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OpenTrials
Completed

NCT Number: NCT03553082

Airway Complications After LMA in Children

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.

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Key information

Conditions

Age range

6 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

American University of Beirut

Beirut, Lebanon

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Sevoflurane

Drug

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

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

Primary outcomes

  1. Respiratory adverse outcomes

    Time frame: 2 hours

    Encountered respiratory adverse outcomes such as cough

Secondary outcomes

  1. Time to emergence

    Time frame: 2 hours

    Emergence time defined as the time from discontinuation of the anesthetic agents until LMA removal.

  2. LMA insertion characteristics

    Time frame: 2 hours

    Number of attempts and time taken to insertion, as well as adverse events encountered during insertion.

  3. Quality of anesthesia

    Time frame: 2 hours

    Lack of movement, bucking, cough

  4. Emergence agitation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

American University of Beirut Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 12, 2018
Registry last updated
Aug 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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