Safety and efficacy of esketamine versus remifentanil as adjuncts to propofol sedation in children undergoing haematologic-oncologic procedures in China: a single-centre, randomised, controlled, crossover trial protocol.

INTRODUCTION

Adequate sedation is essential for paediatric patients undergoing invasive haematologic-oncologic procedures. The combination of propofol and remifentanil is commonly used yet is associated with respiratory depression. Esketamine has anaesthetic, analgesic and sympathomimetic properties and is known to cause less respiratory depression than other sedatives. This study aims to assess esketamine versus remifentanil in combination with propofol for invasive haematological-oncological procedures for paediatric patients.

METHODS AND ANALYSIS: This prospective, randomised, double-blind, two-period crossover trial will include 80 paediatric patients aged 6-12 years, with American Society of Anesthesiologists Physical Status II to III, who are scheduled to undergo repeated invasive procedures including bone marrow aspirates and lumbar punctures under sedation. Participants will be randomised to two sequences: AB or BA. In sequence AB, children will receive propofol (3 mg/kg) and esketamine (0.5 mg/kg) in period 1 and propofol (3 mg/kg) and remifentanil (1 µg/kg) in period 2. In sequence BA, the order is reversed. The primary endpoint of this trial is the incidence of desaturation events, defined as SpO2<90% during the sedation and recovery. The secondary endpoints include: (1) the interruption rate of the procedure; (2) total dose of propofol; (3) the number of times esketamine or remifentanil is added; (4) recovery time; (5) distress behaviour; (6) a composite of sedation-related adverse events, including psychotomimetic effects (hallucinations, nightmares, fatigue, dizziness and headache), nausea, vomiting, bradycardia and hypotension; (7) operator satisfaction; (8) patient satisfaction and (9) anaesthetist satisfaction.

ETHICS AND DISSEMINATION: The trial was approved by the Ethics Committee of the Children's Hospital of Soochow University (Approval No. 2025008). The results of this trial will be submitted for peer review and publication in a scientific journal.

TRIAL REGISTRATION NUMBER: ChiCTR2500098533.