Muscle Relaxants on Efficacy of LMA Insertion

NCT03487003 | Completed

• 1 other identifier: DCMC#3
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Anesthesia Intubation Complication

Keywords

laryngeal mask airway; children, preschool; muscle relaxant

Outcome Measures

Primary Outcomes (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.

  During 1 min after successful LMA intubation

Secondary Outcomes (13)

• Intubation time

  During 5-10 min after inhalation of sevoflurane

• Ease of intubation/mask bagging

  During 5-10 min after inhalation of sevoflurane

• Fiberoptic view of LMA

  During 5min after successful LMA insertion

• Mean blood pressure

  During 5-10 min after inhalation of sevoflurane

• Heart rate

  During 5-10 min after inhalation of sevoflurane

Study Arms (2)

MR group

ACTIVE COMPARATOR

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

Drug: rocuronium

NMR group

EXPERIMENTAL

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

Drug: saline

Interventions

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.

Also known as: Rocuronium bromide

MR group

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

Also known as: 0.9% normal saline

NMR group

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daegu Catholic University Medical Center: lead

Study Sites (1)

Daegu Catholic University Medical Center

Daegu, 42472, South Korea

Location

Related Publications (6)

• 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.

  PMID: 26550303 BACKGROUND

• 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.

  PMID: 20816545 BACKGROUND

• 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.

  PMID: 19434792 BACKGROUND

• 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.

  PMID: 27555168 BACKGROUND

• 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.

  PMID: 23122973 BACKGROUND

• 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.

  PMID: 30626406 DERIVED

MeSH Terms

Conditions

Muscle Hypotonia

Interventions

Rocuronium; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Eugene Kim, MD, PhD

  Assistant professor

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Randomized parallel prospective non-inferiority study

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: April 3, 2018
• Study Start: April 20, 2018
• Primary Completion: July 30, 2019
• Study Completion: July 31, 2019
• Last Updated: October 25, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)