Trials / Completed
CompletedNCT03105739
Timing of Withdrawal of the Laryngeal Mask Airway (LMA) in Children
Timing of Withdrawal of the Laryngeal Mask Airway (LMA) in Children: Early or Late Removal?
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 148 (actual)
- Sponsor
- Hôpital d'enfants Béchir-Hamza · Academic / Other
- Sex
- All
- Age
- 1 Year – 15 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this prospective, randomized study was to compare the incidence of adverse events associated with removal of the LMA either in deeply anesthetised or awake patients.
Detailed description
Written informed consent was obtained from parents for this prospective, randomized study conducted on children scheduled for minor surgery. Anesthesia was induced with sevoflurane, supplemented with propofol (3mg/kg) then maintained with nitrous oxide and sevoflurane 2-4% in oxygen. Analgesia was insured by peripheral nerve blocks. Included children were randomized into 2 groups: * Awake: the LMA was left in place until the patient fully regained consciousness * Deeply anesthetised: the LMA was immediately removed once the halogenated anesthetic turned off, and ventilation using facial mask was carried until spontaneous ventilation recovery. Respiratory complications that occurred during LMA removal until 20 minutes afterwards were recorded. Children with respiratory history and those for whom peripheral nerve blocks failed, were excluded.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | LMA removal | According to randomization, LMA device was removed at the end of surgery, either in deeply anesthetised patients or after consciousness recovery. |
Timeline
- Start date
- 2016-10-05
- Primary completion
- 2017-03-29
- Completion
- 2017-03-30
- First posted
- 2017-04-10
- Last updated
- 2017-04-10
Locations
1 site across 1 country: Tunisia
Source: ClinicalTrials.gov record NCT03105739. Inclusion in this directory is not an endorsement.