A prospective, randomized, placebo controlled trial evaluating the efficacy and safety of propofol sedation by anesthesiologists and by gastroenterologist-led teams using computer-assisted personalized sedation during upper and lower GI endoscopy

Background

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 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 administered by ANES, or GLT, during routine GI endoscopy.

Methods

Two hundred and seventy two ASA class I or II adults were prospectively enrolled in this multicenter study, randomized into three groups (PLCB, ANES, GLT). The ability to maintain moderate sedation, defined as MOAA/S scores of 2 to 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.

Result

The 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). The 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 the 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).

Conclusions

Moderate sedation can be achieved and maintained with propofol, improving both patient and physician satisfaction, when propofol is administered by an anesthesiologist, or a gastroenterologist-led team, using CAPS.

(ClinicalTrial.gov NCT01961349)

from #Esophageal Cancer via a.lsfakia on Inoreader http://ift.tt/27kXPts
via IFTTT