Liao Min, Wu Xiao-Ru, Hu Jia-Ning, Lin Xing-Zhou, Zhao Tang-Yuan-Meng, Sun Hu
The Second Affiliated Hospital of Hainan Medical University, Hai Kou, China.
West China Hospital, Sichuan University, Chengdu, 610041, China.
Sci Rep. 2025 Jan 13;15(1):1822. doi: 10.1038/s41598-025-85968-2.
Ciprofol, a novel γ-aminobutyric acid receptor agonist, outperforms propofol with minimal cardiovascular effects, higher potency, reduced injection pain, and a broader safety margin. Despite these advantages, ciprofol's clinical research is still emerging. This study compares the median effective dose (ED) and adverse reactions of ciprofol and propofol, in conjunction with sufentanil, for suppressing cardiovascular responses during tracheal intubation. Fifty-three adult patients scheduled for tracheal intubation under general anesthesia were enrolled and randomly assigned to receive either ciprofol (Group C) or propofol (Group P), according to a random number table. Tracheal intubation was performed using a standardized laryngoscope and endotracheal tube. The Dixon's up-and-down method was employed to determine the ED and 95% effective dose (ED) of ciprofol and propofol in inhibiting cardiovascular responses during tracheal intubation. Based on the pilot study, the initial dose for ciprofol was set at 0.35 mg/kg (with a 0.01 mg/kg increment) and for propofol at 2.0 mg/kg (with a 0.1 mg/kg increment). Probit analysis was applied to derive dose-response curves, while adverse reactions were continuously monitored. A total of 54 participants were included, with 24 in group C (1 excluded) and 30 in group P. Probit analysis revealed that the ED of ciprofol for inhibiting cardiovascular responses to tracheal intubation were 0.326 mg/kg (95% CI 0.304-0.337 mg/kg), and for propofol, 1.541 mg/kg (95% CI 1.481-1.599 mg/kg). The heart rate in group P was significantly higher than the group C at 1 minute (p = 0.026) and 3 minutes (p = 0.016) post-intubation. Systolic and diastolic blood pressures (SBP and DBP) decreased significantly before and after intubation compared to baseline values in both groups (p< 0.05). Group C experienced significantly less injection pain (p = 0.001), although the incidence of other adverse effects was not statistically different between groups (p > 0.05).Clinical Trial Registration: hppts://ClinicalTrials.gov; Identifier: NCT06095570(18/10/2023).
环泊酚是一种新型γ-氨基丁酸受体激动剂,在心血管影响最小、效能更高、注射疼痛减轻和安全范围更广方面优于丙泊酚。尽管有这些优势,但环泊酚的临床研究仍在不断涌现。本研究比较了环泊酚和丙泊酚与舒芬太尼联合使用时,在气管插管期间抑制心血管反应的半数有效剂量(ED)和不良反应。53例计划在全身麻醉下进行气管插管的成年患者入组,并根据随机数字表随机分配接受环泊酚(C组)或丙泊酚(P组)。使用标准化喉镜和气管内导管进行气管插管。采用 Dixon 上下法确定环泊酚和丙泊酚在抑制气管插管期间心血管反应的ED和95%有效剂量(ED)。根据预试验,环泊酚的初始剂量设定为0.35mg/kg(增量为0.01mg/kg),丙泊酚的初始剂量设定为2.0mg/kg(增量为0.1mg/kg)。应用概率分析得出剂量-反应曲线,同时持续监测不良反应。共纳入54名参与者,C组24名(排除1名),P组30名。概率分析显示,环泊酚抑制气管插管心血管反应的ED为0.326mg/kg(95%CI 0.304-0.337mg/kg),丙泊酚为1.541mg/kg(95%CI 1.481-1.599mg/kg)。插管后1分钟(p = 0.026)和3分钟(p = 0.016)时,P组心率显著高于C组。与两组基线值相比,插管前后收缩压和舒张压(SBP和DBP)均显著降低(p < 0.05)。C组注射疼痛明显减轻(p = 0.001),尽管两组其他不良反应发生率无统计学差异(p > 0.05)。临床试验注册:hppts://ClinicalTrials.gov;标识符:NCT06095570(2023年10月18日)。