Pharmacodynamics study of remimazolam besylate in anxious patients undergoing gastroscopy: a biased-coin design up-and-down sequential allocation trial
Abstract Background This study aimed to evaluate the impact of anxiety on the pharmacodynamics of remimazolam besylate in patients undergoing gastroscopy. Methods Patients undergoing gastroscopy were divided into two groups: an anxiety group (Self -rating Anxiety scale, SAS ≥ 50) and a non-anxiety g...
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2025-07-01
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| Series: | BMC Anesthesiology |
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| Online Access: | https://doi.org/10.1186/s12871-025-03235-3 |
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| author | Bao-Zhu Cha Shuang-Yan Hu Nian-Ping Chen Jia-Fei Cao Cheng Xu Kai Qiu Foquan Luo |
| author_facet | Bao-Zhu Cha Shuang-Yan Hu Nian-Ping Chen Jia-Fei Cao Cheng Xu Kai Qiu Foquan Luo |
| author_sort | Bao-Zhu Cha |
| collection | DOAJ |
| description | Abstract Background This study aimed to evaluate the impact of anxiety on the pharmacodynamics of remimazolam besylate in patients undergoing gastroscopy. Methods Patients undergoing gastroscopy were divided into two groups: an anxiety group (Self -rating Anxiety scale, SAS ≥ 50) and a non-anxiety group (SAS < 50). All patients received intravenous administration of 5 µg/kg alfentanil combined with remimazolam besylate. The biased coin design up-and-down sequential method (BCD-UDM) was used to determine the target doses of remimazolam besylate: the initial dose was 0.1 mg/kg, with a dose gradient of 0.01 mg/kg. If coughing, swallowing, or body movement reactions occurred within the first 2 min from the start of gastroscopy, it was considered a positive reaction, and the dose was increased for the next patient. Otherwise, it was considered a negative reaction, and the dose of remimazolam besylate for the next patient was determined according to the BCD-UDM. Discharge time from the recovery room and adverse reactions were recorded. The ED50, ED90, and their 95% confidence intervals (CI) were calculated. Results The ED50 and ED90 of remimazolam besylate in the anxiety group were 0.175 mg/kg (95% CI, 0.140–0.240) and 0.251 mg/kg (95% CI, 0.173–0.250), respectively. In contrast, the ED50 and ED90 of remimazolam besylate in the non-anxiety group were 0.126 mg/kg (95% CI, 0.116–0.150) and 0.148 mg/kg (95% CI, 0.130–0.160), respectively. The ED90 equivalent ratio of the non-anxiety group to the anxiety group was 0.59 (95% CI, 0.468–0.710). The discharge time from the recovery room and the incidence of adverse reactions did not differ significantly between the groups. Conclusions When combined with 5 µg/kg alfentanil, the ED50 and ED90 of remimazolam besylate for inhibiting body movement response within two minutes of gastroscopy in anxious patients were 0.175 mg/kg and 0.251 mg/kg, respectively. Anxiety increased the requirement for remimazolam besylate in patients undergoing gastroscopy, but it did not increase the risk of prolonged discharge time or adverse effects. Trial registration The study was registered in the Chinese Clinical Trial Registry. (ChiCTR2400086957) on July 15, 2024. |
| format | Article |
| id | doaj-art-d07482729ca745dfa145cb10433d1337 |
| institution | Kabale University |
| issn | 1471-2253 |
| language | English |
| publishDate | 2025-07-01 |
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| spelling | doaj-art-d07482729ca745dfa145cb10433d13372025-08-20T03:46:19ZengBMCBMC Anesthesiology1471-22532025-07-012511910.1186/s12871-025-03235-3Pharmacodynamics study of remimazolam besylate in anxious patients undergoing gastroscopy: a biased-coin design up-and-down sequential allocation trialBao-Zhu Cha0Shuang-Yan Hu1Nian-Ping Chen2Jia-Fei Cao3Cheng Xu4Kai Qiu5Foquan Luo6Department of Anesthesiology, Affiliated Hospital of Shaoxing UniversityDepartment of Anesthesiology, Shaoxing People’s HospitalDepartment of Anesthesiology, Affiliated Hospital of Shaoxing UniversityDepartment of Anesthesiology, Affiliated Hospital of Shaoxing UniversityDepartment of Anesthesiology, Shaoxing People’s HospitalDepartment of Anesthesiology, Shaoxing People’s HospitalDepartment of Anesthesiology, Zhejiang Provincial People’s Hospital, Affiliated People’s Hospital, Hangzhou medical collegeAbstract Background This study aimed to evaluate the impact of anxiety on the pharmacodynamics of remimazolam besylate in patients undergoing gastroscopy. Methods Patients undergoing gastroscopy were divided into two groups: an anxiety group (Self -rating Anxiety scale, SAS ≥ 50) and a non-anxiety group (SAS < 50). All patients received intravenous administration of 5 µg/kg alfentanil combined with remimazolam besylate. The biased coin design up-and-down sequential method (BCD-UDM) was used to determine the target doses of remimazolam besylate: the initial dose was 0.1 mg/kg, with a dose gradient of 0.01 mg/kg. If coughing, swallowing, or body movement reactions occurred within the first 2 min from the start of gastroscopy, it was considered a positive reaction, and the dose was increased for the next patient. Otherwise, it was considered a negative reaction, and the dose of remimazolam besylate for the next patient was determined according to the BCD-UDM. Discharge time from the recovery room and adverse reactions were recorded. The ED50, ED90, and their 95% confidence intervals (CI) were calculated. Results The ED50 and ED90 of remimazolam besylate in the anxiety group were 0.175 mg/kg (95% CI, 0.140–0.240) and 0.251 mg/kg (95% CI, 0.173–0.250), respectively. In contrast, the ED50 and ED90 of remimazolam besylate in the non-anxiety group were 0.126 mg/kg (95% CI, 0.116–0.150) and 0.148 mg/kg (95% CI, 0.130–0.160), respectively. The ED90 equivalent ratio of the non-anxiety group to the anxiety group was 0.59 (95% CI, 0.468–0.710). The discharge time from the recovery room and the incidence of adverse reactions did not differ significantly between the groups. Conclusions When combined with 5 µg/kg alfentanil, the ED50 and ED90 of remimazolam besylate for inhibiting body movement response within two minutes of gastroscopy in anxious patients were 0.175 mg/kg and 0.251 mg/kg, respectively. Anxiety increased the requirement for remimazolam besylate in patients undergoing gastroscopy, but it did not increase the risk of prolonged discharge time or adverse effects. Trial registration The study was registered in the Chinese Clinical Trial Registry. (ChiCTR2400086957) on July 15, 2024.https://doi.org/10.1186/s12871-025-03235-3AnxietyRemimazolam besylateAlfentanilGastroscope |
| spellingShingle | Bao-Zhu Cha Shuang-Yan Hu Nian-Ping Chen Jia-Fei Cao Cheng Xu Kai Qiu Foquan Luo Pharmacodynamics study of remimazolam besylate in anxious patients undergoing gastroscopy: a biased-coin design up-and-down sequential allocation trial BMC Anesthesiology Anxiety Remimazolam besylate Alfentanil Gastroscope |
| title | Pharmacodynamics study of remimazolam besylate in anxious patients undergoing gastroscopy: a biased-coin design up-and-down sequential allocation trial |
| title_full | Pharmacodynamics study of remimazolam besylate in anxious patients undergoing gastroscopy: a biased-coin design up-and-down sequential allocation trial |
| title_fullStr | Pharmacodynamics study of remimazolam besylate in anxious patients undergoing gastroscopy: a biased-coin design up-and-down sequential allocation trial |
| title_full_unstemmed | Pharmacodynamics study of remimazolam besylate in anxious patients undergoing gastroscopy: a biased-coin design up-and-down sequential allocation trial |
| title_short | Pharmacodynamics study of remimazolam besylate in anxious patients undergoing gastroscopy: a biased-coin design up-and-down sequential allocation trial |
| title_sort | pharmacodynamics study of remimazolam besylate in anxious patients undergoing gastroscopy a biased coin design up and down sequential allocation trial |
| topic | Anxiety Remimazolam besylate Alfentanil Gastroscope |
| url | https://doi.org/10.1186/s12871-025-03235-3 |
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