{"title":"低剂量艾氯胺酮对中高风险阻塞性睡眠呼吸暂停患者胃镜检查时低氧血症的影响：一项前瞻性、随机、对照试验方案","authors":"Xin-Ming Li, Si-Qi Hao, Xiu-Ru Qi, Dan-Dan Hao, Ying Li, Li-Xin An","doi":"10.1186/s13063-025-09098-w","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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<sub>2</sub>] < 90% for > 10 s). Secondary outcomes include severe hypoxemia (SpO<sub>2</sub> ≤ 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]).</p><p><strong>Discussion: </strong>This protocol rigorously evaluates esketamine's potential to improve sedation safety in OSA patients, addressing a critical gap in peri-procedural care.</p><p><strong>Trial registration: </strong>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.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"364"},"PeriodicalIF":2.0000,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12465855/pdf/","citationCount":"0","resultStr":"{\"title\":\"Effects of low-dose esketamine on hypoxemia during gastroscopy in patients with moderate-to-high risk obstructive sleep apnea: protocol for a prospective, randomized, controlled trial.\",\"authors\":\"Xin-Ming Li, Si-Qi Hao, Xiu-Ru Qi, Dan-Dan Hao, Ying Li, Li-Xin An\",\"doi\":\"10.1186/s13063-025-09098-w\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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<sub>2</sub>] < 90% for > 10 s). Secondary outcomes include severe hypoxemia (SpO<sub>2</sub> ≤ 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]).</p><p><strong>Discussion: </strong>This protocol rigorously evaluates esketamine's potential to improve sedation safety in OSA patients, addressing a critical gap in peri-procedural care.</p><p><strong>Trial registration: </strong>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. 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Effects of low-dose esketamine on hypoxemia during gastroscopy in patients with moderate-to-high risk obstructive sleep apnea: protocol for a prospective, randomized, controlled trial.
Background: 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.
Methods: 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 [SpO2] < 90% for > 10 s). Secondary outcomes include severe hypoxemia (SpO2 ≤ 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]).
Discussion: This protocol rigorously evaluates esketamine's potential to improve sedation safety in OSA patients, addressing a critical gap in peri-procedural care.
Trial registration: 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.
期刊介绍：
Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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