目的：环丙泊酚，一种新型的静脉麻醉剂,在接受结肠镜检查的患者中提供快速恢复。我们的目的是在非手术室环境中，包括内镜黏膜下剥离术，与丙泊酚镇静或麻醉的有效性和安全性进行比较，内镜逆行胰胆管造影术,和柔性支气管镜（FB）。
方法：前瞻性，随机化，双盲,平行组临床试验。
方法：大学附属教学医院。
方法：我们招募了2021年10月至2021年12月进行内镜手术的207例患者。
方法：根据诱导期间的剂量将患者随机分为三组（每组69例）：1）顺丙泊酚6mg/kg/h，2）环丙泊酚8mg/kg/h，或3)丙泊酚40mg/kg/h。在整个过程中给予了环丙泊酚或丙泊酚。
方法：主要结果是手术的镇静或麻醉成功率。次要结果包括诱导时间，内窥镜插入时间,恢复时间,放电时间,药物相关不良事件（AE）的发生率，神经和炎症结果。
结果：三组手术成功率均为100%。6（3.3±1.0min）和8mg/kg/h（2.9±0.6min）环丙泊酚组的诱导时间长于仅接受FB的患者的丙泊酚组（2.5±0.6min）（p=0.004）。三组患者完全警觉和从麻醉后监护病房出院的时间相当(p>0.05)。丙泊酚和6和8mg/kg/h顺丙泊酚组的药物相关不良事件发生率为84.1%,76.8%,和79.7%。环丙泊酚组未报告注射时疼痛。三组之间的神经系统结果和炎症反应具有可比性。
结论：环丙泊酚诱导的镇静或麻醉水平与异丙酚在非手术室环境中诱导的水平相当，但FB患者的诱导时间延长。环丙泊酚的安全性与异丙酚相似。据报道，环丙泊酚注射时没有疼痛。
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).
Prospective, randomized, double-blind, parallel-group clinical trial.
University-affiliated teaching hospital.
We recruited 207 patients scheduled for an endoscopic procedure from October 2021 to December 2021.
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.
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.
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.
Ciprofol induced a level of sedation or anesthesia equivalent to that induced by propofol in non-operating 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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