Muscle Relaxants on Efficacy of LMA Insertion

Daegu Catholic University Medical Center128 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

128

Conditions

Anesthesia Intubation Complication

Interventions

rocuroniumDRUG

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.

salineDRUG

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

Eligibility

Sex: ALLMin age: 2 YearsMax age: 7 Years

Medical Language ↔ Plain English

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

Locations (1)

Daegu Catholic University Medical Center

Daegu, South Korea

Outcomes

Primary Outcomes

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.

Time frame: During 1 min after successful LMA intubation

Secondary Outcomes

Intubation time

from the time of mouth opening until the time at square-wave capnography was detected

Time frame: 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.

Time frame: 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.

Time frame: During 5min after successful LMA insertion

Mean blood pressure

mean blood pressure (mmHg) is recorded before and after the insertion of LMA.

Time frame: During 5-10 min after inhalation of sevoflurane

Heart rate

Heart rate is (beat per minutes) recorded before and after the insertion of LMA.

Time frame: 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 1. calm 2. crying, but can be consoled 3. Crying, cannot be consoled 4. Agitated and thrashing around

Data from ClinicalTrials.gov

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