Tonsillectomy With or Without AdenoidectomyPhase 4NCT07118579
Effects of Remimazolam and Ciprofol TIVA on PRAE in Pediatric Tonsillectomy and Adenoidectomy
A Phase 4 study testing Remimazolam, Propofol and Ciprofol in people with Tonsillectomy With or Without Adenoidectomy, run by Tongji Hospital at 1 site in China.
Trial summary
To observe the effects of remimazolam versus ciprofol TIVA on PRAE in pediatric tonsillectomy and adenoidectomy. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Tonsillectomy With or Without Adenoidectomy
- What is being tested?
- Remimazolam, Propofol and Ciprofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteChina
- Study dates
- 23 Sep 2025to Aug 2026
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 2-12 years
- ASA physical status I-II
- Body mass index (BMI): 14-28 kg/m²
- Scheduled for elective tonsillectomy with or without adenoidectomy
- Signed informed consent by legal guardian(s) and assent by children (≥8 years old)
Who cannot join
- History of severe pulmonary diseases (e.g., asthma, bronchiectasis, severe OSA)
- Previous episodes of significant PRAEs
- Documented drug allergies (e.g., to remimazolam, propofol, or ciprofol)
- Comorbidities including: Uncorrected congenital heart disease, neuromuscular disorders, Developmental delay, Abnormal hepatic/renal function
- Preoperative moderate-to-severe respiratory infections requiring surgery postponement
- Recent participation in other clinical trials
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430030
Pu Zhou, 02783663625, tongjihlunli@163.com
About this study
Official title: Effects of Remimazolam and Ciprofol Total Intravenous Anesthesia on Perioperative Respiratory Adverse Events in Pediatric Tonsillectomy and Adenoidectomy: A Randomized Controlled Study
To observe the effects of remimazolam versus ciprofol TIVA on PRAE in pediatric tonsillectomy and adenoidectomy.
Read the detailed description
To observe the effects of remimazolam versus ciprofol TIVA on PRAE in pediatric tonsillectomy and adenoidectomy, aiming to enhance surgical safety and improve postoperative outcomes in pediatric patients.
- Being tested
- Remimazolam, Propofol, Ciprofol
- Keywords
- Remimazolam, Ciprofol, TIVA, PRAE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Also called Remi
remimazolam induction (0.3-0.5 mg/kg) + maintenance (1-3 mg/kg/h)
PropofolDrug
Also called PRO
Anesthesia induction (2-3 mg/kg) + Anesthesia maintenance (6-10 mg/kg/h)
CiprofolDrug
Also called CIP
Anesthesia induction (0.4-0.5 mg/kg) + Anesthesia maintenance (0.8-1.2 mg/kg/h)
| Study group | Role | What they receive |
|---|---|---|
| Propofol group | Active comparator | Anesthesia induction (2-3 mg/kg) + Anesthesia maintenance (6-10 mg/kg/h) Receives: Drug: Propofol |
| Remimazolam group | Experimental | Anesthesia induction (0.3-0.5 mg/kg) + Anesthesia maintenance (1-3 mg/kg/h) Receives: Drug: Remimazolam |
| Ciprofol group | Experimental | Anesthesia induction (0.4-0.5 mg/kg) + Anesthesia maintenance (0.8-1.2 mg/kg/h) Receives: Drug: Ciprofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of perioperative respiratory adverse events
The perioperative respiratory adverse events including: laryngospasm, bronchospasm, severe cough, oxygen desaturation, airway obstruction.
Measured: 5days
Secondary outcomes (6)
Anesthesia duration
From anesthesia induction to discontinuation of anesthetics
Measured: 1 day
Emergence time
From anesthetic discontinuation to eye opening on command
Measured: 1 day
Extubation time
From anesthetic discontinuation to endotracheal tube removal
Measured: 1 day
PACU stay duration
From PACU admission to meeting discharge criteria
Measured: 1 day
The modified Aldrete score
Upon admission to the PACU, the child was assessed using the modified Aldrete score, which ranges from 0 to 10. A higher score indicates a better recovery status.
Measured: 1 day
doses of drugs
Total sedative/analgesic consumption
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start23 Sep 2025
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tonsillectomy With or Without AdenoidectomyStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aijun xu, Tongji Hospital
- Investigators
- Mujun Chang, Study director, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118579
- Sponsor's protocol ID
- RCTIVA
- Status last verified
- Nov 2025
- First submitted
- 5 Aug 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Remimazolam and Ciprofol Total Intravenous Anesthesia on Perioperative Respiratory Adverse Events in Pediatric Tonsillectomy and Adenoidectomy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07118579
- Acronym / sponsor ID
- RCTIVA
- Keywords
- Remimazolam, Ciprofol, TIVA, PRAE
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 23 Sep 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 12 Aug 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.
To observe the effects of remimazolam versus ciprofol TIVA on PRAE in pediatric tonsillectomy and adenoidectomy.
Detailed description
To observe the effects of remimazolam versus ciprofol TIVA on PRAE in pediatric tonsillectomy and adenoidectomy, aiming to enhance surgical safety and improve postoperative outcomes in pediatric patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Propofol group | Active comparator | Drug: PropofolAnesthesia induction (2-3 mg/kg) + Anesthesia maintenance (6-10 mg/kg/h) |
| Remimazolam group | Experimental | Drug: RemimazolamAnesthesia induction (0.3-0.5 mg/kg) + Anesthesia maintenance (1-3 mg/kg/h) |
| Ciprofol group | Experimental | Drug: CiprofolAnesthesia induction (0.4-0.5 mg/kg) + Anesthesia maintenance (0.8-1.2 mg/kg/h) |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Aged 2-12 years
- ASA physical status I-II
- Body mass index (BMI): 14-28 kg/m²
- Scheduled for elective tonsillectomy with or without adenoidectomy
- Signed informed consent by legal guardian(s) and assent by children (≥8 years old)
Key exclusion criteria (6 listed)
- History of severe pulmonary diseases (e.g., asthma, bronchiectasis, severe OSA)
- Previous episodes of significant PRAEs
- Documented drug allergies (e.g., to remimazolam, propofol, or ciprofol)
- Comorbidities including: Uncorrected congenital heart disease, neuromuscular disorders, Developmental delay, Abnormal hepatic/renal function
- Preoperative moderate-to-severe respiratory infections requiring surgery postponement
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 |
|---|---|---|
| RemimazolamAlso: Remiremimazolam induction (0.3-0.5 mg/kg) + maintenance (1-3 mg/kg/h) | Drug | Remimazolam group |
| PropofolAlso: PROAnesthesia induction (2-3 mg/kg) + Anesthesia maintenance (6-10 mg/kg/h) | Drug | Propofol group |
| CiprofolAlso: CIPAnesthesia induction (0.4-0.5 mg/kg) + Anesthesia maintenance (0.8-1.2 mg/kg/h) | Drug | Ciprofol group |
Primary outcome
The incidence of perioperative respiratory adverse events
Time frame: 5days
The perioperative respiratory adverse events including: laryngospasm, bronchospasm, severe cough, oxygen desaturation, airway obstruction.
6 secondary outcomes
Anesthesia duration
Time frame: 1 day
Emergence time
Time frame: 1 day
Extubation time
Time frame: 1 day
PACU stay duration
Time frame: 1 day
The modified Aldrete score
Time frame: 1 day
doses of drugs
Time frame: 24 hours
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 21 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Mujun Chang study director
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remimazolam, Propofol and Ciprofol in people with Tonsillectomy With or Without Adenoidectomy, run by Tongji Hospital at 1 site in China.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Pu Zhou (02783663625, tongjihlunli@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of perioperative respiratory adverse events (time frame: 5days). 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 21 Nov 2025.