Airway Complications After LMA in Children

Not Applicable

Completed

• Conditions: Anesthesia Recovery
• Interventions: Drug: Propofol; Drug: Sevoflurane

• Registration Number: NCT03553082
• Lead Sponsor: American University of Beirut Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-08
• Study Start: 2018-05-18
• Study First Submitted QC: 2018-06-11
• Study First Posted: 2018-06-12
• Primary Completion: 2021-05-28
• Study Completion: 2021-05-28
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Total intravenous anesthsia	Propofol	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.
Sevoflurane	Sevoflurane	Patients in this group will receive sevoflurane 8% and fentanyl 2 µg/kg for induction of anesthesia and sevoflurane 2% for maintenance.

Primary Outcome Measures

Name	Time	Method
Respiratory adverse outcomes	2 hours	Encountered respiratory adverse outcomes such as cough

Secondary Outcome Measures

Name	Time	Method
Time to emergence	2 hours	Emergence time defined as the time from discontinuation of the anesthetic agents until LMA removal.
LMA insertion characteristics	2 hours	Number of attempts and time taken to insertion, as well as adverse events encountered during insertion.
Quality of anesthesia	2 hours	Lack of movement, bucking, cough
Emergence agitation	2 hours	4 points scale: 1: calm, 2: not calm but easily consolable, 3: not easily calmed restless or moderately agitated, 4: combative, disoriented or excited.

Trial Locations

Locations (1)

American University of Beirut; 🇱🇧 Beirut, Lebanon