Abstract
One hundred and fortyone 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, noncardiac, major surgical procedures. The average duration of surgery was 1.98 hr and mean dosage of sufentanil was 1.24 μg·kg− 1· hr− 1. Supplemental inhalational anaesthesia was administered to 266 patients (43 per cent). Eightysix patients required naloxone in the immediate postoperative period. Eighty per cent of these patients had received in excess of 1.0 μg· kg− 1·hr− 1 of sufentanil. One hundred and twentynine adverse reactions were reported as disturbing and possibly drugrelated. 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.
Résumé
Cent quarante et un chercheurs de 45 centres canadiens participaient à cette 4ieme phase d’une étude portant sur l’usage du citrate de sufentanil en clinique et impliquant 616 patients de classe ASA I, II ou III. Toutes ces interventions majeures étaient électives et autres que cardiaques. Elles duraient en moyenne 1.98 h avec une dose moyenne de sufentanil de 1.24 μg· kg−1· h−1et ont nécessité l’adjonction d’anesthésiques volatils dans 43 pour cent des cas (266 patients). En post-opératoire immédiat, on a du injecter de la naloxone à 86 patients dont 80 pour cent avaient reçu plus de 1.0 μg· kg−1· h−1 de sufentanil. On a aussi noté 129 “incidents” ennuyeux, possiblement secondaires au médicament dont quatre cas d’arrêt sinusal ou de bradycardie sévère et trente sept cas d’hypotension importante. Cependant, dans tous les cas, on a pu continuer la chirurgie. Les chercheurs ont qualifié de satisfaisantes les phases d’induction, de maintien et d’émergence dans 94, 92 et 93 pour cent des cas respectivement.
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Murkin, J.M. Sufentanil anaesthesia for major surgery: the multicentre Canadian clinical trial. Can J Anaesth 36, 343–349 (1989). https://doi.org/10.1007/BF03010779
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DOI: https://doi.org/10.1007/BF03010779