دورية أكاديمية
Effects of ciprofol for the induction of general anesthesia in patients scheduled for elective surgery compared to propofol: a phase 3, multicenter, randomized, double-blind, comparative study.
| العنوان: | Effects of ciprofol for the induction of general anesthesia in patients scheduled for elective surgery compared to propofol: a phase 3, multicenter, randomized, double-blind, comparative study. |
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| المؤلفون: | Wang X; Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China. zuoyunxia@scu.edu.cn., Wang X, Liu J, Zuo YX, Zhu QM, Wei XC, Zou XH, Luo AL, Zhang FX, Li YL, Zheng H, Li H, Wang S, Wang DX, Guo QL, Liu CM, Wang YT, Zhu ZQ, Wang GY, Ai YQ, Xu MJ |
| المصدر: | European review for medical and pharmacological sciences [Eur Rev Med Pharmacol Sci] 2022 Mar; Vol. 26 (5), pp. 1607-1617. |
| نوع المنشور: | Journal Article; Multicenter Study; Randomized Controlled Trial |
| اللغة: | English |
| بيانات الدورية: | Publisher: Verduci Country of Publication: Italy NLM ID: 9717360 Publication Model: Print Cited Medium: Internet ISSN: 2284-0729 (Electronic) Linking ISSN: 11283602 NLM ISO Abbreviation: Eur Rev Med Pharmacol Sci Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Rome : Verduci, [1997- |
| مواضيع طبية MeSH: | Propofol*/pharmacology, Anesthesia, General ; Anesthetics, Intravenous ; Double-Blind Method ; Elective Surgical Procedures ; Humans ; Hypnotics and Sedatives |
| مستخلص: | Objective: Ciprofol is a newly developed intravenous sedative-hypnotic drug. The objective of the study was to prove whether ciprofol was non-inferior to propofol for the successful induction of general anesthesia. The ideal post-induction sedation level was assessed by comparing patients' clinical symptoms and their hemodynamic effects in responding to noxious stimuli, mostly tracheal intubation and bispectral index (BIS) alterations following ciprofol/propofol administration. Patients and Methods: In this multi-center, randomized, double-blind phase 3 trial, selective surgery patients were randomly assigned in a 1:1 ratio to either ciprofol 0.4 mg/kg (n = 88) or propofol 2.0 mg/kg (n = 88) groups. The primary endpoint was the percentage of patients with successful anesthesia inductions. Secondary endpoints included the times to successful induction of general anesthesia and loss of the eyelash reflex, changes in BIS, as well as safety indicators. Results: The anesthesia induction success rates for both ciprofol 0.4 mg/kg and propofol 2 mg/kg groups were 100.0%, with a 95% CI lower success limit of -4.18% difference between the two groups, indicating that ciprofol was non-inferior to propofol. For secondary outcomes, the average time to successful anesthesia and loss of the eyelash reflex were 0.91 min and 0.80 min for ciprofol and 0.80 min and 0.71 min for propofol, respectively. The pattern of BIS changes with ciprofol was similar to propofol and stable during the anesthesia maintenance period. Safety was comparable with 88.6% TEAEs in the ciprofol group compared to 95.5% in the propofol group. The incidence of injection pain was significantly lower in the ciprofol group compared to the propofol group (6.8% vs. 20.5%, p < 0.05). In addition, the patients treated with ciprofol had a lesser increase in blood pressure and heart rate, and fewer cases with BIS > 60 within 15 min of intravenous administration, which indicated that ciprofol may provide a better ideal sedation level during the post-induction period under an equivalent dosing regimen to propofol. Conclusions: Ciprofol for patients undergoing selective surgery is a new option for the induction of general anesthesia. |
| المشرفين على المادة: | 0 (Anesthetics, Intravenous) 0 (Hypnotics and Sedatives) YI7VU623SF (Propofol) |
| تواريخ الأحداث: | Date Created: 20220318 Date Completed: 20220422 Latest Revision: 20220422 |
| رمز التحديث: | 20240628 |
| DOI: | 10.26355/eurrev_202203_28228 |
| PMID: | 35302207 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 2284-0729 |
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| DOI: | 10.26355/eurrev_202203_28228 |