Aim: To compare the endomicroscopic image quality of integrated confocal laser endomicroscopy (iCLE) and sedation efficacy of propofol vs midazolam plus fentanyl (M/F).
Methods: Consecutive outpatients undergoing iCLE were prospectively recruited and randomized to the propofol group (P group) or M/F group. The patient, performing endoscopist and endoscopic assistant were blinded to the randomization. The quality of endomicroscopic images and anesthetic efficacy outcomes were blindly evaluated after iCLE examination.
Results: There were significantly more good quality endomicroscopic images in the propofol group than in the M/F group (72.75% vs 52.89%, P < 0.001). The diagnostic accuracy for upper gastrointestinal mucosal lesions using confocal laser endomicroscopy favors the P group, although this did not reach statistical significance. Adverse events and patient assessment were not significantly different for M/F vs propofol except for more frequent intraprocedural recall with M/F. Procedure duration and sedation times were significantly longer in the M/F group, while the scores of endoscopist, anesthetist and assistant assessment were all significantly better in the P group.
Conclusion: Sedation with propofol might increase the proportion of good quality endomicroscopic images, and may result in improved procedural efficacy and diagnostic accuracy during iCLE examination.
Keywords: Confocal laser endomicroscopy; Conscious sedation; Image quality; Randomized trial; Sensitivity and specificity.