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.
Xin-Ming Li, Si-Qi Hao, Xiu-Ru Qi, Dan-Dan Hao, Ying Li, Li-Xin An
Trials September 26, 2025 DOI: 10.1186/s13063-025-09098-w (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Double-blind Peer reviewed |
|---|---|
| Sample size | 294 |
| Population | Adults (18-90 years) with moderate-to-high risk of obstructive sleep apnea (STOP-Bang score ≥ 3) undergoing painless gastroscopy |
| Interventions | Esketamine Propofol |
| Dose | 0.25 mg/kg |
| Topics | Esketamine |
| Keywords | Obstructive sleep apnea Painless gastroscopy Procedural sedation Esketamine-propofol Hypoxemia prevention hypoxemia Dangerous oxygen drops Reduce hypoxemia |
| Citations | 2 |
| Key findings | The protocol describes a planned trial to test whether low-dose esketamine (0.25 mg/kg) plus propofol reduces the incidence of hypoxemia compared to propofol alone in moderate-to-high risk OSA patients; results are not yet reported. |
Abstract
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 [SpO2] 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]). 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.