Efficacy of lorazepam oral fast dissolving drug formulation (FDDF) in anesthesia premedication in adults: a double-blind placebo controlled comparison.

Lorazepam 4 mg oral fast dissolving drug formulation was compared to placebo in a double-blind study as premedicant in adult anesthesia. Lorazepam induced in this trial a marked relief of anxiety after 60 minutes without changes in vital parameters nor in reflex activity or muscle tonus. Anterograde amnesia was present in about 60 percent of the patients. The clinical anesthetists rated the quality of premedication as satisfactory or better in 77 percent of lorazepam treated patients. The rating as "good" or "excellent" by patients reached 93 percent. The incidence of side effects was low. Postoperative residual effects on attention, cognitive, somatic and visceral functions were present till 5 hours postmedication. Lorazepam FDDF (fast dissolving drug formulation) appeared to be an effective and clinically safe premedicant for its good anxiolytic and amnestic effect and its high acceptance by the patients. Its use is not recommended for outpatient anesthesia because it prolongs recovery from anesthesia.

RCT Entities:   Population Interventions Outcomes