Condition 1: Hypertrophy of tonsils. Condition 2: Hypertrophy of adenoids. Condition 3: Hypertrophy of tonsils with hypertrophy of adenoids. Condition 4: Other chronic diseases of tonsils and adenoids. Condition 5: Laryngeal spasm. Hypertrophy of tonsils Hypertrophy of adenoids Hypertrophy of tonsils with hypertrophy of adenoids Other chronic diseases of tonsils and adenoids Laryngeal spasm
Conditions
Interventions
Intervention 1: Intervention group: Participants in this group receive intravenous propofol at a subhypnotic dose of 0.5 mg/kg. The drug is injected as a slow bolus over 10 to 20 seconds and exactly 6
Sponsors
Karaj University of Medical Sciences
Eligibility
Sex/Gender
All
Age
3 Years to 12 Years
Inclusion criteria
Inclusion criteria: Children aged 3 to 12 years who are candidates for tonsillectomy with or without adenoidectomy. Physical status ASA Class I or II. Ability to obtain informed consent from parents or legal guardians. No allergy or contraindication to propofol and its formulation components (such as eggs and soy).
Exclusion criteria
Exclusion criteria: Active or recent upper airway infection (within the past two weeks). History of uncontrolled asthma or active bronchospasm. History of airway difficulty or predicted difficulty in intubation. Children with confirmed severe OSA or severe respiratory illness. History of severe allergic reaction (anaphylaxis) to propofol or similar drugs. Presence of neurological disease or severe developmental delay that would impair the child's response to the extubation protocol. Unexpected complications during surgery that would prevent the implementation of the standard extubation protocol. Presence of severe systemic disease (cardiac, renal, or hepatic).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-extubation laryngospasm. Timepoint: Within the first 2 minutes after extubation in the operating room. Method of measurement: Direct clinical observation based on standard criteria of airway obstruction (stridor, ineffective respiratory effort, oxygen desaturation).;Severity of laryngospasm. Timepoint: At the time of laryngospasm occurrence within the first 2 minutes after extubation. Method of measurement: Four-point Laryngospasm Severity Scale (0=none; 1=mild; 2=moderate; 3=severe requiring pharmacologic intervention or re-intubation). | — |
Secondary
| Measure | Time frame |
|---|---|
| Coughing after extubation. Timepoint: Presence and severity of cough within 2 minutes after extubation based on a 0–3 scale (0=none, 1=single cough, 2=less than 5 seconds, 3=more than 5 seconds). Method of measurement: Based on a scale of 0–3 (0=none, 1=single cough, 2=less than 5 seconds, 3=more than 5 seconds). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMaryam Mardani Hosseinabadi
Karaj University of Medical Sciences
Outcome results
None listed