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Completed

NCT Number: NCT03487003

Muscle Relaxants on Efficacy of LMA Insertion

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.

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Key information

Conditions

Anesthesia Intubation Complication Muscle Hypotonia Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

2 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Daegu Catholic University Medical Center

Daegu, 42472, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rocuronium

Drug

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.

Other names: Rocuronium bromide

Saline

Drug

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

Other names: 0.9% normal saline

Primary outcomes

  1. Oropharyngeal leak pressure (OLP)

    Time frame: During 1 min after successful LMA intubation

    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.

Secondary outcomes

  1. Intubation time

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

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

  2. Ease of intubation/mask bagging

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

    After successful LMA insertion, investigator recorded subjective difficulty during whole period of LMA manipulation by Likert scale: 1, easy 2, moderate, and 3: difficult.

  3. Fiberoptic view of LMA

    Time frame: During 5min after successful LMA insertion

    The fibreoptic view was assessed by fibreoptic bronchoscopy through the LMA and graded.

  4. Mean blood pressure

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

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

  5. Heart rate

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

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

  6. Watcha scale every 10 min from time to PACU admission to discharge

    Time frame: During 60 minutes after PACU admission

    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

  7. FLACC score on initial, 10, 20, and 30 min

    Time frame: During 60 minutes after PACU admission

    Face, legs, activity, cry, and consolability (FLACC) score is checked every 10min after PACU admission

  8. Eye opening time

    Time frame: During 1 hour after operation

    defined as the interval from the cessation of anesthetics to eye opening

  9. Extubation time

    Time frame: During 1 hour after operation

    time from discontinuation of anesthetics to extubation

  10. Peak inspiratory pressure before and after the surgery

    Time frame: During 4 hour after anesthetic inhalation

    check the peak inspiratory pressure (cmH2O) before and at the end of surgery

  11. Tidal volume ratio before and after the surgery

    Time frame: During 4 hour after anesthetic inhalation

    check the expiratory tidal volume/setting tidal volume ratio before and at the end of surgery

  12. Respiratory adverse events

    Time frame: During 1 hour after operation

    check the adverse events during emergence and PACU stay such as coughing, laryngospasm, bronchospasm, postoperative stridor and mild desaturation; SpO2 <95%.

  13. Postoperative complications

    Time frame: During 1 hour after operation

    check the adverse events including respiratory adverse events, gastric insufflation, excessive secretion, postoperative nausea and vomiting, sore throat, and tinged blood on LMA surface.

Sponsors and collaborators

Lead sponsor

Daegu Catholic University Medical Center

Other

Registry information

Official study title

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

Acronym: LMA_MR

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 3, 2018
Registry last updated
Oct 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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