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

Not Applicable

Completed

• Conditions: Laryngeal Mask Airway Removal; Respiratory Complication
• Interventions: Other: LMA removal

• Registration Number: NCT03105739
• Lead Sponsor: Hôpital d'enfants Béchir-Hamza

Brief 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.

Study Timeline

• Study Start: 2016-10-05
• Primary Completion: 2017-03-29
• Study First Submitted: 2017-03-29
• Study Completion: 2017-03-30
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-03
• Last Update Submitted: 2017-04-03
• Study First Posted: 2017-04-10
• Last Update Posted: 2017-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

• Children scheduled for minor surgery

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Awake	LMA removal	LMA removal once the patient fully regained consciousness
Anesthetised	LMA removal	LMA removal once the halogenated anesthetic turned off

Primary Outcome Measures

Name	Time	Method
Occurence of respiratory adverse events	from LMA removal to 20 minutes afterwards

Trial Locations

Locations (1)

Hôpital d'Enfants Béchir Hamza; 🇹🇳 Bab Saadoun, Tunis, Tunisia