Clinical trial NCT03553082: Airway Complications After LMA in Children
Official title: The Frequency of Airway Complications After LMA Removal in Children: A Comparison of TIVA and Sevoflurane
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia Recovery
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 135
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background: The removal of Laryngeal Mask Airway (LMA) in children may be associated with respiratory adverse events. The incidence of these adverse events may be influenced by the type of anesthesia maintenance. It is not clear whether Total Intravenous Anesthesia (TIVA) with propofol is associated with a lower incidence of respiratory events upon removal of LMA as compared to maintenance with sevoflurane.

Specific Aim: The primary aim of this study is to compare the prevalence of respiratory adverse events following LMA removal in patient receiving TIVA versus sevoflurane inhalational anesthesia in a pediatric population aged between 6 month and 6 years old. Secondary outcomes include quality of induction, maintenance and emergence from anesthesia between the 2 groups as evidenced by ease of LMA insertion, absence of bucking or movement during the procedure, time to LMA removal, and absence of emergence agitation.

Methods: In this prospective randomized clinical trial, children will be enrolled in one of two groups: Group 1 will receive propofol for induction and maintenance of anesthesia, Group 2 will receive sevoflurane for induction and maintenance of anesthesia. In both groups patients will be mechanically ventilated. At the end of the procedure, LMAs will be removed when patients are fully awake as defined by the return of reflexes, eye opening, and purposeful movements.

Significance: Data comparing the influence of TIVA and sevoflurane on the occurrence of respiratory adverse events after LMA removal are limited. Both techniques are standard of care at our institution. However, as per our clinical observations, we hypothesize that TIVA is superior to sevoflurane. This study will identify the technique that provides optimal anesthetic conditions and improved patient's safety.


Eligibility criteria: Inclusion Criteria:

1. Age: 6 months to 6 years old
2. Patients undergoing short duration procedure ( ˂ 2 hours) (such as polysite removal, closed reduction, eye examination, excluding thoracic and abdominal surgery)
3. American Society of Anesthesiologists (ASA): I-III
4. Patients undergoing LMA general anesthesia. (NPO, short procedures, patient without known airway abnormalities).
5. Parental consent

Exclusion Criteria:

1. Age: more than 6 years old and less than 6 months
2. Patients having: Asthma, hyper reactive airway (Acute exacerbation)
3. Patients having recent respiratory tract infection within 2 weeks.
4. Patients with congenital heart disease
5. Patients not eligible for LMA (full stomach, hiatal hernia, known or predicted difficult airway, syndromic patient with facial or airway malformation, patient undergoing major abdominal or thoracic surgery)
6. Patients at high risk of aspiration
7. Anticipated difficult airway
8. Patient with neurologic disorders (children with known neurologic disorders: seizure, mental retardation, cerebral palsy)
9. Difficult LMA insertion (\> 3 attempts)

Primary outcomes:
measure: Respiratory adverse outcomes
timeFrame: 2 hours
Secondary outcomes:
measure: Time to emergence
timeFrame: 2 hours
measure: LMA insertion characteristics
timeFrame: 2 hours
measure: Quality of anesthesia
timeFrame: 2 hours
measure: Emergence agitation
timeFrame: 2 hours
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut
Study officials:
References: