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Recruiting NCT07118579

Effects of Remimazolam and Ciprofol TIVA on PRAE in Pediatric Tonsillectomy and Adenoidectomy

Phase IV Interventional Tonsillectomy With or Without Adenoidectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Remimazolam, Propofol, Ciprofol.
Who it may be relevant to
Registry conditions: Tonsillectomy With or Without Adenoidectomy. Basic parameters: 2 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effects of Remimazolam and Ciprofol Total Intravenous Anesthesia on Perioperative Respiratory Adverse Events in Pediatric Tonsillectomy and Adenoidectomy: A Randomized Controlled Study

Overview

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.

Interventions

  • Drug Remimazolam
    remimazolam induction (0.3-0.5 mg/kg) + maintenance (1-3 mg/kg/h)
  • Drug Propofol
    Anesthesia induction (2-3 mg/kg) + Anesthesia maintenance (6-10 mg/kg/h)
  • Drug Ciprofol
    Anesthesia induction (0.4-0.5 mg/kg) + Anesthesia maintenance (0.8-1.2 mg/kg/h)

Primary outcome measures

  • The incidence of perioperative respiratory adverse events [Time frame: 5days]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

China · 1 center
  • Tongji Hospital — Wuhan

Identifiers

NCT: NCT07118579 · RCTIVA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗