Effects of Remimazolam and Ciprofol TIVA on PRAE in Pediatric Tonsillectomy and Adenoidectomy
NCT ID: NCT07118579
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
114 participants
INTERVENTIONAL
2025-09-23
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Propofol group
Anesthesia induction (2-3 mg/kg) + Anesthesia maintenance (6-10 mg/kg/h)
Propofol
Anesthesia induction (2-3 mg/kg) + Anesthesia maintenance (6-10 mg/kg/h)
Remimazolam group
Anesthesia induction (0.3-0.5 mg/kg) + Anesthesia maintenance (1-3 mg/kg/h)
Remimazolam
remimazolam induction (0.3-0.5 mg/kg) + maintenance (1-3 mg/kg/h)
Ciprofol group
Anesthesia induction (0.4-0.5 mg/kg) + Anesthesia maintenance (0.8-1.2 mg/kg/h)
Ciprofol
Anesthesia induction (0.4-0.5 mg/kg) + Anesthesia maintenance (0.8-1.2 mg/kg/h)
Interventions
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Remimazolam
remimazolam induction (0.3-0.5 mg/kg) + maintenance (1-3 mg/kg/h)
Propofol
Anesthesia induction (2-3 mg/kg) + Anesthesia maintenance (6-10 mg/kg/h)
Ciprofol
Anesthesia induction (0.4-0.5 mg/kg) + Anesthesia maintenance (0.8-1.2 mg/kg/h)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
2 Years
12 Years
ALL
No
Sponsors
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Tongji Hospital
OTHER
Responsible Party
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aijun xu
Professor
Principal Investigators
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Mujun Chang
Role: STUDY_DIRECTOR
Tongji Hospital
Locations
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Tongji Hospital
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RCTIVA
Identifier Type: -
Identifier Source: org_study_id
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