Liu Ying, Song Nan, Zhang Jing-Tao, Yan Jing, Peng Ke, Liu Hong, Shan Xi-Sheng, Ji Fu-Hai
Department of Anesthesiology, First Affiliated Hospital of Soochow University, Suzhou, China.
Institute of Anesthesiology, Soochow University, Suzhou, China.
Ann Med. 2025 Dec;57(1):2548389. doi: 10.1080/07853890.2025.2548389. Epub 2025 Aug 20.
Same-visit bidirectional endoscopic procedures under sedation are frequently performed in elderly patients. However, the optimal sedation regimen for elderly patients remains uncertain. This study seeks to evaluate the hypothesis that intravenous lidocaine, when used as an adjunct to propofol sedation, reduces the incidence of sedation-related adverse events during these procedures.
This multicenter, randomized, double-blind, placebo-controlled trial will enroll 648 elderly patients scheduled for same-visit bidirectional endoscopy under sedation at four hospitals in China. Participants will be randomized in a 1:1 ratio to receive either intravenous lidocaine or normal saline (placebo), stratified by study center ( = 324 per group). All patients will receive sufentanil (0.1 μg/kg) followed by either lidocaine (1.5 mg/kg) or an equal volume of normal saline, and then propofol (1.0 mg/kg) for induction. Propofol will be titrated to maintain the target sedation level. The primary outcome is a composite of desaturation (peripheral oxygen saturation < 90%) and hypotension (systolic blood pressure < 90 mmHg or > 20% reduction from baseline). Secondary outcomes include total propofol dose, incidence of involuntary body movements, postoperative pain and fatigue scores, and recovery time. Analyses will follow a modified intention-to-treat approach.
We hypothesize that adjunctive lidocaine with propofol-based sedation will reduce the incidence of intraoperative desaturation and hypotension in elderly patients undergoing same-visit bidirectional endoscopy. The findings will contribute to optimizing sedation strategies in this vulnerable population.
Chinese Clinical Trial Registry (ChiCTR2400087583).
在老年患者中，经常在镇静状态下进行同次就诊的双向内镜检查。然而，老年患者的最佳镇静方案仍不确定。本研究旨在评估以下假设：静脉注射利多卡因作为丙泊酚镇静的辅助用药，可降低这些检查过程中与镇静相关不良事件的发生率。
这项多中心、随机、双盲、安慰剂对照试验将纳入中国四家医院计划在镇静状态下进行同次就诊双向内镜检查的648例老年患者。参与者将按1:1的比例随机分组，接受静脉注射利多卡因或生理盐水（安慰剂），并按研究中心分层（每组324例）。所有患者将先接受舒芬太尼（0.1μg/kg），然后接受利多卡因（1.5mg/kg）或等体积的生理盐水，接着接受丙泊酚（1.0mg/kg）进行诱导。丙泊酚将进行滴定以维持目标镇静水平。主要结局是低氧血症（外周血氧饱和度<90%）和低血压（收缩压<90mmHg或较基线降低>20%）的复合指标。次要结局包括丙泊酚总剂量、不自主身体运动的发生率、术后疼痛和疲劳评分以及恢复时间。分析将采用改良的意向性分析方法。
我们假设丙泊酚镇静联合利多卡因可降低接受同次就诊双向内镜检查的老年患者术中低氧血症和低血压的发生率。这些发现将有助于优化这一脆弱人群的镇静策略。
中国临床试验注册中心（ChiCTR2400087583）。
