Introduction Esophagogastroduodenoscopy (EGD) is usually done under conscious sedation. In the USA most EGDs are performed with a combination of a short-acting benzodiazepine and a narcotic. The benefit of using one or two drugs has remained unproven.
Objective To evaluate adequacy, tolerance and possible differences in security of conscious sedation in upper endoscopy using midazolam alone vs midazolam plus fentanyl.
Materials and Method We included patients older than 18 years old who underwent elective, diagnostic outpatient EGD. Patients where randomized to receive either the combination of fentanyl/midazolam (F/M) or midazolam alone (M). The dose of medication was decided by the endoscopist. The adequacy of sedation obtained was assessed with a questionnaire answered by the physician at the end of the procedure and by the patient 24-72 hours after endoscopy. Patients were contacted by telephone and asked (1) about their tolerance classified as excellent/good vs fair/poor; (2) degree of recollection of the procedure: none or vague recollection vs remembers good part of it/everything; and (3) level of pain during the procedure: none or mild vs moderate or extreme discomfort.
Results We collected data from 71 patients. Thirty-four patients were assigned to the M group and 37 to the F/M group. Deviation of protocol or early termination because of poor tolerance occurred in 4 patients in the M group and 2 in the F/M group. Based on the endoscopist evaluation, there was no difference in the patient's tolerance: excellent/good in 63.3% of patients in the M group and 82.8% in the F/M group (p: .074). We were not able to contact one patient after EGD (M group). Per patient's assessment: excellent/good tolerance was found in 93% of the M group and 94% in the F/M group (p: 1.0); no or minimal recollection in 82.8% (F/M) vs 89.6% (M) (p: .49); no/mild discomfort in 91.4% in the F/M group vs 93.1% in the M group (p: 1). No difference in duration of the procedure was found between the 2 groups. No complications during endoscopies were reported. Mean dose of midazolam in the single-drug group was 3.5 mg and 2.5 mg in the combination group. Mean dose of fentanyl was 78.5 μg.
Conclusion In diagnostic upper endoscopy an adequate level of sedation can be obtained safely with either midazolam or midazolam + fentanyl.