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

Tongji Hospital

Status and phase: Enrolling; Phase 4

Conditions: Tonsillectomy With or Without Adenoidectomy

Treatments: Drug: Propofol; Drug: Remimazolam; Drug: Ciprofol

Study type: Interventional

Funder types: Other

Identifiers

NCT07118579

RCTIVA

Details and patient eligibility

About

To observe the effects of remimazolam versus ciprofol TIVA on PRAE in pediatric tonsillectomy and adenoidectomy.

Full 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.

Enrollment: 114 estimated patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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114 participants in 3 patient groups

Propofol group

Active Comparator group

Description:

Anesthesia induction (2-3 mg/kg) + Anesthesia maintenance (6-10 mg/kg/h)

Treatment:

Drug: Propofol

Remimazolam group

Experimental group

Description:

Anesthesia induction (0.3-0.5 mg/kg) + Anesthesia maintenance (1-3 mg/kg/h)

Treatment:

Drug: Remimazolam

Ciprofol group

Experimental group

Description:

Anesthesia induction (0.4-0.5 mg/kg) + Anesthesia maintenance (0.8-1.2 mg/kg/h)

Treatment:

Drug: Ciprofol