Abstract
Rilmazafone is a new open-ringed benzodiazepine derivative synthesized in Japan. Preclinical studies have shown its excellent effects inducing and maintaining sleep with little effect on the skeletal muscle. Earlier the clinical dose for this drug as a premedicant was found to be 2-4mg (S-2, S-4). Using 244 patients, we conducted a double blind controlled study of Rilmazafone using nitrazepam 5mg (N-5) as a reference drug to evaluate its usefulness and safety when used as a hypnotic for the pre-operative night and also as a premedicant. Drugs were administered at 8 o'clock on the pre-operative night and 2 hours before operation. Efficacy rate of hypnotic effect was found to be S-4(82%), S-2(69%) and N-5(66%). The incidence of side effects was S-4(52%), S-2(28%) and N-5(39%). Efficacy rate as a premedicant was S-4(75%), S-2(62%) and N-5(75%). Incidence of amnesia was S-4(33%), S-2(15%) and N-5(14%). It was concluded that overall usefulness of the test drugs was in the order of S-4>S-2_??_N-5 for the hypnotic effects for the pre-operative night and in the order of S-4>>S-2_??_N-5 for the premedication.
