Background & aims: In the United States, upper gastrointestinal endoscopy is usually performed using intravenous sedation. Sedation increases the rate of both complications and costs of endoscopy. Unsedated esophagogastroduodenoscopy (EGD) using conventional 8-11-mm endoscopes is an alternative to sedated endoscopy but is generally perceived as unacceptable to many American patients. Unsedated EGD using ultrathin 5-6-mm endoscopes is better tolerated. A randomized trial comparing unsedated ultrathin EGD (UT-EGD) with sedated conventional EGD (C-EGD) in a diverse American population is needed.
Methods: In this multicenter, randomized, controlled trial, 80 patients scheduled to undergo elective outpatient EGD were randomized to unsedated UT-EGD or sedated C-EGD. The study was carried out at San Francisco General Hospital, San Francisco Veterans Affairs Medical Center, and the Liver and Digestive Health Medical Clinic, San Jose.
Results: Baseline characteristics of patients randomized to unsedated UT-EGD and sedated C-EGD were similar. Moreover, there were no significant differences in overall patient satisfaction and willingness to repeat endoscopy in the same manner among the 2 study groups. There was, however, a significant difference in median total procedure time between the 2 study groups of 1.5 hours (P < 0.0001). The mean (+/- SD) total procedure cost was 512.4 US dollars (+/- 100.8 US dollars) for sedated C-EGD and 328.6 US dollars (+/- 70.3 US dollars) for unsedated UT-EGD (P < 0.0001).
Conclusions: Patients undergoing unsedated UT-EGD are as satisfied as patients undergoing sedated C-EGD and are just as willing to repeat an unsedated UT-EGD. Unsedated UT-EGD was also faster, less costly, and may allow greater accessibility to this procedure.