Double-blind study of the reversal of midazolam-supplemented general anaesthesia with Ro 15-1788.

The actions and side effects of the benzodiazepine antagonist Ro 15-1788 were evaluated in a randomized double-blind clinical study in which midazolam was used as an anaesthetic agent. Sixty women who underwent laparoscopy were treated with Ro 15-1788 or with placebo after the surgical procedure. Ro 15-1788 reversed the hypnotic effect of midazolam within a few minutes. The patients were alert, co-operative, oriented and had good recall of events after awakening. The effects were statistically better than placebo for up to 30 min after administration. Arterial pressure and heart rate remained stable and there were no significant side effects. The availability of Ro 15-1788 allows effective reversal of midazolam when this is used during general anaesthesia.