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Войти в исследования Drug design, development and therapy · 2026
Effects of Ciprofol Combined with Varying Doses of Alfentanil on Anesthetic Efficacy and Safety in Pediatric Bronchoscopy: A Randomized Controlled Trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Yang Qiao, He Weihua, Li Fan, Bi Shenglong, Jiang Qiong
Аннотация
OBJECTIVE: This study aims to evaluate the anesthetic safety of the ciprofol and alfentanil regimen for pediatric bronchoscopy and to determine the effective concentration of alfentanil.
METHODS: In this single-center, prospective, double-blind, randomized controlled trial, pediatric patients scheduled for fiberoptic bronchoscopy were randomly divided into three groups: ciprofol combined with 5 μg/kg alfentanil group (Group A), ciprofol combined with 10 μg/kg alfentanil group (Group B) and ciprofol-only group (Group C). Firstly, the anesthesia nurse intravenously administered analgesic medication: 5 μg/kg alfentanil, 10 μg/kg alfentanil or 2 mL of normal saline intravenously. And then administered 0.4 mg/kg of ciprofol. After induction, supplemental ciprofol (0.1 mg/kg) was given as needed according to cough score and vital signs. The primary outcome was the coughing score during bronchoscope passage through the glottis (T3) and carina (T4). Secondary outcomes included anesthesia induction cooperation scores, intraoperative anesthesia effect ratings, operator satisfaction levels, occurrence of adverse reactions, as well as hemodynamics and oxygen saturation at T1-T5.
RESULTS: Between February 2025 and October 2025, 97 patients were included (Group A: n=32, Group B: n=33, Group C: n=32). Group B has better anesthesia quality, as assessed by several measures. For example, Compared with the ciprofol-only group, Group B exhibited lower cough scores during passage through the glottis and carina (median (IQR): T3, 2 (1.5-2) vs. 2.5 (2-4), p = 0.015; T4, 2 (1-2) vs. 2 (2-3), p = 0.02). Additionally, this group significantly improved operator satisfaction (p = 0.04), and higher rates of excellent or good anesthesia outcomes (p = 0.026). Finally, there was no significant difference in adverse reactions and safety indicators among the three groups (p > 0.05).
CONCLUSION: The combination of ciprofol with 10 µg/kg alfentanil may be more appropriate for clinical anesthesia during pediatric bronchoscopy without increasing the incidence of side effects.
TRIAL REGISTRATION: ChiCTR.org.cn (ChiCTR2500097084). Date of registration: February 12, 2025.
METHODS: In this single-center, prospective, double-blind, randomized controlled trial, pediatric patients scheduled for fiberoptic bronchoscopy were randomly divided into three groups: ciprofol combined with 5 μg/kg alfentanil group (Group A), ciprofol combined with 10 μg/kg alfentanil group (Group B) and ciprofol-only group (Group C). Firstly, the anesthesia nurse intravenously administered analgesic medication: 5 μg/kg alfentanil, 10 μg/kg alfentanil or 2 mL of normal saline intravenously. And then administered 0.4 mg/kg of ciprofol. After induction, supplemental ciprofol (0.1 mg/kg) was given as needed according to cough score and vital signs. The primary outcome was the coughing score during bronchoscope passage through the glottis (T3) and carina (T4). Secondary outcomes included anesthesia induction cooperation scores, intraoperative anesthesia effect ratings, operator satisfaction levels, occurrence of adverse reactions, as well as hemodynamics and oxygen saturation at T1-T5.
RESULTS: Between February 2025 and October 2025, 97 patients were included (Group A: n=32, Group B: n=33, Group C: n=32). Group B has better anesthesia quality, as assessed by several measures. For example, Compared with the ciprofol-only group, Group B exhibited lower cough scores during passage through the glottis and carina (median (IQR): T3, 2 (1.5-2) vs. 2.5 (2-4), p = 0.015; T4, 2 (1-2) vs. 2 (2-3), p = 0.02). Additionally, this group significantly improved operator satisfaction (p = 0.04), and higher rates of excellent or good anesthesia outcomes (p = 0.026). Finally, there was no significant difference in adverse reactions and safety indicators among the three groups (p > 0.05).
CONCLUSION: The combination of ciprofol with 10 µg/kg alfentanil may be more appropriate for clinical anesthesia during pediatric bronchoscopy without increasing the incidence of side effects.
TRIAL REGISTRATION: ChiCTR.org.cn (ChiCTR2500097084). Date of registration: February 12, 2025.