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Timing of Withdrawal of the Laryngeal Mask Airway (LMA) in Children

H

Hôpital d'enfants Béchir-Hamza

Status

Completed

Conditions

Laryngeal Mask Airway Removal
Respiratory Complication

Treatments

Other: LMA removal

Study type

Interventional

Funder types

Other

Identifiers

NCT03105739
LMA-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

148 patients

Sex

All

Ages

1 to 15 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Children scheduled for minor surgery

Exclusion criteria

  • None

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

148 participants in 2 patient groups

Anesthetised
Experimental group
Description:
LMA removal once the halogenated anesthetic turned off
Treatment:
Other: LMA removal
Awake
Active Comparator group
Description:
LMA removal once the patient fully regained consciousness
Treatment:
Other: LMA removal

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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