Background: The benefit of using one or two drugs for conscious sedation in upper endoscopy remains unproven. This study evaluates the adequacy of conscious sedation during upper endoscopy using midazolam alone compared with midazolam plus fentanyl.
Methods: Patients older than 18 years of age who underwent elective, outpatient upper endoscopy were included. They were randomized to receive either a combination of midazolam/fentanyl or midazolam alone. The adequacy of sedation obtained was assessed using a questionnaire answered by the physician at the end of the procedure, and by the patient 24 to 72 hours after endoscopy.
Results: From the endoscopist's perspective, following an intention-to-treat analysis, patients had better tolerance in the combination group (78.3% excellent/good tolerance M/F group versus 55.8% M group) (P = 0.043) (Table 2). Per patient's assessment excellent/good tolerance was found in 93% of M group and 94% in F/M group (P = 1.0). No difference in duration of the procedure was found between the two groups. No complications during endoscopies were reported.
Conclusions: In diagnostic upper endoscopy, an adequate level of sedation can be obtained safely either by midazolam or midazolam plus fentanyl. From an endoscopist's perspective, the combination is significantly better.