Remiazolam vs Propofol Total Intravenous Anesthesia on Postoperative Neurodevelopment After General Anesthesia in Children

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age3-6
SponsorThe First Affiliated Hospital of Anhui Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Remimazolam based total intravenous anesthesia

    Drug

    For patients who aged between 3 and 6 years old undergoing tonsillectomy or/and adenoidectomy, anesthesia induction will performed with remimazolam in a dose of 0.4 - 0.5 mg/kg anesthesia maintenance was administered with remimazolam at a rate of 1.0 - 3.0 mg/kg/h.

  • Propofol based general anesthesia

    Drug

    For patients who aged between 3 and 6 years old undergoing tonsillectomy or/and adenoidectomy, anesthesia induction will performed with propofol in a dose of 2.0 - 3.5 mg/kg , anesthesia maintenance was administered with propofol at a rate of 4 - 12 mg/kg/h.

Treatment groups

558 Participants
are divided into 2 treatment groups
Group A: Remimazolam groupExperimental treatment 1 intervention
Group B: propofol groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

full-scale intelligence quotient

assessed by trained physicians, using the Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition (Chinese Version) 《WPPSI-IV(CN)》

Time frame
one year after surgery

Secondary outcomes

1

Memory and learning ability

assessed by trained physicians, using the Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition (Chinese Version) 《WPPSI-IV(CN)》

Time frame
The first to the third year after the operation
2

Language and Reading Skills

assessed by trained physicians, using the Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition (Chinese Version) 《WPPSI-IV(CN)》

Time frame
The first to the third year after the operation
3

Executive Function and Attention

used by Behavior Rating Inventory of Executive Function for preschool (BRIEF-P)

Time frame
The first to third year after operation
4

Behavior and Emotion Assessment

used by Achenbach Child Behavior Checklist (CBCL)

Time frame
The first to third year after surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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