95% effective dose of remimazolam in brachial plexus block assistedsedation and its efficacy and safety
Objective To investigate the 95% effective dose（ED95）of remimazolam for brachial plexus block（BPB）-assisted sedation and its effectiveness and safety, and to compare it with propofol. Methods Two-part clinical trials were conducted in patients undergoing elective BPB for upper limb surgery from Dece...
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| Format: | Article |
| Language: | zho |
| Published: |
The Editorial Department of Chinese Journal of Clinical Research
2025-06-01
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| Series: | Zhongguo linchuang yanjiu |
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| Online Access: | http://zglcyj.ijournals.cn/zglcyj/ch/reader/create_pdf.aspx?file_no=20250610 |
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| Summary: | Objective To investigate the 95% effective dose（ED95）of remimazolam for brachial plexus block（BPB）-assisted sedation and its effectiveness and safety, and to compare it with propofol. Methods Two-part clinical trials were conducted in patients undergoing elective BPB for upper limb surgery from December 2023 to May 2024 at Jingzhou Hospital Affiliated to Yangtze University. In the first part, using the biased coin up ⁃ and ⁃ down sequential allocation method to study the ED95 of remimazolam and propofol for BPB assisted sedation, 100 patients were randomly divided into remimazolam group（R1 group）and propofol group（B1 group）, with 50 cases in each group. Sedative adjuvant medication：the R1 group received a loading dose of 0.1 mg/kg and an initial maintenance dose of 0.1 mg·kg-1·h-1, with a dose gradient of 0.02 mg·kg-1·h-1. The B1 group received a loading dose of 1 mg/kg and an initial maintenance dose of3 mg·kg-1·h-1, with a dose gradient of 0.2 mg·kg-1·h-1. Probit probabilistic regression was used to calculate the ED95 and patients were randomly divided into remimazolam group（R2 group）and propofol group（B2 group）, with 31 cases ineach group. Sedative adjuvant medication：the loading dose was 0.1 mg/kg in the R2 group and 1 mg/kg in the B2group, and then both groups were pumped with ED95 dose until suturing. The mean arterial pressure（MAP）, heart rate（HR）, pulse oxygen saturation（SpO2）and modified observer’s assessment of alertness/sedation（MOAA/S）score were recorded at each time point［before administration（T0）, completion of loading（T1）, 10, 15, 30 min after administration （T2, T3, T4）, drug withdrawal（T5）, the end of surgery（T6）］, and the incidence of hypotension, blood pressure variability（BPV）of MAP, waking time and adverse reactions were recorded in the two groups.Results The ED95 values for remimazolam and propofol were 0.310 mg·kg-1·h-1（95% CI：0.281⁃0.486 mg·kg-1·h-1）and 5.564 mg·kg-1·h-1（95% CI：5.101⁃10.478 mg·kg-1·h-1）, respectively. Compared with B2 group, R2 group had higher MAP and HR during sedation, earlier awake time, lower BPV value, lower incidence of hypotension, hypoxemiaand injection pain, with statistical significances（P<0.05）. The MOAA/S score of R2 group was higher than that of B2group only at T5（P<0.05）. Conclusion The ED95 for remimazolam in BPB-assisted sedation is 0.310 mg·kg- 1·h- 1.Compared to the same dose of propofol, remimazolam has obvious sedative effect, little influence on vital signs and fewer adverse reactions. |
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| ISSN: | 1674-8182 |