Muscle Relaxants on Efficacy of LMA Insertion (LMA_MR)

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia Intubation Complication
• Intervention / Treatment: Drug: rocuronium; Drug: saline

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 42472
    • Daegu Catholic University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MR group; When the patients asleep, 0.3 mg/kg rocuronium is administered.	Drug: 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.; Other Names: Rocuronium bromide
Experimental: NMR group; When the patients asleep, 0.3 mg/kg saline is administered.	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; Other Names: 0.9% normal saline

What is the study measuring?

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
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
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
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

Collaborators and Investigators

• Sponsor: Daegu Catholic University Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2018
• Primary Completion (Actual): July 30, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: March 15, 2018
• First Submitted That Met QC Criteria: March 27, 2018
• First Posted (Actual): April 3, 2018

Study Record Updates

• Last Update Posted (Actual): October 25, 2019
• Last Update Submitted That Met QC Criteria: October 24, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: laryngeal mask airway; muscle relaxant; children, preschool
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Muscle Hypotonia; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anticonvulsants; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Bromides; Rocuronium
• Other Study ID Numbers: DCMC#3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No