• Minerva stomatologica · Jul 2011

    Randomized Controlled Trial Comparative Study

    Comparison by means of bispectral index score, between anxiolysis induced by diazepam and sedation induced by midazolam.

    • G Manani, E Facco, L Favero, G A Favero, G Favero, M Berengo, E Stellini, E Bressan, C Bacci, S Sivolella, S Sivollela, M Mazzuchin, and G Zanette.
    • Department of Medico-Surgical Specialties, University of Padua, Italy.
    • Minerva Stomatol. 2011 Jul 1;60(7-8):365-81.

    AimBispectral Index Score (BIS) is an objective tool to assess sedation depth. Benzodiazepines have different pharmacological profiles and diazepam may be safer than midazolam in this setting. The aim of this study was to compare BIS values observed during anxiolysis after diazepam versus sedation after midazolam.MethodsThirty-six patients were randomly assigned to 3 groups: group 1 was treated with i.v. diazepam, groups 2 and 3 with iv midazolam 1 and 3 mg, respectively. Sedation was monitored clinically and by means of BIS. BIS values were evaluated as area under the curve (AUC) and compared by variance analysis. The statistical comparison of other data was performed by variance analysis or, alternatively, the χ2 according to Yates. The statistical significance was indicated by P values <0.05.ResultsAUC values were significantly lower after midazolam when compared to AUC values registered in diazepam treated patients; 22.6% of the group 3 patients showed BIS values <80, versus 0.4% of group 1 patients.ConclusionDiazepam has a safer profile, with BIS values and clinical conditions according to the definition of minimal and/or moderate sedation. Diazepam represents the safer drug for anxiety management in dentistry, because regularly produces a state of sedation during which verbal contact with the patient is maintained and carry a margin of safety wide enough to render loss of consciousness unlikely.

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