Shao-Hui Chen1, Tang-Mi Yuan1, Jiao Zhang1, Hua Bai2, Ming Tian3, Chu-Xiong Pan4, Hong-Guang Bao5, Xiao-Ju Jin6, Fu-Hai Ji7, Tai-Di Zhong8, Qiang Wang9, Jian-Rui Lv10, Sheng Wang11, Yu-Juan Li12, Yong-Hao Yu13, Ai-Lin Luo14, Xiang-Kui Li15, Su Min16, Lin Li17, Xiao-Hua Zou18, Yu-Guang Huang1. 1. Department of Anesthesiology, Chinese Academy of Medical College and Peking Union Medical College Hospital, Beijing, China. 2. Clinical Pharmacology Research Center, Chinese Academy of Medical College and Peking Union Medical College Hospital, Beijing, China. 3. Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, China. 4. Department of Anesthesiology, Beijing TongRen Hospital, Capital Medical University, Beijing, China. 5. Department of Anesthesiology, Nanjing First Hospital, Nanjing, China. 6. Department of Anesthesiology, Yijishan Hospital of Wannan Medical College, Wuhu, China. 7. Department of Anesthesiology, The First Hospital of Soochow University, Suzhou, China. 8. Department of Anesthesiology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China. 9. Department of Anesthesiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. 10. Department of Anesthesiology, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. 11. Department of Anesthesiology, Guangdong Provincial People's Hospital, Guangzhou, China. 12. Department of Anesthesiology, Sun Yat-Sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China. 13. Department of Anesthesiology, Tianjin Medical University General Hospital, Tianjin, China. 14. Department of Anesthesiology, Tongji Hospital, Wuhan, China. 15. Department of Anesthesiology, Sichuan Provincial People's Hospital, Chengdu, China. 16. Department of Anesthesiology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China. 17. Department of Anesthesiology, The General Hospital of Northern Theater Command, Shenyang, China. 18. Department of Anesthesiology, The Affiliated Hospital of Guizhou Medical University, Guiyang, China.
Abstract
BACKGROUND AND AIM: Remimazolam tosilate (RT) is a new short-acting GABA(A) receptor agonist, having potential to be an effective option for procedural sedation. Here, we aimed to compare the efficacy and safety of RT with propofol in patients undergoing upper gastrointestinal endoscopy. METHODS: This positive-controlled, non-inferiority, phase III trial recruited patients at 17 centers, between September 2017 and November 2017. A total of 384 patients scheduled to undergo upper gastrointestinal endoscopy were randomly assigned to receive RT or propofol. Primary endpoint was the success rate of sedation. Adverse events (AEs) were recorded to evaluate safety. RESULTS: The success rate of sedation in the RT group was non-inferior to that in the propofol group (97.34% vs 100.00%; difference in rate -2.66%, 95% CI -4.96 to -0.36, meeting criteria for non-inferiority). Patients in the RT group had longer time to adequate sedation (P < 0.0001) but shorter time to fully alert (P < 0.0001) than that in the propofol group. The incidences of hypotension (13.04% vs 42.86%, P < 0.0001), treatment-related hypotension (0.54% vs 5.82%, P < 0.0001), and respiratory depression (1.09% vs 6.88%, P = 0.0064) were significantly lower in the RT group. AEs were reported in 74 (39.15%) patients in the RT group and 114 (60.32%) patients in the propofol group, with significant difference (P < 0.0001). CONCLUSION: This trial established non-inferior sedation success rate of RT compared with propofol. RT allows faster recovery from sedation compared with propofol. The safety profile is favorable and appears to be superior to propofol, indicating that it was feasible and well tolerated for patients.
RCT Entities:
BACKGROUND AND AIM: Remimazolam tosilate (RT) is a new short-acting GABA(A) receptor agonist, having potential to be an effective option for procedural sedation. Here, we aimed to compare the efficacy and safety of RT with propofol in patients undergoing upper gastrointestinal endoscopy. METHODS: This positive-controlled, non-inferiority, phase III trial recruited patients at 17 centers, between September 2017 and November 2017. A total of 384 patients scheduled to undergo upper gastrointestinal endoscopy were randomly assigned to receive RT or propofol. Primary endpoint was the success rate of sedation. Adverse events (AEs) were recorded to evaluate safety. RESULTS: The success rate of sedation in the RT group was non-inferior to that in the propofol group (97.34% vs 100.00%; difference in rate -2.66%, 95% CI -4.96 to -0.36, meeting criteria for non-inferiority). Patients in the RT group had longer time to adequate sedation (P < 0.0001) but shorter time to fully alert (P < 0.0001) than that in the propofol group. The incidences of hypotension (13.04% vs 42.86%, P < 0.0001), treatment-related hypotension (0.54% vs 5.82%, P < 0.0001), and respiratory depression (1.09% vs 6.88%, P = 0.0064) were significantly lower in the RT group. AEs were reported in 74 (39.15%) patients in the RT group and 114 (60.32%) patients in the propofol group, with significant difference (P < 0.0001). CONCLUSION: This trial established non-inferior sedation success rate of RT compared with propofol. RT allows faster recovery from sedation compared with propofol. The safety profile is favorable and appears to be superior to propofol, indicating that it was feasible and well tolerated for patients.
Authors: Jae Min Lee; Yehyun Park; Jin Myung Park; Hong Jun Park; Jun Yong Bae; Seung Young Seo; Jee Hyun Lee; Hyung Ku Chon; Jun-Won Chung; Hyun Ho Choi; Jun Kyu Lee; Byung-Wook Kim Journal: Clin Endosc Date: 2022-08-29
Authors: Xianwen Liu; Baofeng Ding; Fu Shi; Yang Zhang; Lei Liu; Yongwei Sha; Tonghang Zhao Journal: Drug Des Devel Ther Date: 2021-11-16 Impact factor: 4.162