BACKGROUND:Topical pharyngeal anesthesia is required to perform a technically adequate esophago-gastroduodenoscopy (EGD), but does not improve patient satisfaction, comfort, and willingness to repeat, particularly in the elderly and those with increased pharyngeal sensitivity. The comparative effectiveness of intravenous sedation versus no sedation remains poorly characterized. OBJECTIVE: To compare the effectiveness of diagnostic EGD with and without intravenous sedation in an adult Thai population. MATERIAL AND METHOD: A randomized controlled trial assigned patients into two groups, group C (topical pharyngeal anesthesia alone) and group I (intravenous sedation and topical pharyngeal anesthesia). All patients were topicalized with lidocaine viscous and spray. The patients in group I were sedated with midazolam 0.035 mg x kg(-1) and maintained with continuous propofol infusion. The ease of procedure and patient tolerance were evaluated. Secondary outcomes included patient and endoscoptist satisfaction, total time to awake, and willingness to repeat the procedure. RESULTS:One hundred and seventy patients (mean age 50.5, 41.2% male) were randomized (group C = 85 and group I = 85; intervention) into two groups. Among patients of the two groups, 100% of the procedures were "successful". In group C, 98.8% were satisfied with their level of tolerance (comfort) while the group I had 100%. The willingness to repeat was 6.2 +/- 1.6 in group C while group I had 9.4 +/- 0.8. Patient and endoscopist satisfaction in group I was more satisfied than in group C (90.6% vs 35.3% and 81.2% vs 40.0% respectively) (p < 0.001). In group I, total amount of propofol was 91.6 +/- 45.5 mg and total time to awake was 8.2 +/- 4.2 min. The use of sedation was the major determinant of patient satisfaction, but contributed to an increased recovery room time. Hypertension and tachycardia were the most complications in group C, and hypotension was the most complication in group I. CONCLUSION: In the average Thai adult population, sedated diagnostic EGD is a good strategy to increase endoscopist satisfaction and willingness to repeat.
RCT Entities:
BACKGROUND: Topical pharyngeal anesthesia is required to perform a technically adequate esophago-gastroduodenoscopy (EGD), but does not improve patient satisfaction, comfort, and willingness to repeat, particularly in the elderly and those with increased pharyngeal sensitivity. The comparative effectiveness of intravenous sedation versus no sedation remains poorly characterized. OBJECTIVE: To compare the effectiveness of diagnostic EGD with and without intravenous sedation in an adult Thai population. MATERIAL AND METHOD: A randomized controlled trial assigned patients into two groups, group C (topical pharyngeal anesthesia alone) and group I (intravenous sedation and topical pharyngeal anesthesia). All patients were topicalized with lidocaine viscous and spray. The patients in group I were sedated with midazolam 0.035 mg x kg(-1) and maintained with continuous propofol infusion. The ease of procedure and patient tolerance were evaluated. Secondary outcomes included patient and endoscoptist satisfaction, total time to awake, and willingness to repeat the procedure. RESULTS: One hundred and seventy patients (mean age 50.5, 41.2% male) were randomized (group C = 85 and group I = 85; intervention) into two groups. Among patients of the two groups, 100% of the procedures were "successful". In group C, 98.8% were satisfied with their level of tolerance (comfort) while the group I had 100%. The willingness to repeat was 6.2 +/- 1.6 in group C while group I had 9.4 +/- 0.8. Patient and endoscopist satisfaction in group I was more satisfied than in group C (90.6% vs 35.3% and 81.2% vs 40.0% respectively) (p < 0.001). In group I, total amount of propofol was 91.6 +/- 45.5 mg and total time to awake was 8.2 +/- 4.2 min. The use of sedation was the major determinant of patient satisfaction, but contributed to an increased recovery room time. Hypertension and tachycardia were the most complications in group C, and hypotension was the most complication in group I. CONCLUSION: In the average Thai adult population, sedated diagnostic EGD is a good strategy to increase endoscopist satisfaction and willingness to repeat.