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Comparison of the efficacy and safety of ciprofol and propofol for ERCP anesthesia in older patients: A single-center randomized controlled clinical study
单中心随机对照比较环泊酚和丙泊酚用于老年患者ERCP麻醉的有效性和安全性
摘要
Study objectives: Ciprofol is a novel agonist at the gamma-aminobutyric acid-A (GABAA) receptor, exhibiting better cardiovascular stability and rapid recovery. The objective of this study was to compare the efficacy and safety of ciprofol and propofol for endoscopic retrograde cholangiopancreatography (ERCP) anesthesia in older patients.
研究目的：环泊酚是一种新型的γ-氨基丁酸-A受体激动剂，表现出更好的心血管稳定性和快速恢复。本研究的目的是比较环泊酚和丙泊酚在老年患者内窥镜逆行胰胆管造影术(ERCP)麻醉中的有效性和安全性。
Design: A single-center, randomized, parallel controlled clinical study.
设计：单中心、随机、平行对照临床研究。
Setting: General Hospital of Northern Theater Command.
单位：北部战区总医院。
Patients: We recruited 284 patients and intended to conduct ERCP from November 2021 to June 2022.
患者：我们招募了284名患者，计划在2021年11月至2022年6月期间进行ERCP。
Interventions: Patients scheduled for ERCP were randomly assigned to two groups (n = 142 each): ciprofol group (anesthesia induction 0.3–0.4 mg/kg, anesthesia maintenance 0.8–1.2 mg/kg/h) and propofol group (anesthesia induction 1.5–2.0 mg/kg, anesthesia maintenance 4-12 mg/kg/h).
干预：择期行ERCP的患者随机分为两组(n=142)：环泊酚组(麻醉诱导0.3~0.4 mg/kg，麻醉维持0.8~1.2 mg/kg/h)和丙泊酚组(麻醉诱导1.5~2.0 mg/kg，麻醉维持4~12 mg/kg/h)。
Measurements: The primary outcome was sedation success rate, defined as the proportion of patients with successful anesthesia induction. Secondary outcomes encompassed the time of successful induction, the time of complete recovery, the time of leaving the room and the incidence rate of adverse events (hypoxemia, hypotension and injection pain).
测量：主要结果是镇静成功率，定义为麻醉诱导成功的患者的比例。次要结果包括成功诱导的时间、完全恢复的时间、离开房间的时间和不良事件(低氧血症、低血压和注射疼痛)的发生率。
主要结果：两组镇静成功率均为100%。镇静成功率差值的95%可信区间为(−2.63%，2.63%)，下限大于−非劣限8%。环泊酚组镇静诱导成功时间(38.4±6.5min)长于丙泊酚组(30.6±6.2min，P<0.05)，完全恢复时间(12.8±5.8min)短于异丙酚组(16.9±5.0min，P<0.05)。环泊酚组离室时间(21.8±5.8min)明显短于丙泊酚组(25.9±5.1min，P<0.05)。环泊酚组注射痛发生率(2%)低于丙泊酚组(25%)(P<0.05)。其他结果没有显示出统计学上的差异。
Main results: The success rate of sedation in both groups was 100 %. The 95 % CI of the difference of sedation success rate was (− 2.63 %, 2.63 %), and the lower limit was greater than the non-inferiority limit of −8 %.The time of successful sedation induction in ciprofol group (38.4 ± 6.5 s) was longer than that in propofol group (30.6 ± 6.2 s, p < 0.05).The time of complete recovery in ciprofol group (12.8 ± 5.8 min) was shorter than that in propofol group (16.9 ± 5.0 min, p < 0.05). The time of leaving the room in ciprofol group (21.8 ± 5.8 min) was shorter than those in propofol group (25.9 ± 5.1 min, p < 0.05). The incidence of injection pain in ciprofol group (2 %) was lower than that in the propofol group (25 %, p < 0.05). Other outcomes didn't show statistical differences.
主要结果：两组镇静成功率均为100%。镇静成功率差值的95%可信区间为(−2.63%，2.63%)，下限大于−非劣限8%。异丙酚组镇静诱导成功时间(38.4±6.5min)长于异丙酚组(30.6±6.2min，P<0.05)，完全恢复时间(12.8±5.8min)短于异丙酚组(16.9±5.0min，P<0.05)。异丙酚组离室时间(21.8±5.8min)明显短于异丙酚组(25.9±5.1min，P<0.05)。异丙酚组注射痛发生率(2%)低于异丙酚组(25%)(P<0.05)。其他结果没有显示出统计学上的差异。
Conclusions: Compared with propofol, ciprofol exhibited a comparable level of sedation in older patients undergoing ERCP, and recovery was safe and rapid with less injection pain.
结论：与丙泊酚相比，环泊酚在老年ERCP患者中的镇静程度相当，且恢复安全、快速，注射疼痛较少。
结果
3.2. Primary outcome Both groups of patients successfully completed the operation, and the success rate of sedation was 100 %. The 95 % CI of the difference of sedation success rate was (− 2.63 %, 2.63 %), and the lower limit was greater than the non-inferiority limit of - 8 %, that is, ciprofol group was non-inferior to propofol group in the success rate of sedation.
3.2.主要结局两组患者均顺利完成手术，镇静成功率均为100%。镇静成功率差异的95%CI为（− 2.63%，2.63%），下限大于非劣效性界限-8%，即环泊酚组在镇静成功率上非劣效于丙泊酚组。
3.3.次要结果
3.3.1.两组不同时间点生命体征及BIS比较T0时两组MAP、HR、SpO 2差异无统计学意义。从T1开始，两组的MAP、HR和SpO 2均趋于降低，随后两组的MAP和HR均升高，可能是由于手术内窥镜的影响。T1 ~ T5，环泊酚组MAP、HR、SpO 2明显高于丙泊酚组（p < 0.05），T0 ~ T5 BIS无明显差异（图3）。
3.3.2.镇静效果评价：环泊酚组成功镇静诱导时间（38.4 ± 6.05s）长于丙泊酚组（30.6 ± 6.02s，p < 0.0001）。环泊酚组完全苏醒时间（12.8 ± 5.8min）短于丙泊酚组（16.9 ± 5.0min，p < 0.0001），环泊酚组完全苏醒时间（21.8 ± 5.8min）短于丙泊酚组（25.9 ± 5.1min，p < 0.0001）。
3.3. Secondary outcomes
3.3.1. Comparison ofvital signs and BIS at different time points between the two groups There was no significant difference in MAP, HR and SpO2 between the two groups at T0. From T1, MAP, HR, and SpO2 tended to decrease in both groups, followed by an increase in MAP and HR in both groups, possibly due to the influence of the operating endoscope. From T1 to T5, MAP, HR and SpO2 in the ciprofol group were significantly higher than those in the propofol group (p < 0.05), and there was no significant difference in BIS at T0-T5 (Fig. 3).
3.3.次要结果
3.3.1.两组不同时间点生命体征及BIS比较T0时两组MAP、HR、SpO 2差异无统计学意义。从T1开始，两组的MAP、HR和SpO 2均趋于降低，随后两组的MAP和HR均升高，可能是由于手术内窥镜的影响。T1 ~ T5，环丙酚组MAP、HR、SpO 2明显高于丙泊酚组（p < 0.05），T0 ~ T5 BIS无明显差异（图3）。
3.3.2. Efficacy assessment of sedation The time of successful sedation induction in ciprofol group (38.4 ± 6.5 s) was longer than that in propofol group (30.6 ± 6.2 s, p < 0.0001). The time of complete recovery in ciprofol group (12.8 ± 5.8 min) was shorter than that in propofol group (16.9 ± 5.0 min, p < 0.0001) The time of leaving the room in ciprofol group (21.8 ± 5.8 min) was shorter than that in propofol group (25.9 ± 5.1 min, p < 0.0001, Table 2).
3.3.2.镇静效果评价：环丙异丙酚组成功镇静诱导时间（38.4 ± 6.05s）长于丙泊酚组（30.6 ± 6.02s，p < 0.0001）。异丙酚组完全苏醒时间（12.8 ± 5.8min）短于异丙酚组（16.9 ± 5.0min，p < 0.0001），异丙酚组完全苏醒时间（21.8 ± 5.8min）短于异丙酚组（25.9 ± 5.1min，p < 0.0001）。
3.3.3. Safety assessments of sedation A total of 37 adverse events occurred in 142 patients in the ciprofol group. No serious adverse events occurred, and no patient dropped out of the study due to adverse events. All adverse events recovered after treatment. In the ciprofol group, adverse events including hypoxemia (7 patients, 5 %), hypotension (27 patients, 19 %), and the injection pain (3 patients, 2 %). A total of 81 adverse events occurred in 142 patients in the propofol group. No serious adverse events occurred, and no patient dropped out of the study due to adverse events. All adverse events were recovered after treatment. In the propofol group, the adverse events including hypoxemia (15 patients, 11 %), hypotension (31 patients, 22 %), and injection pain (35 patients, 25 %). The incidence of injection pain was lower in ciprofol group than in the propofol group (p < 0.05, Table 3).
3.3.3.镇静的安全性评估
在环泊酚组的142名患者中，总共发生了37起不良事件。未发生严重不良事件，无患者因不良事件退出研究。所有不良事件均在治疗后恢复。在环泊酚组中，不良事件包括低氧血症（7例患者，5%）、低血压（27例患者，19%）和注射疼痛（3例患者，2%）。丙泊酚组142例患者共发生81例不良事件。未发生严重不良事件，无患者因不良事件退出研究。所有不良事件经治疗后均痊愈。丙泊酚组不良反应包括低氧血症（15例，11%）、低血压（31例，22%）和注射痛（35例，25%）。环泊酚组注射痛的发生率低于丙泊酚组（p < 0.05，表3）。
