Clinical TrialNot yet recruiting

Observation on the Effect of Low-Dose Esketamine Combined with Propofol on Depressive Mood in Pediatric Tumor Patients Undergoing General Anesthesia for Bone Marrow Puncture

This observational cohort study (n=236) in China examined the effect of low-dose esketamine combined with propofol on depressive mood in paediatric tumour patients undergoing general anaesthesia for bone marrow puncture. Children aged 4 to 16 years of both sexes were included, with 118 participants in the observation group and 118 in the control group. The study focused on anaesthesia in paediatric oncology patients and compared outcomes between groups receiving the anaesthetic regimen versus standard management, although the trial record does not specify a detailed comparator intervention. The primary outcome was depression score, assessed in the perioperative period, with the timing of measurement not further specified in the available record. Secondary outcomes included the incidence of hypoxaemia and emergence time, indicating that the study also evaluated safety and recovery after anaesthesia. No Phase designation was provided. Sponsored by Children’s Hospital of Soochow University, this study adds to clinical evidence from China on the potential psychological and anaesthetic effects of esketamine in children undergoing painful diagnostic procedures.

Target Enrollment
Not specified
Study Type
Phase NA observational
Design
Non-randomized

Participants

Ages
416
Sexes
Male & Female

Inclusion Criteria

  • Inclusion criteria: 1. Aged between 4 and 16 years;2. Pediatric patients initially diagnosed with a tumor and scheduled to undergo bone marrow puncture under general anesthesia;3. American Society of Anesthesiologists (ASA) physical status classification of I to III;4. Legal guardians fully understand the study, voluntarily participate, and provide signed informed consent.

Exclusion Criteria

  • Exclusion criteria: 1. Age >16 years or <4 years;2. American Society of Anesthesiologists (ASA) physical status classification IV–V;3. History of psychological disorders or psychiatric diseases;4. Use of medications affecting the central nervous system;5. Patients with impaired consciousness;6. Patients with elevated intracranial pressure;7. Patients with elevated intraocular pressure;8. Patients with congenital heart disease exhibiting right-to-left shunt.

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase NA
  • Type
    observational
  • Design
    Non-randomized
  • Timeline
    Start: 2026-01-01

Locations

China

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