General Anesthesia
Conditions
Brief summary
Children from 6 months to 6 years are randomly allocated into AuraGain group or I-gel group. After anesthetic induction without neuromuscular blocking agent, assigned device in inserted by skillful anesthesiologist. The outcome measures are recorded and analysed.
Interventions
DEVICEAuraGain
After anesthetic induction without neuromuscular blocking agent, AuraGain is inserted.
DEVICEI-gel
After anesthetic induction without neuromuscular blocking agent, I-gel is inserted.
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
6 Months to 6 Years
Healthy volunteers
No
Inclusion criteria
* ASA physical status: 1-3 * age: from 6 months to 6 year * body weight: 5-20kg * patients undergoing upper/lower extremity surgery at supine position
Exclusion criteria
* patients who do not want to participate in this study * patients with known difficult airway including congenital facial anomaly or history of difficult airway management * patients with aspiration risk (gastrointestinal stenosis or stricture) * patients with symptom of upper respiratory infection on the day of surgery * patients scheduled for day surgery * patients judged as not eligible by researchers for other reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| requirement of additional airway maneuver | during placement/maintenance of the device | including adjustment of head/neck position or insertion depth and taping of the device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| success rate | during placement of the device | — |
| ease of gastric tube insertion | within 10 minutes after device insertion | — |
| adverse effect at operating room | during anesthesia | aspiration of gastric fluid, hypoxia, SpO2\<90%, bronchospasm, dental/tongue/lip trauma, staining of blood on the removed device |
| insertion time | during placement of the device | — |
| fiberoptic view of glottis | within 10 minutes after device insertion | Brimacombe score |
| oropharyngeal leak pressure | at 1 minute after device insertion, at 10 minutes after device insertion | — |
| postoperative adverse effect | within postoperative 24 hours | sore throat, hoarseness, airway obstruction |
Countries
South Korea
Outcome results
None listed