Perioperative Airway-Related Complications
Conditions
Interventions
Experimental group:All subjects who meet the inclusion criteria will receive one 4mg dose of Montelukast Sodium Orally Disintegrating Film intervention at 24 hours (-24h) and 2 hours (-2h) prior to th
Sponsors
The First Affiliated Hospital of Bengbu Medical College
Eligibility
Sex/Gender
All
Age
3 Years to 6 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 3-6 years old (>=3 years old =5 cigarettes/day in the household); (4) obesity (BMI> = 95th percentile of the same age and gender); 4. One of the following conditions must be met: (1) Previous use of inhaled glucocorticoids (such as budesonide) for the prevention of perioperative complications was ineffective (definition: moderate to severe airway-related events occurred within 24 hours after surgery>=1 time); (2) Intolerance to inhaled glucocorticoids (such as inducing laryngospasm, severe choking cough); (3) Contraindications to inhaled glucocorticoids (such as severe adverse reactions induced by glucocorticoids in the past); 5. American Society of Anesthesiologists (ASA) grade: I-II; 6. Guardians sign informed consent: voluntarily participate and complete follow-up.
Exclusion criteria
Exclusion criteria: 1. Contraindications to montelukast sodium: (1) Known allergy to montelukast sodium or preparation excipients; (2) Phenylketonuria (orally lysing membrane containing aspartame); 2. No guideline-recommended treatment (inhaled glucocorticoids) unless there are clear contraindications; 3. History of neurological and psychiatric disorders: (1) Confirmed epilepsy, autism spectrum disorder, attention deficit hyperactivity disorder; (2) Psychiatric and neurological events with previous use of montelukast sodium; (3) family history of mental illness; 4. Respiratory system: (1) Acute respiratory infection (with fever, pus, wet cough); (2) Acute asthma attack (systemic glucocorticoid therapy is required in the past 4 weeks); (3) Active tuberculosis, bronchopulmonary dysplasia; 5. Vital organ dysfunction: (1) Abnormal liver enzymes (ALT/AST > 1.5 times the upper limit of normal value); (2) renal insufficiency (creatinine > upper limit of normal value for the same age); 6. Drug Interactions: (1) Are using strong inducers of CYP3A4/CYP2C8 (such as rifampicin, phenytoin) or inhibitors (such as gemfibrozil); (2) Systemic glucocorticoid therapy is required before surgery; 7. Other exclusion factors: (1) Mechanical ventilation of endotracheal intubation is planned within 48 hours after surgery; (2) Other situations judged by the investigator to be unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence rate of composite complications within 24 hours postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of specific complications independently;Subgroup efficacy difference analysis;Exploratory pharmacokinetic (PK) analysis;Pharmacodynamic (PD) analysis; | — |
Countries
China
Contacts
Public ContactYang Zhang
The First Affiliated Hospital of Bengbu Medical College
Outcome results
None listed