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

NCT07194109 | Not Yet Recruiting Phase 4 DMC

• 2 other identifiers: PJ2025-06-9020250690
• Study Type: interventional
• Target: 558
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Adenotonsillar Hypertrophy

Keywords

remimazolam; neurodevelopment; propofol; children; tonsillectomy

Outcome Measures

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)》

  one year after surgery

Secondary Outcomes (5)

• Memory and learning ability

  The first to the third year after the operation

• Language and Reading Skills

  The first to the third year after the operation

• Executive Function and Attention

  The first to third year after operation

• Behavior and Emotion Assessment

  The first to third year after surgery

• Motor development

  The first to third years after surgery

Study Arms (2)

Remimazolam group

EXPERIMENTAL

patients who in this arm will receive remimazolam for general anesthesia induction and maintenance

Drug: Remimazolam based total intravenous anesthesia

propofol group

ACTIVE COMPARATOR

patients who in this arm will receive propofol for general anesthesia induction and maintenance

Drug: Propofol based general anesthesia

Interventions

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.

Remimazolam group

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.

propofol group

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Anhui Medical University: lead

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized controlled clinical study

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 26, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2030
• Last Updated: September 26, 2025

Record last verified: 2025-08