Airway Complications After LMA in Children

Anesthesia Recovery Clinical Trial

Official title:

The Frequency of Airway Complications After LMA Removal in Children: A Comparison of TIVA and Sevoflurane

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03553082
• Other study ID #: BIO-2017-0276
• Status: Completed
• Phase: N/A
• Start date: May 18, 2018
• Est. completion date: May 28, 2021

Study information

• Verified date: August 2021
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: May 28, 2021
• Est. primary completion date: May 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 6 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anesthesia Recovery

Intervention

Drug:
• Sevoflurane
Fentanyl 2 µg/kg for induction of anesthesia and sevoflurane 2% for maintenance
• Propofol
Propofol 5-6 mg/kg and fentanyl 2 µg/kg for induction of anesthesia and propofol 250-300 µg/kg/min for maintenance

Locations

Country	Name	City	State
Lebanon	American University of Beirut	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory adverse outcomes	Encountered respiratory adverse outcomes such as cough	2 hours
Secondary	Time to emergence	Emergence time defined as the time from discontinuation of the anesthetic agents until LMA removal.	2 hours
Secondary	LMA insertion characteristics	Number of attempts and time taken to insertion, as well as adverse events encountered during insertion.	2 hours
Secondary	Quality of anesthesia	Lack of movement, bucking, cough	2 hours
Secondary	Emergence agitation	4 points scale: 1: calm, 2: not calm but easily consolable, 3: not easily calmed restless or moderately agitated, 4: combative, disoriented or excited.	2 hours