Sang Pyo Lee1, In-Kyung Sung1, Jeong Hwan Kim1, Sun-Young Lee1, Hyung Seok Park1, Chan Sup Shim1, Hweung Kon Hwang2, Tae-Yop Kim3, Sang Goon Shim4. 1. Department of Internal Medicine, Digestive Disease Center, Konkuk University School of Medicine, Seoul, Korea. 2. Cardiac and Vascular Center, Konkuk University School of Medicine, Seoul, Korea. 3. Department of Anesthesiology, Konkuk University School of Medicine, Seoul, Korea. 4. Department of Internal Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Korea.
Abstract
OBJECTIVE:Endoscopic submucosal dissection (ESD) is commonly performed as a treatment for gastric neoplasms. However, sedation with midazolam (MDZ) often does not reach satisfactory sedation levels during the procedure and the drug may suppress respiration and blood pressure. This study aimed to investigate the safety and efficacy of dexmedetomidine (DEX) with on-demand MDZ (the DEX group) in comparison with MDZ alone (the MDZ group) as a sedative during ESD of gastric neoplasms. METHODS:Eighty patients undergoing ESD for gastric tumor were randomly assigned to one of two treatment regimens (40 patients in each). We investigated the depth of sedation by using a Modified Observers Assessment Alertness/Sedation score, the number of patients' reactions interfering with the procedure, sedation related-adverse events and the degree of satisfaction of patients and doctors. RESULTS: There was no statistically significant difference between the two groups regarding their age, gender, body mass index, American Society of Anesthesiologists physical status classification and the characteristics of the tumor. Appropriate sedation rate and the degree of satisfaction of the doctors were significantly higher in the DEX group than in the MDZ group. Patients' reactions interfering with the procedure were more numerous in the MDZ group than in the DEX group. There was no significant difference in adverse events between the two groups. CONCLUSIONS:DEX with on-demand MDZ for sedation during gastric ESD is as safe as MDZ alone and the sedation effect of DEX with MDZ is superior to that of MDZ alone.
RCT Entities:
OBJECTIVE: Endoscopic submucosal dissection (ESD) is commonly performed as a treatment for gastric neoplasms. However, sedation with midazolam (MDZ) often does not reach satisfactory sedation levels during the procedure and the drug may suppress respiration and blood pressure. This study aimed to investigate the safety and efficacy of dexmedetomidine (DEX) with on-demand MDZ (the DEX group) in comparison with MDZ alone (the MDZ group) as a sedative during ESD of gastric neoplasms. METHODS: Eighty patients undergoing ESD for gastric tumor were randomly assigned to one of two treatment regimens (40 patients in each). We investigated the depth of sedation by using a Modified Observers Assessment Alertness/Sedation score, the number of patients' reactions interfering with the procedure, sedation related-adverse events and the degree of satisfaction of patients and doctors. RESULTS: There was no statistically significant difference between the two groups regarding their age, gender, body mass index, American Society of Anesthesiologists physical status classification and the characteristics of the tumor. Appropriate sedation rate and the degree of satisfaction of the doctors were significantly higher in the DEX group than in the MDZ group. Patients' reactions interfering with the procedure were more numerous in the MDZ group than in the DEX group. There was no significant difference in adverse events between the two groups. CONCLUSIONS:DEX with on-demand MDZ for sedation during gastric ESD is as safe as MDZ alone and the sedation effect of DEX with MDZ is superior to that of MDZ alone.