Clinical Trials Directory

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

TypeNameDescription
OTHERLMA removalAccording 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.