Gammahydroxybutyric 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 gamma-hydroxybutyric acid-ethanolamide (GH B-ethanolamide) was compared with midazolam for sedation of patients in the intensive care unit (ICU). GHB-ethanolamide is a new derivative of gammahy droxybutyric acid, a drug commonly used for sedation in intensive care pati ents. Methods. A total of 29 non-intubated, spontaneously breathing patients foll owing major surgery, were randomly assigned to 2 groups: group A (n=14) rec eived 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 comp uterized EEG recording (CATEEM (R)). Results. EEG: the SFx showed a significantly deeper sedation compared to ba seline values, 10, 60 a nd 120 min after sta rt of sedation in the GHB-etha nolamide group. By contrast, no difference could be observed compared to ba seline values in the midazolam group. A comparison between both groups show ed a deeper sedation in the GHB group 60 and 120 min after start of sedatio n. 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 se dation 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 midazola m with regards to side effects such as respiratory depression.