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Comparison of Remimazolam and Propofol for Reducing Postoperative Delirium in Pediatric Otolaryngology Surgery: A Randomized Non-Inferiority Trial

Comparison of Remimazolam and Propofol for Reducing Postoperative Delirium in Pediatric Otolaryngology Surgery: A Randomized Non-Inferiority Trial

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098135
Enrollment
Unknown
Registered
2025-03-03
Start date
2025-01-10
Completion date
Unknown
Last updated
2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophy of the tonsils accompanied by adenoid hypertrophy

Interventions

Remimazolam group (R):Remimazolam tosilate 0.1mg/kg was administered at the end of operation
Propofol group (P):Propofol 1mg/kg was administered at the end of surgery

Sponsors

Affiliated Hospital of North Sichuan Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 7 Years

Inclusion criteria

Inclusion criteria: 1. Age: 3-7 years old 2. American Society of Anesthesiologists (ASA) grade ? or ?; 3. Patients undergoing elective tonsillectomy or adenoidectomy;

Exclusion criteria

Exclusion criteria: 1. Children with liver and kidney dysfunction, cardiovascular dysfunction, endocrine dysfunction, or other organ dysfunction (ASA Class III or IV) 2. Allergy or hypersensitivity to remimazolam; 3. Mental disorders; 4. Recent respiratory tract infection (2 weeks); 5. Other reasons for not participating in the trial in the opinion of the investigator: being in professional care or living in a social welfare institution or any other factors that may affect their ability to participate in the study.

Design outcomes

Primary

MeasureTime frame
Incidence of delirium during the recovery period;

Secondary

MeasureTime frame
FLACC Scale;Post-hospital Behavior questionnaire;Anesthesia recovery indicators;Modified Aldrete Score;Duration of surgery;Duration of anesthesia;Time to extubation;Time to recovery;Incidence of rescue propofol or fentanyl in PACU;Systolic Blood Pressure;Diastolic blood pressure;Mean arterial pressure;Heartrate;The occurrence of adverse events within 48 h postoperatively;Parents' satisfaction (Numerical scoring method);

Countries

China

Contacts

Public ContactYong Pang

Department of Anesthesiology, Affiliated Hospital of North Sichuan Medical College

7821602@qq.com+86 158 0817 9936

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026