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[A comparative study of the efficacy and tolerance of dipotassium clorazepate and flunitrazepam for oral premedication]

Author(s): Drautz M, Feucht A, Heuser D

Affiliation(s): Universitatsklinik fur Anaesthesiologie und Transfusionsmedizin Tubingen, Abteilung Anaesthesiologie.

Publication date & source: 1991-12, Anaesthesist., 40(12):651-60.

Publication type: Clinical Trial; Randomized Controlled Trial

The literature shows that benzodiazepines, in view of their anxiolytic, sedative, amnesic, muscle relaxant and anticonvulsive action, are the most important substances for premedication. Eminent workers regard anxiolysis as the most important aim of premedication. In the present clinical study, oral administration of the two different benzodiazepine derivatives, flunitrazepam (F) and chlorazepate dipotassium (CD) have been explored with a view to side effects, tolerance, quality of sleep during the night, anxiolytic effect and sedation. The study involved 108 women patients aged from 20 to 60 years (ASA class I or II), all scheduled to undergo gynecological surgery in general anesthesia. There were also 20 women who received no premedication. The three groups of patients were further divided into early (operation started before 10:30 a.m.) and late-operation (operation started after 10:30 a.m.) groups. The test drugs were administered as follows: 43 women received 50 mg CD p.o. on the evening before the operation, followed by 25 mg p.o. in the morning; 45 women received 2 mg F p.o. on the evening before the operation, followed by 1 mg p.o. in the morning. All patients took the preoperative premedication at 7 o'clock in the morning. Following this medication, the anxiolytic, sedative, and amnesic effects, side effects, vigilance and O2 saturation (SaO2) were determined at defined points during the day of the operation and the 1st postoperative day. Blood pressure and heart rate were recorded and interpreted as physiological stress parameters. Anxiolysis was determined using the Erlangen Anxiety Scale (EAS) of Galster and Sporl; the degree of sedation was assessed by the anesthesiologist; amnesia was determined by the patients' recognition of picture cards; vigilance and side-effects were assessed by standardized questionnaires. Both active drugs clearly improved the quality of sleep in the night before the operation over that experienced with no premedication. There were no significant differences among the three groups in the physiological stress parameters. The preoperative SaO2 saturation was decreased significantly by oral F, but it was always more than 95%. CD had little influence on the SaO2. Unwanted somatic symptoms were found a little more frequently in the group without any premedication. There were no signs of restricted tolerance for either of the test drugs. In the premedicated groups, pre- and postoperative anxiety decreased significantly.(ABSTRACT TRUNCATED AT 400 WORDS)

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