Effects of Remimazolam and Ciprofol TIVA on PRAE in Pediatric Tonsillectomy and Adenoidectomy
1 other identifier
interventional
114
1 country
1
Brief Summary
To observe the effects of remimazolam versus ciprofol TIVA on PRAE in pediatric tonsillectomy and adenoidectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2025
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2025
CompletedFirst Posted
Study publicly available on registry
August 12, 2025
CompletedStudy Start
First participant enrolled
September 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
November 21, 2025
November 1, 2025
10 months
August 5, 2025
November 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The incidence of perioperative respiratory adverse events
The perioperative respiratory adverse events including: laryngospasm, bronchospasm, severe cough, oxygen desaturation, airway obstruction.
5days
Secondary Outcomes (6)
Anesthesia duration
1 day
Emergence time
1 day
Extubation time
1 day
PACU stay duration
1 day
The modified Aldrete score
1 day
- +1 more secondary outcomes
Study Arms (3)
Propofol group
ACTIVE COMPARATORAnesthesia induction (2-3 mg/kg) + Anesthesia maintenance (6-10 mg/kg/h)
Remimazolam group
EXPERIMENTALAnesthesia induction (0.3-0.5 mg/kg) + Anesthesia maintenance (1-3 mg/kg/h)
Ciprofol group
EXPERIMENTALAnesthesia induction (0.4-0.5 mg/kg) + Anesthesia maintenance (0.8-1.2 mg/kg/h)
Interventions
remimazolam induction (0.3-0.5 mg/kg) + maintenance (1-3 mg/kg/h)
Anesthesia induction (2-3 mg/kg) + Anesthesia maintenance (6-10 mg/kg/h)
Anesthesia induction (0.4-0.5 mg/kg) + Anesthesia maintenance (0.8-1.2 mg/kg/h)
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tongji Hospitallead
Study Sites (1)
Tongji Hospital
Wuhan, Hubei, 430030, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mujun Chang
Tongji Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 5, 2025
First Posted
August 12, 2025
Study Start
September 23, 2025
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
November 21, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share