Li Xin-Ming, Hao Si-Qi, Qi Xiu-Ru, Hao Dan-Dan, Li Ying, An Li-Xin
Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, No. 95 Yongan Road, Xicheng District, Beijing, 100050, China.
Trials. 2025 Sep 26;26(1):364. doi: 10.1186/s13063-025-09098-w.
Propofol sedation in patients with Obstructive Sleep Apnea (OSA) frequently induces hypoxemia, posing significant clinical risks. Esketamine, an N-Methyl-D-Aspartate (NMDA) receptor antagonist, may reduce propofol requirements while preserving respiratory stability, but its efficacy in OSA patients remains unproven. At the studied dose (0.25 mg/kg), esketamine's potential side effects (transient hypertension) are expected to be mild and self-limited. Therefore, we aimed to test whether low-dose esketamine (0.25 mg/kg) can reduce the incidence of hypoxemia in moderate-to-high risk OSA patients during propofol-based painless gastroscopy.
This single-center, double-blind, randomized controlled superiority trial will enroll 294 patients (STOP-Bang score ≥ 3, 18-90 years, STOP-Bang = Snoring, Tiredness, Observed apnea, Pressure [blood], Body Mass Index [BMI], Age, Neck size, Gender.) undergoing gastroscopy. Participants will be randomized 1:1 to receive either esketamine (0.25 mg/kg) plus propofol or saline placebo plus propofol, stratified by age (18-65 vs. > 65 years) and OSA severity (STOP-Bang 5-6 vs. ≥ 7). The primary outcome is the incidence of hypoxemia (Peripheral Oxygen Saturation [SpO] < 90% for > 10 s). Secondary outcomes include severe hypoxemia (SpO ≤ 75% or ≤ 90% for ≥ 60 s), duration of hypoxemia, emergency airway management, propofol consumption, hemodynamic stability, involuntary body movements, procedure/recovery times, and clinician satisfaction (measured via 10-cm Visual Analog Scale [VAS]).
This protocol rigorously evaluates esketamine's potential to improve sedation safety in OSA patients, addressing a critical gap in peri-procedural care.
Chinese Clinical Trial Registry (ChiCTR2500099420). Registered on March 24, 2025 (Supplementary File 2). Si-Qi Hao is a co-first author with the same contribution as the first author. The corresponding author is Li-Xin An.
阻塞性睡眠呼吸暂停（OSA）患者使用丙泊酚镇静时常常会诱发低氧血症，带来重大临床风险。艾司氯胺酮是一种N-甲基-D-天冬氨酸（NMDA）受体拮抗剂，可能会减少丙泊酚用量，同时维持呼吸稳定性，但其对OSA患者的疗效尚未得到证实。在研究剂量（0.25mg/kg）下，预计艾司氯胺酮的潜在副作用（短暂性高血压）较为轻微且具有自限性。因此，我们旨在测试低剂量艾司氯胺酮（0.25mg/kg）能否降低中高风险OSA患者在丙泊酚无痛胃镜检查期间低氧血症的发生率。
这项单中心、双盲、随机对照优势试验将纳入294例接受胃镜检查的患者（STOP-Bang评分≥3，年龄18 - 90岁，STOP-Bang = 打鼾、疲倦、观察到的呼吸暂停、血压、体重指数[BMI]、年龄、颈围、性别）。参与者将按1:1随机分组，接受艾司氯胺酮（0.25mg/kg）加丙泊酚或生理盐水安慰剂加丙泊酚，并按年龄（18 - 65岁与>65岁）和OSA严重程度（STOP-Bang 5 - 6分与≥7分）分层。主要结局是低氧血症的发生率（外周血氧饱和度[SpO] < 90%持续>10秒）。次要结局包括严重低氧血症（SpO≤75%或≤90%持续≥60秒）、低氧血症持续时间、紧急气道管理、丙泊酚用量、血流动力学稳定性、不自主身体运动、操作/恢复时间以及临床医生满意度（通过10厘米视觉模拟量表[VAS]测量）。
本方案严格评估了艾司氯胺酮改善OSA患者镇静安全性的潜力，填补了围手术期护理中的一个关键空白。
中国临床试验注册中心（ChiCTR2500099420）。于2025年3月24日注册（补充文件2）。郝思齐是共同第一作者，贡献与第一作者相同。通讯作者是安立新。
