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Association of age as risk factor for airway complication after tonsillectomy (with/without adenoidectomy) in children

Association of age as risk factor for airway complication after tonsillectomy (with/without adenoidectomy) in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059421
Enrollment
Unknown
Registered
2022-04-29
Start date
2022-05-01
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Respiratory system complications in patients undergoing tonsillectomy and/or adenoidectomy

Interventions

Group A:Sufentanil 0.1 ug/kg
Group B:Sufentanil 0.2 ug/kg
Group C:Sufentanil 0.25 ug/kg
Group D:Sufentanil 0.3 ug/kg

Sponsors

Yichang Central People's Hospital of Hubei Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age: 3-65 years old; 2. ASA I or II level; 3. The estimated time of anesthetic operation is <= 120 min; 4. BMI 14-23.9 kg/m2.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of opioid allergy; 2. Analgesic, sedative, antiemetic and antipruritic drugs were used 24 hours before operation; 3. Patients with body temperature higher than 38°C or symptoms of acute upper respiratory infection within 24 hours before operation; 4. Patients with a history of bronchial asthma; 5. Patients diagnosed with moderate to severe sleep apnea syndrome before surgery; 6. Patients with difficult airway or previous history of abnormal anesthesia recovery after preoperative assessment; 7. Renal impairment (BUN and or Cr > upper limit of normal value); 8. Liver dysfunction (ALT and or AST > 1.5 times the upper limit of normal value); 9. Patients with a history of severe head trauma and intracranial hypertension within 6 months; 10. Patients with mental or neurological diseases, or patients who cannot express their wishes correctly; 11. Patients with a history of taking long-term sedative and analgesic drugs or monoamine oxidase inhibitors; 12. Estimated surgical blood loss is greater than 100 mL; 13. Those who have participated in other drug clinical trials in the past month; 14. Patients who cannot perform ASA or FLACC scoring due to various reasons; 15. With other conditions, the investigator believes that the patients are not suitable for inclusion; 16. Abnormal breath-hold test; 17. Has not quit smoking within half a month; 18. Patients with high blood pressure or those with arrhythmia.

Design outcomes

Primary

MeasureTime frame
Sufentanil induced cough times;Extubation coughing times;Sore throat score after surgery;Extubation time;Number of cases of additional drug use;Vas pain score within 24 hours;Number of cases of postoperative nausea and vomiting;

Secondary

MeasureTime frame
Hemodynamic parameters within five minutes after induction of intubation;Hemodynamic indexes within five minutes after extubation;

Countries

China

Contacts

Public ContactGong Yuan

Yichang Central People's Hospital of Hubei Province

gy-yc@163.com+86 13986746821

Outcome results

None listed

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