A phase 2 clinical trial comparing Ro 48-6791, a new short-acting benzodiazepine, with propofol for induction of anaesthesia.
A phase 2, single-blinded, randomized, multicentre trial was conducted to compare recovery times from anaesthesia between patients induced with a new short-acting benzodiazepine Ro 48-6791 (Hoffman-La Roche, Sydney, N.S.W.) or propofol. Seventy-six patients were randomly allocated to receive either Ro 48-6791 or propofol for induction followed by a standardized anaesthetic. Alertness and ambulatory function during recovery were scored by a rater blinded to treatment group. Mean time to awakening was longer for the Ro 48-6791 group (15 min), compared with propofol (7 min, P < 0.001), as was mean time to full clinical recovery (116 min vs 75 min respectively, P = 0.002). Both groups showed similar cardiovascular stability following induction, but shorter apnoea times were demonstrated for Ro 48-6791 (48s vs 133, P < 0.001). The longer recovery times with Ro 48-6791 would make this drug a less suitable sole induction agent than propofol for routine use in day stay surgery. Further studies of Ro 48-6791 should pay particular attention to the effect of dose reduction on recovery profile.
Wrigley
P J
PJ
Department of Anaesthesia, Princess Alexandra Hospital, Brisbane.
Elliott
D W
DW
Blake
D
D
D000759:Adjuvants, Anesthesia / Q000008:administration & dosage; D000328:Adult; D000762:Anesthesia Recovery Period; D018686:Anesthetics, Intravenous; D014151:Anti-Anxiety Agents / Q000008:administration & dosage; D001569:Benzodiazepines; D017558:Elective Surgical Procedures; D005260:Female; D006801:Humans; D008297:Male; D015742:Propofol; D013997:Time Factors
D000759:Adjuvants, Anesthesia; D018686:Anesthetics, Intravenous; D014151:Anti-Anxiety Agents; D001569:Benzodiazepines; C104519:Ro 48-6791; D015742:Propofol