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Anesthesia Intubation ComplicationLMA_MRNCT03487003

Muscle Relaxants on Efficacy of LMA Insertion

A study testing rocuronium and saline in people with Anesthesia Intubation Complication, run by Daegu Catholic University Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 2 to 7 years
Conditions the study is for
Anesthesia Intubation Complication
What is being tested?
rocuronium and saline
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
1 siteSouth Korea
Study dates
20 Apr 2018to 31 Jul 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 7 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Daegu Catholic University Medical Center

    Daegu, 42472

Other trials in South Korea

About this study

Official 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

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.

Being tested
rocuronium, saline
Keywords
laryngeal mask airway, children, preschool, muscle relaxant
Medical subject headings
Muscle Hypotonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rocuroniumDrug

    Also called Rocuronium bromide

    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

    Also called 0.9% normal 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

Study groups in NCT03487003
Study groupRoleWhat they receive
MR groupActive comparatorWhen the patients asleep, 0.3 mg/kg rocuronium is administered.
Receives: Drug: rocuronium
NMR groupExperimentalWhen the patients asleep, 0.3 mg/kg saline is administered.
Receives: Drug: saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: During 1 min after successful LMA intubation

Secondary outcomes (13)

  1. Intubation time

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

    Measured: During 5-10 min after inhalation of sevoflurane

  2. 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.

    Measured: During 5-10 min after inhalation of sevoflurane

  3. Fiberoptic view of LMA

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

    Measured: During 5min after successful LMA insertion

  4. Mean blood pressure

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

    Measured: During 5-10 min after inhalation of sevoflurane

  5. Heart rate

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

    Measured: During 5-10 min after inhalation of sevoflurane

  6. 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

    Measured: During 60 minutes after PACU admission

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

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

    Measured: During 60 minutes after PACU admission

  8. Eye opening time

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

    Measured: During 1 hour after operation

  9. Extubation time

    time from discontinuation of anesthetics to extubation

    Measured: During 1 hour after operation

  10. Peak inspiratory pressure before and after the surgery

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

    Measured: During 4 hour after anesthetic inhalation

  11. Tidal volume ratio before and after the surgery

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

    Measured: During 4 hour after anesthetic inhalation

  12. Respiratory adverse events

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

    Measured: During 1 hour after operation

  13. 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.

    Measured: During 1 hour after operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2018
  2. Study start20 Apr 2018
  3. Primary completion30 Jul 2019
  4. Study completion31 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized parallel prospective non-inferiority study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03487003
Sponsor's protocol ID
DCMC#3
Acronym
LMA_MR
Status last verified
Oct 2019
First submitted
15 Mar 2018
Last updated
25 Oct 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gong YH, Yi J, Zhang Q, Xu L. Effect of low dose rocuronium in preventing ventilation leak for flexible laryngeal mask airway during radical mastectomy. Int J Clin Exp Med. 2015 Aug 15;8(8):13616-21. eCollection 2015.

    PubMed 26550303

  • von Ungern-Sternberg BS, Boda K, Chambers NA, Rebmann C, Johnson C, Sly PD, Habre W. Risk assessment for respiratory complications in paediatric anaesthesia: a prospective cohort study. Lancet. 2010 Sep 4;376(9743):773-83. doi: 10.1016/S0140-6736(10)61193-2.

    PubMed 20816545

  • Ghai B, Wig J. Comparison of different techniques of laryngeal mask placement in children. Curr Opin Anaesthesiol. 2009 Jun;22(3):400-4. doi: 10.1097/aco.0b013e3283294d06.

    PubMed 19434792

  • Hattori K, Komasawa N, Miyazaki Y, Kido H, Deguchi S, Minami T. Muscle relaxant facilitates i-gel insertion by novice doctors: A prospective randomized controlled trial. J Clin Anesth. 2016 Sep;33:218-22. doi: 10.1016/j.jclinane.2016.03.058. Epub 2016 May 4.

    PubMed 27555168

  • Chen BZ, Tan L, Zhang L, Shang YC. Is muscle relaxant necessary in patients undergoing laparoscopic gynecological surgery with a ProSeal LMA? J Clin Anesth. 2013 Feb;25(1):32-5. doi: 10.1016/j.jclinane.2012.06.004. Epub 2012 Nov 2.

    PubMed 23122973

  • Byun SH, Kim SJ, Kim E. Comparison of the clinical performance of the flexible laryngeal mask airway in pediatric patients under general anesthesia with or without a muscle relaxant: study protocol for a randomized controlled trial. Trials. 2019 Jan 9;20(1):31. doi: 10.1186/s13063-018-3141-2.

    PubMed 30626406

Questions about this trial

What is this clinical trial studying?

A study testing rocuronium and saline in people with Anesthesia Intubation Complication, run by Daegu Catholic University Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oropharyngeal leak pressure (OLP) (time frame: During 1 min after successful LMA intubation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03487003, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2019.

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