Status:
NOT_YET_RECRUITING
Remiazolam vs Propofol Total Intravenous Anesthesia on Postoperative Neurodevelopment After General Anesthesia in Children
Lead Sponsor:
The First Affiliated Hospital of Anhui Medical University
Conditions:
Adenotonsillar Hypertrophy
Eligibility:
All Genders
3-6 years
Phase:
PHASE4
Brief Summary
The goal of this clinical trial is to learn the effects of remimazolam for total intravenous anesthesia on the neurodevelopment of children aged 3-6 years who underwent tonsil/adenoid removal surgery ...
Eligibility Criteria
Inclusion
- Age: 3-6 years old;
- Planned to undergo elective non-neurological, non-cardiac, and non-liver surgery under general anesthesia (abdominal surgery, orthopedic surgery, urological surgery, otolaryngological surgery, etc.);
- Expected anesthesia duration to be more than 30 minutes;
- ASA classification I-II;
- BMI 14-25 kg/m2;
- Postoperative plan not to be admitted to ICU;
- Parents or legal guardians of the child have given informed consent;
- Capable of communicating in Chinese.
Exclusion
- Those who were exposed to general anesthetic drugs during infancy or in the late pregnancy of the mother;
- Known chromosomal abnormalities or other known acquired or congenital diseases that may affect neural development, such as cerebral palsy, autism spectrum disorder or attention deficit hyperactivity disorder (ADHD), etc.;
- Patients with severe liver dysfunction (Child-Pugh C grade);
- Patients with severe kidney dysfunction (requiring dialysis before surgery);
- Patients with a history of congenital heart disease requiring surgery or drug treatment;
- Those allergic to the study drugs remimazolam or propofol;
- Any known neural damage, such as cystic periventricular leukomalacia or grade 3 or 4 intraventricular hemorrhage;
- Social or geographical factors that may lead to postoperative loss of follow-up;
- Planned to undergo two surgeries within 7 days after the surgery;
- Those currently participating in other clinical trials;
- Those receiving special care or living in social welfare institutions or any other factors that may affect their ability to participate in the study.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2030
Estimated Enrollment :
558 Patients enrolled
Trial Details
Trial ID
NCT07194109
Start Date
October 1 2025
End Date
October 1 2030
Last Update
September 26 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.