Abstract
BackgroundThe insertion of a laryngeal mask airway (LMA) is difficult in children due to the unique features of their airways. Muscle relaxants have been reported to facilitate LMA insertion in adults; however, there is a lack of evidence supporting this in children. This trial is designed to assess the feasibility of LMA insertion with and without the use of muscle relaxants in pediatric patients under general anesthesia.Methods/designThis is a prospective, double-blind, single-center, parallel-arm, non-inferiority, randomized controlled trial to be conducted with participants aged 2–7 years who are undergoing elective ophthalmic surgery under general anesthesia. Participants are randomly assigned to one of two groups based on whether muscle relaxants are used (MR group, n = 64) or not used (Saline group, n = 64) prior to LMA insertion. The primary outcome is the oropharyngeal leak pressure (OLP) at a fixed gas flow of 3 L/min. The secondary outcomes are intubation time for successful insertion, ease of insertion and mask bagging, intubation attempt for successful insertion, successful insertion rate on the first attempt, fiberoptic view of the LMA position, postoperative complications, and changes in hemodynamic and ventilatory parameters.DiscussionWe will compare the OLPs to determine whether the muscle relaxant provides better conditions for the manipulation of the LMA. This is the first randomized controlled trial to investigate whether muscle relaxants are beneficial to the clinical performance of LMA insertion in pediatric patients under general anesthesia. This trial will be a resource for improving the process and safety of pediatric LMA insertion under general anesthesia.Trial registrationClinicalTrials.gov, NCT03487003. Registered on 18 April 2018.
Highlights
The insertion of a laryngeal mask airway (LMA) is difficult in children due to the unique features of their airways
We will compare the oropharyngeal leak pressure (OLP) to determine whether the muscle relaxant provides better conditions for the manipulation of the LMA
This is the first randomized controlled trial to investigate whether muscle relaxants are beneficial to the clinical performance of LMA insertion in pediatric patients under general anesthesia
Summary
Repeated and prolonged attempts of LMA insertion or reposition of a misplaced LMA may contribute to adverse respiratory events such as laryngospasm, hypoxemia, and pharyngeal mucosal injury. Muscle relaxants have long been used with a belief that they can positively influence upper airway anatomy and ventilation efficacy Contrary to this belief, it was reported that ventilation efficacy (represented by tidal volume and airway flow) and pharyngeal mucosal pressure were not altered after rocuronium administration [22, 23]. Various studies have measured the OLP as a primary outcome to evaluate the efficacy of LMA insertion [25,26,27]. There is a lack of studies that investigate whether muscle relaxants yield any advantages on the clinical performance of LMA insertion and placement in pediatric patients under general anesthesia.
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