The effect of Ro15-1788 (Anexate) on conscious sedation produced with midazolam.

A double-blind cross-over randomised study was performed to investigate whether Ro15-1788 (Anexate) adequately reversed the conscious sedation with midazolam so that patients were clinically recovered and fit for discharge quicker than when midazolam was used alone. Twenty-eight healthy patients between 18 and 34 years sedated with midazolam for bilateral 3rd molar surgery, one side being operated on at each visit. Ro15-1788 or normal saline (placebo) was given at the end of the surgical procedure at the first visit and the alternative at the second visit. Recovery with Ro15-1788 was significantly quicker than with the placebo, both by subjective (86%) and objective (93%) evaluation. Patients' evaluation indicated that only 61% were more alert at home with Ro15-1788. Postoperative adverse effects were similar in both groups.

RCT Entities:   Population Interventions Outcomes