Prospective, Randomized, Placebo-Controlled Trial Evaluating The Efficacy And Safety Of Propofol Sedation By Anesthesiologists And Gastroenterologist-Led Teams Using Computer-Assisted Personalized Sedation During Upper And Lower Gastrointestinal Endoscopy

Background and Aim: No randomized controlled studies comparing propofol versus no sedation have been reported. Comparative data demonstrating the efficacy and safety of propofol sedation by anesthesiologists (ANES), and gastroenterologist-led teams (GLT) using computer-assisted personalized sedation (CAPS), during routine gastrointestinal (GI) endoscopy in Japan do not exist. We aimed to demonstrate the safety and efficacy of propofol sedation versus no sedation (PLCB) when propofol is given by ANES or GLT, during routine GI endoscopy.Methods: Two hundred and seventy two American Society of Anesthesiologists (ASA) class I or II adults were prospectively enrolled in this multicenter study and randomized into three groups (PLCB, ANES, GLT). Ability to maintain moderate sedation, defined as MOAA/S scores of 2-4 for >= 50% of all MOAA/S measurements from scope-in to scope-out, was the primary endpoint. Secondary endpoints included patient (PSSI) and clinician (CSSI) satisfaction.Results: Proportion of subjects maintained in moderate sedation by ANES (88.1%) and GLT (94.5%) was significantly higher than PLCB (21.6%; P < 0.001); there was no difference between the ANES and GLT groups (P = 0.116). Mean PSSI scores for subjects sedated by ANES (81.2 +/- 12.5) and GLT (80.8 +/- 14.1) were significantly higher than PLCB (65.3 +/- 19.7; P < 0.001) and mean CSSI scores were also significantly higher in both active treatment groups (75.5 +/- 10.2, 77.9 +/- 10.3) than PLCB (60.8 +/- 18.6; P < 0.001).Conclusion: Moderate sedation can be achieved and maintained with propofol, improving both patient and physician satisfaction, when propofol is given by an anesthesiologist or a gastroenterologist-led team using CAPS.