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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
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.
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.
Fentanyl 2 µg/kg for induction of anesthesia and sevoflurane 2% for maintenance
- Respiratory adverse outcomes [ Time Frame: 2 hours ]Encountered respiratory adverse outcomes such as cough
- Time to emergence [ Time Frame: 2 hours ]Emergence time defined as the time from discontinuation of the anesthetic agents until LMA removal.
- LMA insertion characteristics [ Time Frame: 2 hours ]Number of attempts and time taken to insertion, as well as adverse events encountered during insertion.
- Quality of anesthesia [ Time Frame: 2 hours ]Lack of movement, bucking, cough
- 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.
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
|Contact: Marie Aouad, MD||01350000 ext email@example.com|
|American University of Beirut||Recruiting|
|Contact: Marie Aouad, MD 9613761702 firstname.lastname@example.org|