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

NCT ID: NCT03105739

Last Updated: 2017-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-05
• Study Completion Date: 2017-03-30

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.

Conditions

Laryngeal Mask Airway Removal; Respiratory Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Anesthetised

LMA removal once the halogenated anesthetic turned off

Group Type: EXPERIMENTAL

LMA removal

Intervention Type: OTHER

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

Awake

LMA removal once the patient fully regained consciousness

Group Type: ACTIVE_COMPARATOR

LMA removal

Intervention Type: OTHER

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

Interventions

LMA removal

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Children scheduled for minor surgery

Exclusion Criteria

• None

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital d'enfants Béchir-Hamza

OTHER

Sponsor Role: lead

Responsible Party

Dr Sonia ben khalifa (PhD)

Head of Anesthesia and Intensive Care Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sonia Ben Khalifa, PhD

Role: PRINCIPAL_INVESTIGATOR

Locations

Hôpital d'Enfants Béchir Hamza

Bab Saadoun, Tunis Governorate, Tunisia

Countries

Tunisia

Other Identifiers

LMA-001

Identifier Type: -

Identifier Source: org_study_id