Sufentanil anaesthesia for major surgery: the multicentre Canadian clinical trial.

One hundred and forty-one investigators from 45 institutions across Canada participated in the phase 4 clinical trial of sufentanil citrate involving 616 patients. All patients were ASA physical status class I, II, or III, undergoing elective, non-cardiac, major surgical procedures. The average duration of surgery was 1.98 hr and mean dosage of sufentanil was 1.24 micrograms.kg-1.hr-1. Supplemental inhalational anaesthesia was administered to 266 patients (43 per cent). Eighty-six patients required naloxone in the immediate postoperative period. Eighty per cent of these patients had received in excess of 1.0 microgram.kg-1.hr-1 of sufentanil. One hundred and twenty-nine adverse reactions were reported as disturbing and possibly drug-related. Profound bradycardia or sinus arrest was reported in four cases and disturbing hypotension in 37. None of these events required termination of the procedure. The induction, maintenance and recovery phases were rated as good or satisfactory by the participating investigators in 94, 92 and 93 per cent of cases respectively.