Small caliber esophagogastroduodenoscopy without sedation: A prospective study of healthy volunteers

Introduction: A significant portion of the cost and potential complications of esophagogastroduodenoscopy (EGD) are related to the use of sedation. Limited studies have reported the feasibility of unsedated EGD in subjects undergoing upper endoscopy. Aim: To assess the technical feasibility and tolerability of unsedated small caliber transoral EGD (sc-EGD) in a group of healthy volunteers. Methods: All procedures were performed with the Pentax small caliber video esophagogastroduodenoscope (EG-1840, outside diameter 6 mm, biopsy channel 2 mm) by two experienced staff endoscopists. The pharynx of each subject was sprayed with 20% benzocaine. Intravenous midazolam in a sufficient dose to cause drowsiness was used for sedation. Initially, 20 volunteers under-went sc-EGD with sedation (Phase I) to assess the technical feasibility (the ability to reach the 2^nd portion of the duodenum). Subsequently, the tolerability was determined by having another group of 20 volunteers undergo sc-EGD without sedation and comment on the overall acceptability, and the degree of choking, sore throat, and discomfort on a scale of 1 to 10 (Phase II). Statistical analysis was performed by the t-Test for paired samples assuming equal variances. Results: The age of the volunteers ranged from 20 to 47 years (mean 34.5, median 36.5) in the sedated and 20 to 58 years (mean 36, median 39) in the unsedated group. 80% of the subjects were female in the sedated and 75% in the unsedated group. In Phase I of the study, the 2^nd portion of the duodenum was reached in all cases. In Phase II, all volunteers found the procedure tolerable and were willing to undergo unsedated sc-EGD again if medically indicated. Compared to sedated sc-EGD, unsedated sc-EGD was associated with only slightly increased choking and discomfort as summarized below. The degree of sore throat was not significantly different (*1 = none/most acceptable, 10 = most severe/least acceptable; values represent medians and range;*NS = not significant, p>0.05) Sedated sc-EGD*Unsedated sc-EGD*P value # Choking 1 (1-2) 3 (1-6) <0.0001 Sore Throat 1 (1-6) 1 (1-5) NS Discomfort 1(1-4) 2(1-5) <0.005 Acceptability 1 (1-3) 2 (1-5) <0.005 Willingness to Repeat 100% 100% NS Summary: Small caliber EGD is feasible with or without sedation. The tolerability of unsedated sc-EGD as assessed by the overall acceptability, and the degree of choking, sore throat, and discomfort, is comparable to the tolerability of sedated sc-EGD. All subjects who underwent sc-EGD without sedation were willing to undergo the procedure again if medically indicated. Conclusion: Unsedated sc-EGD is feasible and tolerable and may become the procedure of choice in a selected group of subjects if its diagnostic accuracy is demonstrated in a larger series of patients. Elimination of sedation can potentially decrease the complexity, complications, and costs of EGD with sedation and allow convenient safe examinations outside the traditional endoscopy unit setting.