NCT03105739

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2017

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 10, 2017

Completed
Last Updated

April 10, 2017

Status Verified

April 1, 2017

Enrollment Period

6 months

First QC Date

March 29, 2017

Last Update Submit

April 3, 2017

Conditions

Laryngeal Mask Airway RemovalRespiratory Complication

Outcome Measures

Primary Outcomes (1)

  • Occurence of respiratory adverse events

    from LMA removal to 20 minutes afterwards

Study Arms (2)

Anesthetised

EXPERIMENTAL

LMA removal once the halogenated anesthetic turned off

Other: LMA removal

Awake

ACTIVE COMPARATOR

LMA removal once the patient fully regained consciousness

Other: LMA removal

Interventions

LMA removalOTHER

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

AnesthetisedAwake

Eligibility Criteria

Age1 Year - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children scheduled for minor surgery

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital d'Enfants Béchir Hamza

Bab Saadoun, Tunis Governorate, 1029, Tunisia

Location

Study Officials

  • Sonia Ben Khalifa, PhD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Anesthesia and Intensive Care Department

Study Record Dates

First Submitted

March 29, 2017

First Posted

April 10, 2017

Study Start

October 5, 2016

Primary Completion

March 29, 2017

Study Completion

March 30, 2017

Last Updated

April 10, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)