Target-controlled versus fractionated propofol sedation in flexible bronchoscopy: A randomized noninferiority trial

Background and objectiveFractionated propofol administration (FPA) in flexible bronchoscopy (FB) may lead to oversedation and an increased risk of adverse events, because a stable plasma concentration of propofol is not maintainable. The purpose of this randomized noninferiority trial was to evaluate whether target-controlled infusion (TCI) of propofol is noninferior to FPA in terms of safety in FB. MethodsCoprimary outcomes were the mean lowest arterial oxygen saturation (SpO(2)) during FB and the number of propofol dose adjustments in relation to procedure duration. Secondary outcomes were the number of occasions with SpO(2)<90% and/or oxygen desaturations of >4% from baseline, number of occasions with systolic blood pressure<90mmHg, cough frequency, cumulative propofol dose, recovery time, maximum transcutaneous CO2, mean SpO(2) and O-2 delivery during FB. ResultsSeventy-seven patients were included. TCI was noninferior to FPA in terms of mean (standard deviation) lowest SpO(2) during the procedure (88.3% (5.4%) vs 86.9% (7.3%)) and required fewer dose adjustments (0.04/min vs 0.28/min, P<0.001) but a higher cumulative propofol dose (264 vs 194mg, P=0.003). All other secondary outcomes were comparable between the groups. ConclusionWe suggest that TCI of propofol is a favourable sedation technique for FB with equal safety issues and fewer dose adjustments compared with FPA. In this randomized noninferiority trial, we evaluated whether target-controlled infusion (TCI) of propofol is noninferior to fractionated administration in terms of safety in flexible bronchoscopy. TCI of propofol is a favourable and safe sedation technique for flexible bronchoscopy.