Airway Complications After LMA in Children

NCT03553082 | Completed

• 1 other identifier: BIO-2017-0276
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia Recovery

Outcome Measures

Primary Outcomes (1)

• Respiratory adverse outcomes

  Encountered respiratory adverse outcomes such as cough

  2 hours

Secondary Outcomes (4)

• Time to emergence

  2 hours

• LMA insertion characteristics

  2 hours

• Quality of anesthesia

  2 hours

• Emergence agitation

  2 hours

Study Arms (2)

Total intravenous anesthsia

ACTIVE COMPARATOR

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

Sevoflurane

ACTIVE COMPARATOR

Patients in this group will receive sevoflurane 8% and fentanyl 2 µg/kg for induction of anesthesia and sevoflurane 2% for maintenance.

Drug: Sevoflurane

Interventions

Sevoflurane DRUG

Fentanyl 2 µg/kg for induction of anesthesia and sevoflurane 2% for maintenance

Sevoflurane

Propofol DRUG

Propofol 5-6 mg/kg and fentanyl 2 µg/kg for induction of anesthesia and propofol 250-300 µg/kg/min for maintenance

Total intravenous anesthsia

Eligibility Criteria

• Age: 6 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Age: more than 6 years old and less than 6 months
• Patients having: Asthma, hyper reactive airway (Acute exacerbation)
• Patients having recent respiratory tract infection within 2 weeks.
• Patients with congenital heart disease
• 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)
• Patients at high risk of aspiration
• Anticipated difficult airway
• Patient with neurologic disorders (children with known neurologic disorders: seizure, mental retardation, cerebral palsy)
• Difficult LMA insertion (\> 3 attempts)

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut

Beirut, Lebanon

Location

Related Publications (1)

• Karam C, Zeeni C, Yazbeck-Karam V, Shebbo FM, Khalili A, Abi Raad SG, Beresian J, Aouad MT, Kaddoum R. Respiratory Adverse Events After LMA(R) Mask Removal in Children: A Randomized Trial Comparing Propofol to Sevoflurane. Anesth Analg. 2023 Jan 1;136(1):25-33. doi: 10.1213/ANE.0000000000005945. Epub 2022 Feb 25.

  PMID: 35213484 DERIVED

MeSH Terms

Interventions

Sevoflurane; Propofol

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of clinical Anesthesiology

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: June 12, 2018
• Study Start: May 18, 2018
• Primary Completion: May 28, 2021
• Study Completion: May 28, 2021
• Last Updated: August 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)