• S Soltész, M Silomon, A Biedler, S Kleinschmidt, J Benak, and G P Molter.
• Klinik für Anaesthesiologie und Intensivmedizin der Universitätskliniken des Saarlandes, 66421 Homburg/Saar. aissol@med-rz.uni-sb.de
• Anaesthesist. 2001 May 1; 50 (5): 323-8.

ObjectiveIn 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.MethodsA 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).ResultsEEG: 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).ConclusionsGHB-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.

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