Remiazolam vs Propofol Total Intravenous Anesthesia on Postoperative Neurodevelopment After Gener… (NCT07194109) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Remiazolam vs Propofol Total Intravenous Anesthesia on Postoperative Neurodevelopment After General Anesthesia in Children
558 participantsStarted 2025-10-01
Plain-language 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 after general anesthesia when compared with propofol. It will also learn about the safety of remimazolam used for children. The main questions it aims to answer are:
* Does remimazolam improve the postoperative neurodevelopmental outcomes of the children after general anesthesia compared with propofol?
* What medical problems do participants have when receive remimazolam for general anesthesia? Researchers will compare remimazolam to propofol to see if remimazolam improve the postoperative neurodevelopmental outcomes of the children after general anesthesia.
Participants will:
* Receive remimazolam or propofol for general anesthesia induction and maintenance
* At 1-3 years after the surgery, the Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition was used for face-to-face assessment of the children's neurodevelopmental status.
* Use scales such as BRIEF-P and CBCL to conduct face-to-face assessments of the patient's cognitive functions in other areas.
Who can participate
Age range3 Years – 6 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.;
What they're measuring
1
full-scale intelligence quotient
Timeframe: one year after surgery
Trial details
NCT IDNCT07194109
SponsorThe First Affiliated Hospital of Anhui Medical University