Determination of ED50 and ED95 of remimazolam besylate combined with alfentanil for adult gastroscopy: a prospective dose-finding study
Determinação de ED50 e ED95 de besilato de remimazolam combinado com alfentanil para gastroscopia em adultos: um estudo prospectivo para determinação de dose
Pingjuan Wang, Song Xue, Liufei Zhang, Kunkun Gao, Yiqiao Wang
Abstract
Background
To explore the median effective dose (ED50) and 95% effective dose (ED95) of remimazolam besylate combined with alfentanil for adult gastroscopy.
Methods
This prospective studyenrolled 31 patients scheduled to painless gastroscopy at Anhui No. 2 Provincial People's Hospital between April and May, 2022. 5 µg.kg−1 of alfentanil hydrochloride was used for pre-analgesia. The initial single loading dose of remimazolam besylate was 0.12 mg.kg−1, increased or reduced by 0.01 mg.kg−1 for the next patient with modified Dixon sequential method. The modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S) was used to assess sedation.
Results
Combined with alfentanil, the ED50 of remimazolam besylate was 0.147 mg.kg−1 (95% CI: 0.138-0.160 mg.kg−1) and ED95 0.171 mg.kg−1 (95% CI: 0.159-0.245 mg.kg−1). The induction time after injection of remimazolam besylate was 70 ± 25 s, with the anesthesia recovery time and the observation time in resuscitation room 5.13 ± 2.13 min and 2.32 ± 1.6 min, respectively.29 patients’ vital signs were within acceptable limits during gastroscopy.
Conclusions
The ED50 of remimazolam besylate combined with alfentanil for painless gastroscopy was 0.147 mg.kg−1, and the ED95 was 0.171 mg.kg−1.
Keywords
Resumo
Introdução
Explorar a dose eficaz mediana (ED50) e a dose eficaz de 95% (ED95) de besilato de remimazolam combinado com alfentanil para gastroscopia de adultos.
Métodos
Este estudo prospectivo envolveu 31 pacientes agendados para gastroscopia indolor no Hospital Popular Provincial nº 2 de Anhui entre abril e maio de 2022. 5 µg.kg−1 de cloridrato de alfentanil foram usados para pré-analgesia. A dose de ataque única inicial de besilato de remimazolam foi de 0,12 mg.kg−1, aumentada ou reduzida em 0,01 mg.kg−1 para o próximo paciente com método sequencial de Dixon modificado. A Escala de Avaliação de Prontidão/Sedação do Observador modificada (MOAA/S) foi utilizada para avaliar a sedação.
Resultados
Combinado com alfentanil, a DE50 do besilato de remimazolam foi de 0,147 mg.kg-1 (IC 95%: 0,138-0,160 mg.kg-1) e a DE95 de 0,171 mg.kg-1 (IC 95%: 0,159-0,245 mg.kg-1). 1). O tempo de indução após a injeção do besilato de remimazolam foi de 70 ± 25 s, sendo o tempo de recuperação da anestesia e o tempo de observação na sala de reanimação de 5,13 ± 2,13 min e 2,32 ± 1,6 min, respectivamente. Os sinais vitais de vinte e nove pacientes estavam dentro dos limites aceitáveis durante a gastroscopia.
Conclusão
A DE50 do besilato de remimazolam combinado com alfentanil para gastroscopia indolor foi de 0,147 mg.kg-1, e a DE95 foi de 0,171 mg.kg-1.
Palavras-chave
Referencias
1. Watanabe T, Miyoshi H, Noda Y, et al. Effects of Remimazolam and Propofol on Ca (2+) Regulation by Ryanodine Receptor 1 with Malignant Hyperthermia Mutation. Biomed Res Int. 2021; 2021:8845129.
2. Zhang X, Li S, Liu J. Efficacy and safety of remimazolam besylate versus propofol during hysteroscopy: single-centre randomized controlled trial. BMC Anesthesiol. 2021;21:156.
3. Borkett KM, Riff DS, Schwartz HI, et al. A Phase IIa, randomized, double-blind study of remimazolam (CNS 7056) versus midazolam for sedation in upper gastrointestinal endoscopy. Anesth Analg. 2015;120:771−80.
4. Xiao X, Xiao N, Zeng F, et al. Gastroscopy sedation: clinical trial comparing propofol and sufentanil with or without remimazolam. Minerva Anestesiol. 2022;88:223−9.
5. Sabourdin N, Diarra C, Wolk R, et al. Pupillary Pain Index Changes After a Standardized Bolus of Alfentanil Under Sevoflurane Anesthesia: First Evaluation of a New Pupillometric Index to Assess the Level of Analgesia During General Anesthesia. Anesth Analg. 2019;128:467−74.
6. Chen X, Xin D, Xu G, et al. The Efficacy and Safety of Remimazolam Tosilate Versus Dexmedetomidine in Outpatients Undergoing Flexible Bronchoscopy: A Prospective, Randomized, Blind, Non-Inferiority Trial. Front Pharmacol. 2022;13:902065.
7. Lichtenstein DR, Jagannath S, Baron TH, et al. Sedation and anesthesia in GI endoscopy. Gastrointest Endosc. 2008; 68:815−26.
8. Soma Y, Saito H, Kishibe T, et al. Evaluation of topical pharyngeal anesthesia for upper endoscopy including factors associated with patient tolerance. Gastrointest Endosc. 2001; 53:14−8.
9. Besylate Remimazolam. Am J Health Syst Pharm. 2021;78:935−8.
10. Cao Y, Chi P, Zhou C, et al. Remimazolam Tosilate Sedation with Adjuvant Sufentanil in Chinese Patients with Liver Cirrhosis Undergoing Gastroscopy: A Randomized Controlled Study. Med Sci Monit. 2022;28:e936580.
Submitted date:
24/08/2023
Accepted date:
14/05/2024
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