Children with gastrointestinal symptoms or suspected digestive system diseases who are scheduled to undergo elective combined gastroscopy and colonoscopy.
Conditions
Interventions
Oxycodone group:Oxycodone combined with propofol sedation
Sponsors
Capital Center For Children’s Health, Capital Medical University
Eligibility
Sex/Gender
All
Age
6 Years to 14 Years
Inclusion criteria
Inclusion criteria: 1. Aged 6–14 years; 2. Scheduled to undergo elective painless gastrointestinal endoscopy; 3. American Society of Anesthesiologists (ASA) physical status I–II; 4. Written informed consent obtained from the subject and their guardian.
Exclusion criteria
Exclusion criteria: 1. Expected need for complex therapeutic endoscopic procedures, such as resection of large polyps, endoscopic hemostasis, dilation, or foreign body removal; 2. Body mass index (BMI) = the 95th percentile, or obvious obesity that may increase the risk of sedation; 3. Significant gastroesophageal reflux, frequent vomiting, intestinal obstruction, or high risk of aspiration; 4. Upper respiratory tract infection, significant cough, fever, or wheezing within the past 2 weeks; 5. Known difficult airway, severe obstructive sleep apnea, or airway malformation; 6. Severe cardiac, pulmonary, hepatic, or renal dysfunction; 7. Neurological disease, developmental delay, or any condition that may affect the assessment of sedation response; 8. Use of opioids, sedative-hypnotics, or other medications that may affect study outcomes within 24 hours before the examination; 9. Allergy to oxycodone, propofol, or other study-related medications; 10. Any other condition that, in the investigator’s judgment, makes the subject unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ED90 of oxycodone; | — |
Secondary
| Measure | Time frame |
|---|---|
| Use of rescue anesthetic medication;Recovery-period adverse reactions and unplanned medical interventions;Satisfaction of endoscopists, anesthesiologists, and guardians;Overall clinical success rate;procedure duration;Recovery and PACU outcomes;Intra-procedural respiratory and circulatory adverse events;Procedural response events; | — |
Countries
China
Contacts
Public ContactChen Ying
Capital Center For Children’s Health, Capital Medical University
Outcome results
None listed