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Use of The Laryngeal Mask Airway Unique for Adenotonsillectomy

We will to compare the safety between the disposable unique laryngeal mask airway and the tracheal tube for adenotonsillectomy in paediatric patients

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611001101976
Enrollment
160
Registered
2011-10-24
Start date
2011-12-01
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Our aim is to compare the disposable LMA and the tracheal tube for adenotonsillectomies. Concerns in respiratory side effects and surgical conditions will be annalise.

Interventions

The patients will be randomised by sealed envelopes. After premedication with oral midazolam the children will be monitored with EKG, peripheral oxygen saturation, non invasive blood pressure. The anesthetic induction will be inhalatory with sevoflurane plus O2/N2O (50%) in a Jackson Rees device and hydratation with Ringer's solution. After propofol 1.5mg.kg and fentanyl 2.0mcg.kg, according the randomization we will to use the disposable Unique LMA, choosing the size and insertion techinique ac

The patients will be randomised by sealed envelopes. After premedication with oral midazolam the children will be monitored with EKG, peripheral oxygen saturation, non invasive blood pressure. The anesthetic induction will be inhalatory with sevoflurane plus O2/N2O (50%) in a Jackson Rees device and hydratation with Ringer's solution. After propofol 1.5mg.kg and fentanyl 2.0mcg.kg, according the randomization we will to use the disposable Unique LMA, choosing the size and insertion techinique according the manufactor's indication or a laryngoscopie with Miller's blade and a paedicatric cuffed tracheal tube, proper to child size . The surgeon will to use the Mc Ivory device to open the mouth and at the end of the surgical procedure, we will perform a tracheoscopy with a apropriated size flexibe fiberscope, to look for blood or secretions. We will analyse the oxygen level at the follow times: 1-after remove the facial mask, 2-after the insertion of the respiratory device (LMA or tracheal tube), 3-after the patient positioning (neck hyperextension), 4- after remove the respiratory device, 5-at admitssion in the recovery room. We will register the occurence of: respiratory adverse events like hypoxia (definied as oxygen saturation bellow 92%), laryngospasm, bronchospasm, cough, and stridor. After 24 hours, by a phone call, we will ask about nausea, vomits and sore throat. The duration of this study will be about 6 hours at the hospital.

Sponsors

Unimed litoral
Lead SponsorOther Collaborative groups

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
1 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

Candidates for adenotonsillectomies, aged 1-12.

Exclusion criteria

Airway active infecction, infection at the tonsils, gastric-oesophageal reflux, signals or history of difficult airway management, coagulation abnormalities.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026