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Effect of alfentanil on rapid perioperative recovery of tonsillectomy and adenoidectomy in children: a randomized, double-blind clinical trial

Effect of alfentanil on rapid perioperative recovery of tonsillectomy and adenoidectomy in children: a randomized, double-blind clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300073844
Enrollment
Unknown
Registered
2023-07-24
Start date
2023-07-24
Completion date
Unknown
Last updated
2023-07-30

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

Conditions

Hyperplasia of tonsils and adenoids in children

Interventions

Control group:Fentanyl 4 µg/kg group (C group)
Experimental group:Affentanil 20 µg/kg groups (E1 group)
Experimental group:Affentanil 30µg/kg groups ( E2 group)
Experimental group:Affentanil 40µg/kg groups ( E3 group)

Sponsors

Yijishan Hospital of Wannan Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 10 Years

Inclusion criteria

Inclusion criteria: 1) Age 5-10 years old, gender is not limited; 2) Weight between 14-28kg; 3) The ASA score is I or II; 4) Patients with complete clinical data who intend to undergo tonsillectomy or adenoidectomy; 5) Clearly understand and voluntarily participate in the study, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Children with mental illness; 2) Children with congenital heart disease, liver and kidney dysfunction; 3) Children with respiratory diseases such as asthma; 4) Children with special constitutions, children with allergies, and those with a history of malignant hyperthermia in the family;

Design outcomes

Primary

MeasureTime frame
mean arterial pressure, MAP;heart rate, HR;SpO2;Airway pressure;PAED score;FLACC score;Duration of surgery, time to anesthesia, time to extubation (time to stop propofol and refentanil pumping to time to remove the catheter), time to wake up, time to stay in the PACU;PAB score;Alderete score;

Secondary

MeasureTime frame
Use of propofol, refentanil, cis-atracurium, and other adjunctive medications;Conditions with medications such as analgesia or antiemetics;The number of occurrences of bradycardia, hypoxemia, hypotension, hypertension, airway spasm, increased airway pressure, choking, nausea and vomiting was recorded;

Countries

Chian

Contacts

Public ContactYongquan Chen

Yijishan Hospital of Wannan Medical College

chenyq263@163.com+86 139 5619 6920

Outcome results

None listed

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