide) was compared with midazolam for sedation of patients in the intensive care unit (ICU). GHB-ethanolamide is a new derivative of gammahydroxybutyric acid, a drug commonly used for sedation in intensive care patients.


METHODS
A total of 29 non-intubated, spontaneously breathing patients following major surgery, were randomly assigned to 2 groups: group A (n = 14) received 150 mg/kg GHB-ethanolamide i.v. followed by 150 mg/kg/h. Group B (n = 15) received 0.025 mg/kg midazolam i.v. followed by 0.025 mg/kg/h. The degree of sedation was assessed over a 3-5 h period both clinically by the Ramsay Score and by the spectral frequency index (SFx), derived by continuous computerized EEG recording (CATEEM).


RESULTS
EEG: the SFx showed a significantly deeper sedation compared to baseline values, 10, 60 and 120 min after start of sedation in the GHB-ethanolamide group. By contrast, no difference could be observed compared to baseline values in the midazolam group. A comparison between both groups showed a deeper sedation in the GHB group 60 and 120 min after start of sedation. The Ramsay Score increased from baseline values of 2.0 (2.0/2.0) to 3.0 (2.0/3.0) during sedation (Median (25th/75th percentile) and no significant differences could be observed between groups. In the Midazolam group the sedation of two patients had to be terminated because of side effects (Ramsay Score 6 and paradoxical, agitated reaction).


CONCLUSIONS
GHB-ethanolamide produces adequate sedation for extubated and spontaneously breathing ICU patients. The drug might be safer than midazolam with regards to side effects such as respiratory depression.
Soltész
S
S
Klinik für Anaesthesiologie und Intensivmedizin der Universitätskliniken des Saarlandes, 66421 Homburg/Saar. aissol@med-rz.uni-sb.de
Silomon
M
M
Biedler
A
A
Kleinschmidt
S
S
Benak
J
J
Molter
G P
GP
D000328:Adult; D016292:Procedural Sedation; D003422:Critical Care; D004311:Double-Blind Method; D004569:Electroencephalography / Q000187:drug effects; D005260:Female; D006439:Hemodynamics / Q000187:drug effects; D006801:Humans; D006993:Hypnotics and Sedatives / Q000009:adverse effects; D008297:Male; D008874:Midazolam / Q000009:adverse effects; D008875:Middle Aged; D005680:gamma-Aminobutyric Acid / Q000009:adverse effects* / Q000031:analogs & derivatives
D006993:Hypnotics and Sedatives; C431546:hydroxybutyryl ethanolamide; D005680:gamma-Aminobutyric Acid; D008874:Midazolam