Muscle Relaxants on Efficacy of LMA Insertion

Study Overview
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Brief Summary
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The use of laryngeal mask airway (LMA) is increasing in pediatric anesthesia because it provides lesser direct mechanical stimulation of the airway due to being placed above the larynx. However, LMA insertion can be more difficult in children than in adults due to their unique characteristics of pediatric airway. Neuromuscular blocking agents, so-called, muscle relaxants have long been used to facilitate insertion of airway devices. But there are pros and cons for the efficacy of muscle relaxants in LMA insertion, and most studies were investigated in adults.

Official Title
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Comparison of the Clinical Performances of Flexible Laryngeal Mask Airway in Pediatric Patients Under General Anesthesia With or Without Muscle Relaxant: a Randomized Controlled Non-inferiority Trial

Conditions
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Anesthesia Intubation Complication

Intervention / Treatment
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* Drug: rocuronium
* Drug: saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged between 2 and 7 years of American Society of Anesthesiologists physical status (ASA PS) I or II who are planned to receive ophthalmic surgery under general anesthesia Exclusion Criteria: Refusal of consent Present URI or other respiratory symptoms Oro or facial anomaly Poor dental condition who cannot open their mouth or limited mouth opening when the tracheal intubation is definitely needed

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized parallel prospective non-inferiority study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MR group<br>When the patients asleep, 0.3 mg/kg rocuronium is administered. | Drug: rocuronium<br>* After standard anesthetic monitoring (non-invasive blood pressure monitor, pulse oximetry, 3-lead echocardiography), patients are inhaled with sevoflurane. When the patients asleep, 0.3 mg/kg rocuronium is administered. After 2 min, flexible laryngeal mask airway (fLMA) is inserted using standard method. The fLMA is inflated with air to 40 cmH2O using manometry. The oropharyngeal leak pressure (OLP) was determined by the method described by Lopez-Gil and colleagues.<br>* Other names: Rocuronium bromide;|
| Experimental: NMR group<br>When the patients asleep, 0.3 mg/kg saline is administered. | Drug: saline<br>* After standard anesthetic monitoring (non-invasive blood pressure monitor, pulse oximetry, 3-lead echocardiography), patients are inhaled with sevoflurane. When the patients asleep, 0.3 mg/kg saline is administered. After 2 min, flexible laryngeal mask airway (fLMA) is inserted using standard method. The fLMA is inflated with air to 40 cmH2O using manometry. The oropharyngeal leak pressure (OLP) was determined by the method described by Lopez-Gil and colleagues<br>* Other names: 0.9% normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oropharyngeal leak pressure (OLP) | It was determined by the method describe by Lopez-Gil and colleagues. Briefly, it was measured by closing the expiratory valve of the circle system at a fixed gas flow of 3l/min, recording the airway pressure at which audible leak sound was heard. | During 1 min after successful LMA intubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation time | from the time of mouth opening until the time at square-wave capnography was detected | During 5-10 min after inhalation of sevoflurane | 
| Ease of intubation/mask bagging | After successful LMA insertion, investigator recorded subjective difficulty during whole period of LMA manipulation by Likert scale: 1, easy 2, moderate, and 3: difficult. | During 5-10 min after inhalation of sevoflurane | 
| Fiberoptic view of LMA | The fibreoptic view was assessed by fibreoptic bronchoscopy through the LMA and graded. | During 5min after successful LMA insertion | 
| Mean blood pressure | mean blood pressure (mmHg) is recorded before and after the insertion of LMA. | During 5-10 min after inhalation of sevoflurane | 
| Heart rate | Heart rate is (beat per minutes) recorded before and after the insertion of LMA. | During 5-10 min after inhalation of sevoflurane | 
| Watcha scale every 10 min from time to PACU admission to discharge | On arrival and every 10 min after PACU admission, patients were checked Watcha scale as following 4-point scale calm crying, but can be consoled Crying, cannot be consoled Agitated and thrashing around | During 60 minutes after PACU admission | 
| FLACC score on initial, 10, 20, and 30 min | Face, legs, activity, cry, and consolability (FLACC) score is checked every 10min after PACU admission | During 60 minutes after PACU admission | 
| Eye opening time | defined as the interval from the cessation of anesthetics to eye opening | During 1 hour after operation | 
| Extubation time | time from discontinuation of anesthetics to extubation | During 1 hour after operation | 
| Peak inspiratory pressure before and after the surgery | check the peak inspiratory pressure (cmH2O) before and at the end of surgery | During 4 hour after anesthetic inhalation | 
| Tidal volume ratio before and after the surgery | check the expiratory tidal volume/setting tidal volume ratio before and at the end of surgery | During 4 hour after anesthetic inhalation | 
| Respiratory adverse events | check the adverse events during emergence and PACU stay such as coughing, laryngospasm, bronchospasm, postoperative stridor and mild desaturation; SpO2 <95%. | During 1 hour after operation | 
| Postoperative complications | check the adverse events including respiratory adverse events, gastric insufflation, excessive secretion, postoperative nausea and vomiting, sore throat, and tinged blood on LMA surface. | During 1 hour after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laryngeal mask airway, children, preschool, muscle relaxant