Background Remimazolam tosilate (RT) is a newly listed benzodiazepine for sedation and anesthesia featuring quick onset of effects, short maintenance and recovery times, which is currently under research. This trial was conducted to determine the median effective dose (ED50) and the 95% effective dose (ED95) of single-dose remimazolam for moderate sedation in elderly patients undergoing transurethral resection of the prostate (TURP) under spinal anesthesia, and to evaluate its efficacy and safety. Methods Thirty male patients aged 65–80 years old were recruited for selective TURP. Remimazolam was administered intravenously to pain-free patients (VAS score < 1) within 1 min of successful spinal anesthesia by the same anesthesiologist. We used modified Dixon’s up-and-down sequential allocation method to determine the ED50 and ED95 of the agent with an initial dosage of 0.1 mg/kg. Successful sedation was defined as an MOAA/S score ≤ 3 and above 1. A score of > 3 was deemed as failed sedation. Recruitment continued until ten independent pairs (from successful sedation to failed sedation) would give a reliable estimation of the ED50 and ED95 of RT and their 95% confidence intervals. Results The ED50 of remimazolam was 0.063 (95% C.I. 0.045–0.073) mg/kg. Its ED95 was 0.079 (95% C.I. 0.07–0.137) mg/kg. Remimazolam was safe in its application. Conclusions A single-dose of RT proves to be safe for assisted sedation during TURP in elderly male patients under spinal anesthesia with a lower incidence of adverse events. Its ED50 and ED95 were 0.063 mg/kg and 0.079 mg/kg, respectively. Trial registration http://www.chictr.org.cn (ChiCTR2100051912).

Background The Bispectral Index (BIS) and the Patient State Index (PSI) are commonly used measures to assess intraoperative sedation depth. However, model differences lead to different results, which in turn interferes with clinicians’ judgment on the depth of anesthesia. Remimazolam tosilate (RT) for injection is a new benzodiazepine used in sedation. In its clinical application, there are few effective indicators for sedation depth monitoring. To close this gap, this study aims to compare BIS and PSI in measuring the sensitivity and specificity of intraoperative RT and to explore the safety of RT for intraspinal anesthesia in elderly patients. Methods This study included 40 patients undergoing elective electro-prostatectomy with intraspinal anesthesia, who were monitored by BIS and PSI simultaneously during operation. Remimazolam tosylate 0.1 mg/kg was intravenously administered after the intraspinal anesthesia when patients were in a completely painless status. Then BIS, PSI, the Modified Observer’s Assessment of Alertness and Sedation (MOAA/S) scores and vital signs were observed and recorded per minute for 10 min. Pearson’s correlation analysis and linear regression model were used to compare BIS and PSI sedation scores, and to test their associations with the MOAA/S score, respectively. ROC curves were drawn to compare the sensitivity and specificity of BIS and PSI. Changes of vital signs were presented as mean ± standard deviation. Perioperative liver and kidney function indicators were analyzed using a paired t-test to evaluate the safety of RT for intraspinal anesthesia in the elderly patients. Results According to Pearson’s correlation analysis, a significant (P < 0.01) correlation between BIS and PSI was found when used to monitor intraoperative sedation of RT (r = 0.796). Significant associations between BIS and MOAA/S (r = 0.568, P < 0.01), and between PSI and MOAA/S (r = 0.390, P < 0.01) were also found. The areas under the ROC curves of BIS and PSI were 0.801 ± 0.022 and 0.734 ± 0.026, respectively, suggesting that both measures may predict patients’ state of consciousness and BIS was more accurate than PSI. Vital signs remained stable throughout the study. No abnormal changes of clinical significance were found based on laboratory test results of liver and kidney function. Conclusion BIS and PSI are strongly associated for monitoring the sedation of RT intraoperatively. Both methods can accurately reflect sedation depth. According to correlation analyses with MOAA/S scale and ROC curves, BIS is more accurate than PSI during such intraoperative monitoring. In addition, RT can be safely used in elderly patients under intraspinal anesthesia for supportive sedation, with stable vital signs and sound kidney and liver safety profiles. Trial registration http://www.chictr.org.cn (ChiCTR2100051912).

Background Remimazolam tosilate (RT) is a newly listed benzodiazepine for sedation and anesthesia featuring quick onset of effects, short maintenance and recovery times, which is currently under research. This trial was conducted to determine the median effective dose (ED50) and the 95% effective dose (ED95) of single-dose remimazolam for moderate sedation in elderly patients undergoing transurethral resection of the prostate (TURP) under spinal anesthesia, and to evaluate its efficacy and safety. Methods Thirty male patients aged 65–80 years old were recruited for selective TURP. Remimazolam was administered intravenously to pain-free patients (VAS score < 1) within 1 min of successful spinal anesthesia by the same anesthesiologist. We used modified Dixon’s up-and-down sequential allocation method to determine the ED50 and ED95 of the agent with an initial dosage of 0.1 mg/kg. Successful sedation was defined as an MOAA/S score ≤ 3 and above 1. A score of > 3 was deemed as failed sedation. Recruitment continued until ten independent pairs (from successful sedation to failed sedation) would give a reliable estimation of the ED50 and ED95 of RT and their 95% confidence intervals. Results The ED50 of remimazolam was 0.063 (95% C.I. 0.045–0.073) mg/kg. Its ED95 was 0.079 (95% C.I. 0.07–0.137) mg/kg. Remimazolam was safe in its application. Conclusions A single-dose of RT proves to be safe for assisted sedation during TURP in elderly male patients under spinal anesthesia with a lower incidence of adverse events. Its ED50 and ED95 were 0.063 mg/kg and 0.079 mg/kg, respectively. Trial registration: http://www.chictr.org.cn (ChiCTR2100051912)