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Comparison of remimazolam-based and propofol-based total intravenous anesthesia in Children for postoperative quality of recovery After Tonsillectomy and Adenoidectomy: A randomized non-inferiority trial

The effect of total intravenous anesthesia with remimazolam in children on QoR -15 after tonsillectomy and adenoidectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084851
Enrollment
Unknown
Registered
2024-05-27
Start date
2024-06-04
Completion date
Unknown
Last updated
2025-01-13

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

Conditions

obstructive sleep apnea-hypopnea syndrome

Interventions

remimazolam group :Group R was infused with an induction dose of 0.3 mg/kg of remimazolam at the time of induction and a maintenance dose of 1-3 mg/kg/h.
propofol group:Group P was infused with propofol 3 mg/kg at the time of induction and a maintenance dose of 7.5-10 mg/kg/h.

Sponsors

Shanghai Children’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Years to 15 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria (1) ASA class I-II (2) Age 7-15 years old

Exclusion criteria

Exclusion criteria: (1) Meeting the criteria for postoperative transfer to the pediatric intensive care unit, such as apnea hypopnea index >25, preoperative home oxygen therapy, and airway obstruction during wakefulness (2) Being on sedative or anticonvulsant medications (3) Suffering from psychiatric disorders (4) Comorbidities with severe cardiac, hepatic, and renal dysfunction, and psychiatric anomalies

Design outcomes

Primary

MeasureTime frame
QoR-15 score on postoperative day 1;

Secondary

MeasureTime frame
Hemodynamic data: including pre-induction, immediate post-tracheal intubation, immediate end of anesthesia;Pain in the PACU and on the wards;Complications, including wound infection, hematoma and nerve damage;respiratory recovery time;Extraction time;Preoperative QoR-15 score;

Countries

China

Contacts

Public ContactJiang Yan

Department of Anesthesiology, Shanghai Children’s Hospital

xilingxi@163.com+86 138 1623 7007

Outcome results

None listed

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