Abstract
BACKGROUND This prospective, randomized, controlled study evaluated the efficacy and safety of remimazolam tosilate sedation with adjuvant sufentanil, relative to propofol, for Chinese patients with liver cirrhosis undergoing gastroscopy. MATERIAL AND METHODS Patients with liver cirrhosis (n=148) aged 18-65 years and undergoing gastroscopy were randomly and equally allocated to receive either 0.107 mg/kg remimazolam tosilate (remimazolam group) or 2 mg/kg propofol. Patients received intravenous sufentanil 0.15 μg/kg before the study drug. If necessary, an additional dose of propofol 20 mg was used and repeated. The primary outcome was the satisfaction rating (satisfactory, fair, or unsatisfactory) of the endoscopist with the sedation. Secondary outcomes were complications (respiratory depression, apnea, body movement, bradycardia, hypotension, nausea or vomiting, somnolence, dizziness, and fever) and patient satisfaction. RESULTS Compared with the propofol group, the remimazolam group required a longer time to sedation and a shorter time to emergence. The percentage of remimazolam sedations the endoscopist rated satisfactory (90.5%) was higher than that for propofol (77.0%; P=0.026). Patients given remimazolam experienced lower rates of respiratory depression, body movement, and hypotension (2.7, 8.1, 4.1%, respectively), than did the propofol group (17.6, 23.0, 14.9%; P=0.003, 0.013, 0.025). The 2 groups were comparable regarding the other secondary outcomes. CONCLUSIONS For Chinese patients with liver cirrhosis undergoing gastroscopy, remimazolam tosilate with adjuvant sufentanil provides a satisfactory level of sedation with a good safety profile.