Journal of clinical anesthesia · 2025
Respiratory-related safety profiles of ciprofol (cipepofol) for anesthesia/sedation in Chinese elderly patients undergoing gastroscopy: a multicenter, parallel controlled clinical trial (REST trial).
СтатьяРандомизированное исследованиеМногоцентровое исследованиеСравнительное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Zhang Xiang, Zhu Tao, Chen Guo, Huang He, Duan Guangyou, Xiao Zhaoyang, Gao Jinxia, Liu Cunming, Huang Yahui, Hu Jiajia, Hu Jiang, Qiu Jinpeng, Liao Yanling, Gong Cansheng, Ma Yanran, Zhong Haiqing, Yuan Lvyi
Аннотация
BACKGROUND: A post-marketing, parallel-controlled clinical trial (REST trial) was conducted to evaluate the safety and efficacy of cipepofol versus propofol for the induction of anesthesia/sedation in Chinese elderly patients undergoing gastroscopy.
METHODS: All enrolled patients aged ≥65 years were assigned randomly in a 1:1 ratio to be administered intravenous cipepofol-0.3 mg/kg or propofol-1.5 mg/kg. The primary endpoint was incidence of respiratory-related adverse events (AEs) including respiratory depression (respiratory rate < 8 breaths/min lasting for >30 s), apnea (loss of thoracic movement for >15 s) and hypoxemia (SpO2 < 93 % lasting for >15 s). Secondary endpoints included: success rates of the gastroscopy procedure and gastroscope insertion; gastroscopy-related duration (successful anesthesia/sedation induction duration; time to full alertness; time to leaving the post-anesthesia care unit; gastroscope insertion duration); satisfaction rate for the anesthesia/sedation process and anesthetics.
RESULTS: Among 890 randomized patients, 871 were finally included in the full analysis set (FAS), with 431 receiving cipepofol and 440 receiving propofol. Patients treated with cipepofol had a significantly lower incidence of respiratory-related AEs compared to propofol treatment (FAS: 22.3 % vs. 33.9 %, per-protocol set: 20.6 % vs. 34.5 %, all P < 0.001), regardless of sex. Multivariable analysis revealed that the risk of patients experiencing respiratory-related AEs was 1.82 times higher in the propofol group compared to cipepofol group (P < 0.001). The success rates of the gastroscopy procedure and gastroscope insertion were both 100 % in the two groups. Gastroscopy procedure-related durations were shorter in propofol group compared to cipepofol group (all P < 0.05). Patients treated with cipepofol exhibited a significantly lower rate of treatment-emergent AEs (TEAEs) (55.0 % vs. 67.7 %, P < 0.001), TEAEs of special interest (53.4 % vs. 65.2 %, P < 0.001) and injection pain (2.6 % vs. 28.4 %, P < 0.001).
CONCLUSIONS: Cipepofol-0.3 mg/kg is a safe and effective intravenous anesthetic for Chinese elderly patients undergoing gastroscopy, especially complimented by lower incidences of respiratory-related AEs and injection pain.
CLINICAL TRIALS REGISTRATION: Chinese Clinical Trial Registry, ChiCTR2100052299, registered on October 24, 2021.
METHODS: All enrolled patients aged ≥65 years were assigned randomly in a 1:1 ratio to be administered intravenous cipepofol-0.3 mg/kg or propofol-1.5 mg/kg. The primary endpoint was incidence of respiratory-related adverse events (AEs) including respiratory depression (respiratory rate < 8 breaths/min lasting for >30 s), apnea (loss of thoracic movement for >15 s) and hypoxemia (SpO2 < 93 % lasting for >15 s). Secondary endpoints included: success rates of the gastroscopy procedure and gastroscope insertion; gastroscopy-related duration (successful anesthesia/sedation induction duration; time to full alertness; time to leaving the post-anesthesia care unit; gastroscope insertion duration); satisfaction rate for the anesthesia/sedation process and anesthetics.
RESULTS: Among 890 randomized patients, 871 were finally included in the full analysis set (FAS), with 431 receiving cipepofol and 440 receiving propofol. Patients treated with cipepofol had a significantly lower incidence of respiratory-related AEs compared to propofol treatment (FAS: 22.3 % vs. 33.9 %, per-protocol set: 20.6 % vs. 34.5 %, all P < 0.001), regardless of sex. Multivariable analysis revealed that the risk of patients experiencing respiratory-related AEs was 1.82 times higher in the propofol group compared to cipepofol group (P < 0.001). The success rates of the gastroscopy procedure and gastroscope insertion were both 100 % in the two groups. Gastroscopy procedure-related durations were shorter in propofol group compared to cipepofol group (all P < 0.05). Patients treated with cipepofol exhibited a significantly lower rate of treatment-emergent AEs (TEAEs) (55.0 % vs. 67.7 %, P < 0.001), TEAEs of special interest (53.4 % vs. 65.2 %, P < 0.001) and injection pain (2.6 % vs. 28.4 %, P < 0.001).
CONCLUSIONS: Cipepofol-0.3 mg/kg is a safe and effective intravenous anesthetic for Chinese elderly patients undergoing gastroscopy, especially complimented by lower incidences of respiratory-related AEs and injection pain.
CLINICAL TRIALS REGISTRATION: Chinese Clinical Trial Registry, ChiCTR2100052299, registered on October 24, 2021.