None
Conditions
Interventions
AB sequence:During the first invasive procedure under sedation, sedation is induced with propofol at 3 mg/kg, followed by esketamine administration at 0.5mg/kg. When the patients move or show signs of
BA sequence:During the first invasive procedure under sedation, sedation is induced with propofol at 3 mg/kg, followed by remifentanil administration at 1µg/kg. When the patients move or show signs of
Sponsors
Children's Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1.Diagnosed with acute lymphoblastic leukemia, acute myelogenous leukemia or meningeal leukemia following the initial bone marrow biopsy according to the WHO diagnostic criteria; 2.Children aged 6-12 years at trial entry; 3.Body mass index (BMI) 18–30kg/m^2; 4.American Society of Anesthesiologists (ASA) physical status II or III; 5.Patients are anticipated to undergo at least two similar invasive procedures, specifically bone marrow aspiration and lumbar puncture, during chemotherapy. A minimum washout period of five days is required between these procedures; 6.Being able to precisely articulate feelings and experiences.
Exclusion criteria
Exclusion criteria: 1.Children with severe cardiorespiratory conditions or other poorly controlled medical conditions that, in the investigator's professional judgment, would compromise the integrity of the trial; 2.Allergy or hypersensitivity to any of the study medication; 3.The child may experience nausea, vomiting and pain as a result of the illness itself or adverse reactions to medication; 4. History of psychological problems.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of desaturation events during the procedures; | — |
Secondary
| Measure | Time frame |
|---|---|
| The interruption rate of the procedure;Total dose of propofol;The number of times esketamine or remifentanil is added;Recovery time ;Distress behavior;A composite of sedation related adverse events after the procedures;Patient satisfaction;Operator satisfaction;Anesthetist satisfaction; | — |
Countries
China
Contacts
Public ContactWang Qian
Children's Hospital of Soochow University
Outcome results
None listed