Su Jung Han1, Tae Hoon Lee2, Jae Kook Yang1, Young Sin Cho1, Yunho Jung1, Il-Kwun Chung1, Sang-Heum Park1, Suyeon Park3, Sun-Joo Kim1. 1. Division of Gastroenterology, Department of Internal Medicine, Digestive Disease Center, Cheonan Hospital, Soonchunhyang University School of Medicine, 31, Sooncheonhyang 6-gil, Dongnam-gu, Cheonan-si, Chungcheongnam-do, 31151, Republic of Korea. 2. Division of Gastroenterology, Department of Internal Medicine, Digestive Disease Center, Cheonan Hospital, Soonchunhyang University School of Medicine, 31, Sooncheonhyang 6-gil, Dongnam-gu, Cheonan-si, Chungcheongnam-do, 31151, Republic of Korea. thlee9@schmc.ac.kr. 3. Department of Statistics, Soonchunhyang University School of Medicine, Seoul, Republic of Korea.
Abstract
BACKGROUND AND STUDY AIM: Although propofol is widely used for sedation for endoscopic procedures, concerns remain regarding cardiopulmonary adverse events. Etomidate has little effect on the cardiovascular and respiratory systems, but patient satisfaction analysis is lacking. We compared the efficacy and safety of balanced propofol and etomidate sedation during advanced endoscopic procedures. METHODS: As a randomized noninferiority trial, balanced endoscopic sedation was achieved using midazolam and fentanyl, and patients were randomly assigned to receive propofol (BPS) or etomidate (BES) as add-on drug. The main outcomes were sedation efficacy measured on a 10-point visual analog scale (VAS) and safety. RESULTS: In total, 186 patients (94 in the BPS group and 92 in the BES group) were evaluated. BES did not show noninferiority in terms of overall patient satisfaction, with a difference in VAS score of -0.35 (97.5 % confidence interval -1.03 to ∞, p = 0.03). Among endoscopists and nurses, BES showed noninferiority to BPS, with differences in VAS scores of 0.06 and 0.08, respectively. Incidence of cardiopulmonary adverse events was lower in the BES group (27.7 versus 14.1 %, p = 0.023). Hypoxia occurred in 5.3 and 1.1 % of patients in the BPS and BES group (p = 0.211). Myoclonus occurred in 12.1 % (11/92) in the BES group. BES had lower risk of overall cardiopulmonary adverse events (odds ratio 0.401, p = 0.018). CONCLUSIONS:BES was not noninferior to BPS in terms of patient satisfaction. However, BES showed better safety outcomes in terms of cardiopulmonary adverse events.
RCT Entities:
BACKGROUND AND STUDY AIM: Although propofol is widely used for sedation for endoscopic procedures, concerns remain regarding cardiopulmonary adverse events. Etomidate has little effect on the cardiovascular and respiratory systems, but patient satisfaction analysis is lacking. We compared the efficacy and safety of balanced propofol and etomidate sedation during advanced endoscopic procedures. METHODS: As a randomized noninferiority trial, balanced endoscopic sedation was achieved using midazolam and fentanyl, and patients were randomly assigned to receive propofol (BPS) or etomidate (BES) as add-on drug. The main outcomes were sedation efficacy measured on a 10-point visual analog scale (VAS) and safety. RESULTS: In total, 186 patients (94 in the BPS group and 92 in the BES group) were evaluated. BES did not show noninferiority in terms of overall patient satisfaction, with a difference in VAS score of -0.35 (97.5 % confidence interval -1.03 to ∞, p = 0.03). Among endoscopists and nurses, BES showed noninferiority to BPS, with differences in VAS scores of 0.06 and 0.08, respectively. Incidence of cardiopulmonary adverse events was lower in the BES group (27.7 versus 14.1 %, p = 0.023). Hypoxia occurred in 5.3 and 1.1 % of patients in the BPS and BES group (p = 0.211). Myoclonus occurred in 12.1 % (11/92) in the BES group. BES had lower risk of overall cardiopulmonary adverse events (odds ratio 0.401, p = 0.018). CONCLUSIONS:BES was not noninferior to BPS in terms of patient satisfaction. However, BES showed better safety outcomes in terms of cardiopulmonary adverse events.
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