Adenotonsillar HypertrophyPhase 4REMPPONNCT07194109
Remiazolam vs Propofol Total Intravenous Anesthesia on Postoperative Neurodevelopment After General Anesthesia in Children
A Phase 4 study testing Remimazolam based total intravenous anesthesia and Propofol based general anesthesia in people with Adenotonsillar Hypertrophy, run by The First Affiliated Hospital of Anhui Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Adenotonsillar Hypertrophy
- What is being tested?
- Remimazolam based total intravenous anesthesia and Propofol based general anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 558 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Oct 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
About this study
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.
Read more
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
- Being tested
- Remimazolam based total intravenous anesthesia, Propofol based general anesthesia
- Keywords
- remimazolam, neurodevelopment, propofol, children, tonsillectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam based total intravenous anesthesiaDrug
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 anesthesiaDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam group | Experimental | patients who in this arm will receive remimazolam for general anesthesia induction and maintenance Receives: Drug: Remimazolam based total intravenous anesthesia |
| propofol group | Active comparator | patients who in this arm will receive propofol for general anesthesia induction and maintenance Receives: Drug: Propofol based general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
full-scale intelligence quotient
assessed by trained physicians, using the Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition (Chinese Version) 《WPPSI-IV(CN)》
Measured: one year after surgery
Secondary outcomes (5)
Memory and learning ability
assessed by trained physicians, using the Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition (Chinese Version) 《WPPSI-IV(CN)》
Measured: The first to the third year after the operation
Language and Reading Skills
assessed by trained physicians, using the Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition (Chinese Version) 《WPPSI-IV(CN)》
Measured: The first to the third year after the operation
Executive Function and Attention
used by Behavior Rating Inventory of Executive Function for preschool (BRIEF-P)
Measured: The first to third year after operation
Behavior and Emotion Assessment
used by Achenbach Child Behavior Checklist (CBCL)
Measured: The first to third year after surgery
Motor development
used by Movement Assessment Battery for Children-Second Edition(MABC-2)
Measured: The first to third years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2030 (estimated)
- Study completion1 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenotonsillar HypertrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled clinical study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 558 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194109
- Sponsor's protocol ID
- PJ2025-06-90
- Other IDs
- 20250690
- Acronym
- REMPPON
- Status last verified
- Aug 2025
- First submitted
- 3 Sep 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remiazolam vs Propofol Total Intravenous Anesthesia on Postoperative Neurodevelopment After General Anesthesia in Children
- ClinicalTrials.gov ID
- NCT07194109
- Acronym / sponsor ID
- REMPPON / PJ2025-06-90
- Conditions
- Adenotonsillar Hypertrophy
- Keywords
- remimazolam, neurodevelopment, propofol, children, tonsillectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 558 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2030 (estimated)
- Study completion
- 1 Oct 2030 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled clinical study
| Arm | Type | Receives |
|---|---|---|
| Remimazolam group | Experimental | Drug: Remimazolam based total intravenous anesthesiapatients who in this arm will receive remimazolam for general anesthesia induction and maintenance |
| propofol group | Active comparator | Drug: Propofol based general anesthesiapatients who in this arm will receive propofol for general anesthesia induction and maintenance |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remimazolam based total intravenous anesthesiaFor 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. | Drug | Remimazolam group |
| Propofol based general anesthesiaFor 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. | Drug | propofol group |
Primary outcome
full-scale intelligence quotient
Time frame: one year after surgery
assessed by trained physicians, using the Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition (Chinese Version) 《WPPSI-IV(CN)》
5 secondary outcomes
Memory and learning ability
Time frame: The first to the third year after the operation
Language and Reading Skills
Time frame: The first to the third year after the operation
Executive Function and Attention
Time frame: The first to third year after operation
Behavior and Emotion Assessment
Time frame: The first to third year after surgery
Motor development
Time frame: The first to third years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remimazolam based total intravenous anesthesia and Propofol based general anesthesia in people with Adenotonsillar Hypertrophy, run by The First Affiliated Hospital of Anhui Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
full-scale intelligence quotient (time frame: one year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.