Muscle Relaxants on Efficacy of LMA Insertion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-20

Study Completion Date

2019-07-31

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.

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Detailed Description

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Conditions

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Anesthesia Intubation Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized parallel prospective non-inferiority study

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MR group

When the patients asleep, 0.3 mg/kg rocuronium is administered.

Group Type ACTIVE_COMPARATOR

rocuronium

Intervention Type 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.

NMR group

When the patients asleep, 0.3 mg/kg saline is administered.

Group Type EXPERIMENTAL

saline

Intervention Type 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

Interventions

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rocuronium

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.

Intervention Type DRUG

saline

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

Intervention Type DRUG

Other Intervention Names

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Rocuronium bromide 0.9% normal saline

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

Minimum Eligible Age

2 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No