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NCT03105739 Clinical Trial

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

Respiratory Complication Clinical Trial

Official title:
Timing of Withdrawal of the Laryngeal Mask Airway (LMA) in Children: Early or Late Removal?

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03105739
Other study ID # LMA-001
Secondary ID
Status Completed
Phase N/A
First received March 29, 2017
Last updated April 3, 2017
Start date October 5, 2016
Est. completion date March 30, 2017

Study information
Verified date April 2017
Source Hôpital d'enfants Béchir-Hamza
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 148
Est. completion date March 30, 2017
Est. primary completion date March 29, 2017
Accepts healthy volunteers No
Gender All
Age group 1 Year to 15 Years
Eligibility Inclusion Criteria:

- Children scheduled for minor surgery

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• LMA removal
According to randomization, LMA device was removed at the end of surgery, either in deeply anesthetised patients or after consciousness recovery.

Locations
Country Name City State
Tunisia Hôpital d'Enfants Béchir Hamza Bab Saadoun Tunis

Sponsors (1)
Lead Sponsor Collaborator
Hôpital d'enfants Béchir-Hamza

Country where clinical trial is conducted

Tunisia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Occurence of respiratory adverse events from LMA removal to 20 minutes afterwards
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