Tongji Hospital
Wuhan, Hubei, 430030, China
Location status: Recruiting
Recruiting
NCT Number: NCT07118579
Effects of Remimazolam and Ciprofol TIVA on PRAE in Pediatric Tonsillectomy and Adenoidectomy
To observe the effects of remimazolam versus ciprofol TIVA on PRAE in pediatric tonsillectomy and adenoidectomy.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
2 year–12 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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)
Exclusion criteria
- 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
Treatment and study plan
Remimazolam
Drugremimazolam induction (0.3-0.5 mg/kg) + maintenance (1-3 mg/kg/h)
Other names: Remi
Propofol
DrugAnesthesia induction (2-3 mg/kg) + Anesthesia maintenance (6-10 mg/kg/h)
Other names: PRO
ciprofol
DrugAnesthesia induction (0.4-0.5 mg/kg) + Anesthesia maintenance (0.8-1.2 mg/kg/h)
Other names: CIP
Primary outcomes
-
The incidence of perioperative respiratory adverse events
Time frame: 5days
The perioperative respiratory adverse events including: laryngospasm, bronchospasm, severe cough, oxygen desaturation, airway obstruction.
Secondary outcomes
-
Anesthesia duration
Time frame: 1 day
From anesthesia induction to discontinuation of anesthetics
-
Emergence time
Time frame: 1 day
From anesthetic discontinuation to eye opening on command
-
Extubation time
Time frame: 1 day
From anesthetic discontinuation to endotracheal tube removal
-
PACU stay duration
Time frame: 1 day
From PACU admission to meeting discharge criteria
-
The modified Aldrete score
Time frame: 1 day
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.
-
doses of drugs
Time frame: 24 hours
Total sedative/analgesic consumption
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Tongji Hospital
Other
Registry information
Official study title
Effects of Remimazolam and Ciprofol Total Intravenous Anesthesia on Perioperative Respiratory Adverse Events in Pediatric Tonsillectomy and Adenoidectomy: A Randomized Controlled Study
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Aug 12, 2025
- Registry last updated
- Nov 21, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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