BACKGROUND AND OBJECTIVE:Fractionated 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. METHODS: Coprimary outcomes were the mean lowest arterial oxygen saturation (SpO2 ) during FB and the number of propofol dose adjustments in relation to procedure duration. Secondary outcomes were the number of occasions with SpO2 < 90% and/or oxygen desaturations of >4% from baseline, number of occasions with systolic blood pressure < 90 mmHg, cough frequency, cumulative propofol dose, recovery time, maximum transcutaneous CO2 , mean SpO2 and O2 delivery during FB. RESULTS:Seventy-seven patients were included. TCI was noninferior to FPA in terms of mean (standard deviation) lowest SpO2 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 194 mg, P = 0.003). All other secondary outcomes were comparable between the groups. CONCLUSION: We suggest that TCI of propofol is a favourable sedation technique for FB with equal safety issues and fewer dose adjustments compared with FPA.
RCT Entities:
BACKGROUND AND OBJECTIVE: Fractionated 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. METHODS: Coprimary outcomes were the mean lowest arterial oxygen saturation (SpO2 ) during FB and the number of propofol dose adjustments in relation to procedure duration. Secondary outcomes were the number of occasions with SpO2 < 90% and/or oxygen desaturations of >4% from baseline, number of occasions with systolic blood pressure < 90 mm Hg, cough frequency, cumulative propofol dose, recovery time, maximum transcutaneous CO2 , mean SpO2 and O2 delivery during FB. RESULTS: Seventy-seven patients were included. TCI was noninferior to FPA in terms of mean (standard deviation) lowest SpO2 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 194 mg, P = 0.003). All other secondary outcomes were comparable between the groups. CONCLUSION: We suggest that TCI of propofol is a favourable sedation technique for FB with equal safety issues and fewer dose adjustments compared with FPA.
Authors: Tobias Müller; Kristina Thümmel; Christian G Cornelissen; Stefan Krüger; Michael Dreher Journal: PLoS One Date: 2017-04-12 Impact factor: 3.240