Drug Design, Development and Therapy (Dec 2022)
Effect of Remimazolam Tosilate on Respiratory Depression in Elderly Patients Undergoing Gastroscopy: A Multicentered, Prospective, and Randomized Study
Abstract
Bailong Hu,1,2,* Ke Jiang,1,* Wenyan Shi,3 Shixiang Xiao,4 Shili Zhang,5 Yongguo Zhang,6 Yuancheng Zhou,7 Chengwei Tan,8 Songjiang Tan,9 Xiaohua Zou1,2 1Department of Anesthesiology, The Affiliated Hospital of Guizhou Medical University, Guiyang, People’s Republic of China; 2College of Anesthesiology, Guizhou Medical University, Guiyang, People’s Republic of China; 3Department of Anesthesiology, The Second Affiliated Hospital of Zunyi Medical University, Zunyi, People’s Republic of China; 4Department of Anesthesiology, The First People’ s Hospital of Bijie City, Bijie, People’s Republic of China; 5Department of Anesthesiology, Dali Bai Autonomous Prefecture People’s Hospital, Dali, People’s Republic of China; 6Department of Anesthesiology, The People’s Hospital of Qiannan, Qiannan, People’s Republic of China; 7Department of Anesthesiology, The First People’s Hospital of Guiyang, Guiyang, People’s Republic of China; 8Department of Anesthesiology, The Second People’s Hospital of Guiyang, Guiyang, People’s Republic of China; 9Department of Anesthesiology, The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, Guiyang, People’s Republic of China*These authors contributed equally to this workCorrespondence: Xiaohua Zou; Songjiang Tan, Fax +86-851-86771013, Email [email protected]; [email protected]: Remimazolam tosilate (RT) is a new type of γ-aminobutyric acid subtype A (GABAA) receptor agonist, having the possibility to be an ideal sedative drug for procedural sedation. At present, there are few studies on the effect of RT on respiratory depression in elderly patients. We aimed to evaluate the effect of RT on respiratory depression in elderly patients undergoing gastroscopy.Methods: This prospective, randomized, single-blinded trial recruited patients from eight centers in China between May 2022 and July 2022. A total of 346 elderly patients undergoing gastroscopy were randomly divided into RT group (0.2 mg/kg) or propofol group (1.5 mg/kg), respectively. The primary outcome was the incidence of respiratory depression. Secondary outcomes include the incidence of sedative-related adverse events, the success rate of sedation, time to fully alert, time to loss of consciousness (LOC), time to ready for discharge, as well as the the patients, endoscopists and anethetists’ satisfaction.Results: The incidence of respiratory depression was significantly reduced in the RT group compared with the propofol group (9.8% vs 17.9%, P=0.042). The time of LOC and fully alert in the RT group were longer than that in the propofol group (P < 0.05). The incidences of hypotention (50.9% vs 32.4%, P=0.001) and hypotension requiring treatment (5.8% vs 1.7%, P=0.031) were significantly higher in the propofol group than that in the RT group. The incidence and severity of injection pain were more frequently recorded in the propofol group than that in the RT group (40.5% vs 12.1%, P< 0.05). There were no statistically significant differences between the two groups in terms of sedation success rates, time to ready for discharge, endoscopists and anethetists’ satisfaction and other sedative-related adverse events.Conclusion: RT may be a suitable alternative sedative agent for elderly patients undergoing gastroscopy due to its safety profile.Keywords: Remimazolam tosilate, propofol, elderly patients, gastroscopy
