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Airway Complications After LMA in Children

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ClinicalTrials.gov Identifier: NCT03553082
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
Jean berezian, 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.


Condition or disease Intervention/treatment Phase
Anesthesia Recovery Drug: Sevoflurane Drug: Propofol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: The Frequency of Airway Complications After LMA Removal in Children: A Comparison of TIVA and Sevoflurane
Actual Study Start Date : May 18, 2018
Estimated Primary Completion Date : December 4, 2019
Estimated Study Completion Date : December 4, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Respiratory adverse outcomes [ Time Frame: 2 hours ]
    Encountered respiratory adverse outcomes such as cough


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   6 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553082


Contacts
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Contact: Marie Aouad, MD 01350000 ext 6380 mm01@aub.edu.lb

Locations
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Lebanon
American University of Beirut Recruiting
Beirut, Lebanon
Contact: Marie Aouad, MD    9613761702    mm01@aub.edu.lb   
Sponsors and Collaborators
American University of Beirut Medical Center

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Responsible Party: Jean berezian, Instructor of clinical Anesthesiology, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT03553082     History of Changes
Other Study ID Numbers: BIO-2017-0276
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fentanyl
Anesthetics
Propofol
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Platelet Aggregation Inhibitors
Anesthetics, Inhalation