A PLACEBO-CONTROLLED STUDY OF FLUMAZENIL IN BRONCHOSCOPIC PROCEDURES

Methods A double-blind, randomized, placebo controlled trial of the ef ficacy of flumazenil was conducted in 22 consecutive patients admitted for bronchoscopy. Sedation was induced by individually titrated amoun ts of intravenous diazepam (mean +/- s.d., 15.7 +/- 4.4 mg). Post bron choscopy, patients received up to 1 mg of the benzodiazepine antagonis t flumazenil (Anexate(R)) or placebo intravenously. Clinical scores fo r the degree of sedation, orientation in time and space, co-operation and antergrade amnesia were used. These, together with three psychomet ric tests were performed twice prior to bronchoscopy and on eight occa sions in the following 24 h. The psychometric tests were: Tapping Test (TT), Simple Reaction Time (SRT) and Critical Flicker Fusion (CFF) an d these were carried out using the automated Multipsy test system. Res ults The level of co-operation, orientation in time and space and ante rograde amnesia were similar in both groups pre-and-post procedure. Ho wever compared with the pre-bronchoscopy assessment, the maximum degre e of apparent sedation was significantly less in the flumazenil group in the first 4 h. In support of this, the patients in the flumazenil g roup also showed a significantly greater proficency with the TT and CF F test post bronchoscopy (P<0.05). There was no difference in the inci dence of side effects and flumazenil was well tolerated. Conclusions I n this highly controlled setting, the use of flumazenil (Anexate(R)) w as shown to be safe and effective in aiding recovery from benzodiazepi ne facilitated bronchoscopy and as such provides an additional level o f safety for this procedure.