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

Not Applicable

Not yet recruiting

• Conditions: Tonsillectomy With or Without Adenoidectomy
• Interventions: Drug: Propofol; Drug: Remimazolam; Drug: Ciprofol

• Registration Number: NCT07118579
• Lead Sponsor: Tongji Hospital

Brief Summary

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.

Study Timeline

• Status Verified: 2025-08
• Study Start: 2025-08-01
• Study First Submitted: 2025-08-05
• Study First Submitted QC: 2025-08-05
• Last Update Submitted: 2025-08-05
• Study First Posted: 2025-08-12
• Last Update Posted: 2025-08-12
• Primary Completion: 2025-12
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 114

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol group	Propofol	Anesthesia induction (2-3 mg/kg) + Anesthesia maintenance (6-10 mg/kg/h)
Remimazolam group	Remimazolam	Anesthesia induction (0.3-0.5 mg/kg) + Anesthesia maintenance (1-3 mg/kg/h)
Ciprofol group	Ciprofol	Anesthesia induction (0.4-0.5 mg/kg) + Anesthesia maintenance (0.8-1.2 mg/kg/h)

Primary Outcome Measures

Name	Time	Method
The incidence of perioperative respiratory adverse events	5days	The perioperative respiratory adverse events including: laryngospasm, bronchospasm, severe cough, oxygen desaturation, airway obstruction.

Secondary Outcome Measures

Name	Time	Method
Modified Aldrete score	1 day	Admission to the PACU
Anesthesia duration	1 day	From anesthesia induction to discontinuation of anesthetics
PACU stay duration	1 day	From PACU admission to meeting discharge criteria
Emergence time	1 day	From anesthetic discontinuation to eye opening on command
Extubation time	1 day	From anesthetic discontinuation to endotracheal tube removal
doses of drugs	24 hours	Total sedative/analgesic consumption

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China