【罂粟摘要】环泊酚用于非手术室镇静和麻醉的有效性和安全性

环泊酚用于非手术室镇静和麻醉的有效性和安全性

贵州医科大学    麻醉与心脏电生理课题组

翻译：潘志军

编辑：宋雨婷

审校：曹莹

背景：

环泊酚是一种新型静脉麻醉药，可使结肠镜检查患者迅速苏醒。本研究旨在比较环泊酚与丙泊酚在非手术室环境下镇静或麻醉的有效性和安全性，包括内镜下粘膜剥离、经内镜逆行胰胆管造影和纤维支气管镜检查(FB)。

试验设计、地点及受试对象：

本研究为一项前瞻性、随机、双盲、平行组临床试验，于复旦大学附属中山医院开展。本研究纳入了207名在2021年10月至2021年12月期间拟行内镜手术的患者。

干预措施及测量方法：

根据诱导剂量将患者随机分为三组(n = 69)：1)环泊酚6mg /kg/h；2)环泊酚8mg /kg/h；3)丙泊酚40mg /kg/h。在整个手术过程中仅使用环泊酚或丙泊酚。主要结局指标为手术中镇静或麻醉的成功率。次要结局指标包括诱导时间、内镜插入时间、恢复时间、出院时间、药物相关不良事件(AEs)发生率、神经和炎症指标。

结果：

三组手术成功率均为100%。仅在FB患者中，6(3.3±1.0 min)和8 mg/kg/h(2.9±0.6 min)环泊酚组诱导时间长于丙泊酚组(2.5±0.6 min) (P =0.004)。三组患者完全清醒时间和出麻醉后恢复室时间具有可比性(P > 0.05)。丙泊酚组和6、8 mg/kg/h环泊酚组药物相关不良事件发生率分别为84.1%、76.8%和79.7%。环泊酚组无注射痛。三组间神经指标和炎症反应无显著差异。

结论：

环泊酚诱导的镇静或麻醉水平与非手术室环境下丙泊酚诱导的镇静或麻醉水平相当，但在接受FB的患者中诱导时间延长。环泊酚的安全性与丙泊酚相似。环泊酚未发生注射痛。

原始文献来源：

Jing Zhong,Jinlin Zhang, Yu Fan,et al.Efficacy and safety of Ciprofol for procedural sedation and anesthesia in non-operating room settings [J]. (J Clin Anesth. 2023 May).

英文原文

Efficacy and safety of Ciprofol for procedural sedation and anesthesia in non-operating room settings

Study objective: Ciprofol, a novel intravenous anesthetic, provides rapid recovery in patients undergoing colonoscopy. We aimed to examine the efficacy and safety of ciprofol in comparison with propofol for sedation or anesthesia in non-operating room settings including endoscopic submucosal dissection, endoscopic retrograde cholangiopancreatography, and flexible bronchoscopy (FB).

Design: Prospective, randomized, double-blind, parallel-group clinical trial.

Setting: University-affiliated teaching hospital.

Patients: We recruited 207 patients scheduled for an endoscopic procedure from October 2021 to December 2021.

Interventions: Patients were randomized into three groups according to the dose during induction (n = 69 each): 1) ciprofol 6 mg/kg/h, 2) ciprofol 8 mg/kg/h, or 3) propofol 40 mg/kg/h. Ciprofol or propofol was administered throughout the procedure.

Measurements: The primary outcome was the success rate of sedation or anesthesia for the procedures. Secondary outcomes included induction time, endoscope insertion time, recovery time, discharge time, incidence of drug- related adverse events (AEs), neurological and inflammatory outcomes.

Main results: The procedure success rates in the three groups were 100%. The induction time in the 6 (3.3±1.0 min) and 8 mg/kg/h (2.9±0.6 min) ciprofol groups was longer than that in the propofol group (2.5±0.6 min) only in patients undergoing FB (p=0.004). The time for patients to be fully alert and discharged from the post- anesthesia care unit was comparable across the three groups (p>0.05). The incidence of drug-related AEs in the propofol and 6 and 8 mg/kg/h ciprofol groups was 84.1%, 76.8%, and 79.7%. No pain on injection was reported by ciprofol groups. Neurological outcomes and inflammatory responses were comparable among the three groups.

Conclusions: Ciprofol induced a level of sedation or anesthesia equivalent to that induced by propofol in nonoperating room settings except for a prolonged induction time in patients undergoing FB. Ciprofol had a safety profile similar to that of propofol. No pain on injection was reported by ciprofol.   

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