Additional subcutaneous administration of flumazenil does not shorten recovery time after midazolam.

We assessed the efficacy of subcutaneous administration of flumazenil (Anexate, Roche), a specific benzodiazepine antagonist, in preventing resedation after initial reversal of midazolam sedation in 30 patients (ASA I-II) undergoing gynaecological surgery. In the post-operative period, the patients received flumazenil i.v. and placebo s.c. (group A), flumazenil i.v. and flumazenil s.c. (group B), or placebo i.v. and placebo s.c. (control group) in a randomized, double-blind procedure. Flumazenil (group A: 0.47 (SD 0.12) mg i.v., group B: 0.48 (0.06) mg i.v.) was significantly more effective than placebo in antagonizing the sedative effects of midazolam, but was accompanied by rebound sedation after 90 min. Additional s.c. administration of flumazenil 0.1 mg (group B) did not eliminate resedation. Undesirable side effects include nausea and vomiting. Local tolerance of the subcutaneous administration of flumazenil was good.

RCT Entities:   Population Interventions Outcomes