Airway Complications After LMA in Children

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia Recovery
• Intervention / Treatment: Drug: Propofol; Drug: Sevoflurane

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • American University of Beirut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Total intravenous anesthsia; Patients in this group will receive Propofol 5-6 mg/kg and fentanyl 2 µg/kg for induction of anesthesia and propofol 250-300 µg/kg/min for maintenance.	Drug: Propofol; Propofol 5-6 mg/kg and fentanyl 2 µg/kg for induction of anesthesia and propofol 250-300 µg/kg/min for maintenance
Active Comparator: Sevoflurane; Patients in this group will receive sevoflurane 8% and fentanyl 2 µg/kg for induction of anesthesia and sevoflurane 2% for maintenance.	Drug: Sevoflurane; Fentanyl 2 µg/kg for induction of anesthesia and sevoflurane 2% for maintenance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory adverse outcomes	Encountered respiratory adverse outcomes such as cough	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to emergence	Emergence time defined as the time from discontinuation of the anesthetic agents until LMA removal.	2 hours
LMA insertion characteristics	Number of attempts and time taken to insertion, as well as adverse events encountered during insertion.	2 hours
Quality of anesthesia	Lack of movement, bucking, cough	2 hours
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

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2018
• Primary Completion (Actual): May 28, 2021
• Study Completion (Actual): May 28, 2021

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: June 11, 2018
• First Posted (Actual): June 12, 2018

Study Record Updates

• Last Update Posted (Actual): August 24, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Inhalation; Propofol; Sevoflurane
• Other Study ID Numbers: BIO-2017-0276

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No