Journal Article

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

An, Li-Xin, Qi, Xiu-Ru, Hao, Si-Qi, Li, Ying, Hao, Dan-Dan, Li, Xin-Ming

2025

Overview

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 [SpO 2 ] < 90% for > 10 s). Secondary outcomes include severe hypoxemia (SpO 2  ≤ 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.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Adolescent / Adult / Aged / Aged, 80 and over / Airway management / Anesthesia / Anesthesiology / Biomedicine / Blood pressure / Care and treatment / Clinical medicine / Clinical trials / Data collection / Dexmedetomidine / Dosage and administration / Double-Blind Method / Drug withdrawal / Equivalence Trials as Topic / Esketamine / Excitatory Amino Acid Antagonists - administration & dosage / Excitatory Amino Acid Antagonists - adverse effects / Female / Gastroscopy - adverse effects / Health Sciences / Humans / Hypertension / Hypnotics and Sedatives - administration & dosage / Hypnotics and Sedatives - adverse effects / Hypotension / Hypoxemia / Hypoxia / Hypoxia - chemically induced / Hypoxia - diagnosis / Hypoxia - etiology / Hypoxia - prevention & control / Informed consent / Intervention / Intubation / Ketamine / Ketamine - administration & dosage / Ketamine - adverse effects / Male / Medical personnel / Medical prognosis / Medical research / Medical screening / Medicine / Medicine & Public Health / Medicine, Experimental / Middle Aged / Narcotics / Obstructive sleep apnea / Painless gastroscopy / Patient safety / Procedural sedation / Propofol - administration & dosage / Propofol - adverse effects / Prospective Studies / Randomized Controlled Trials as Topic / Risk Factors / Sleep apnea / Sleep apnea syndromes / Sleep Apnea, Obstructive - complications / Sleep Apnea, Obstructive - diagnosis / Sleep Apnea, Obstructive - physiopathology / Statistics for Life Sciences / Study Protocol / Treatment Outcome / Young Adult