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Muscle Relaxants on Efficacy of LMA Insertion (LMA_MR)

Primary Purpose

Anesthesia Intubation Complication

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
rocuronium
saline
Sponsored by
Daegu Catholic University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anesthesia Intubation Complication focused on measuring laryngeal mask airway, children, preschool, muscle relaxant

Eligibility Criteria

2 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Daegu Catholic University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

MR group

NMR group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Intubation time
from the time of mouth opening until the time at square-wave capnography was detected
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.
Fiberoptic view of LMA
The fibreoptic view was assessed by fibreoptic bronchoscopy through the LMA and graded.
Mean blood pressure
mean blood pressure (mmHg) is recorded before and after the insertion of LMA.
Heart rate
Heart rate is (beat per minutes) recorded before and after the insertion of LMA.
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
FLACC score on initial, 10, 20, and 30 min
Face, legs, activity, cry, and consolability (FLACC) score is checked every 10min after PACU admission
Eye opening time
defined as the interval from the cessation of anesthetics to eye opening
Extubation time
time from discontinuation of anesthetics to extubation
Peak inspiratory pressure before and after the surgery
check the peak inspiratory pressure (cmH2O) before and at the end of surgery
Tidal volume ratio before and after the surgery
check the expiratory tidal volume/setting tidal volume ratio before and at the end of surgery
Respiratory adverse events
check the adverse events during emergence and PACU stay such as coughing, laryngospasm, bronchospasm, postoperative stridor and mild desaturation; SpO2 <95%.
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.

Full Information

First Posted
March 15, 2018
Last Updated
October 24, 2019
Sponsor
Daegu Catholic University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03487003
Brief Title
Muscle Relaxants on Efficacy of LMA Insertion
Acronym
LMA_MR
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
April 20, 2018 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Daegu Catholic University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia Intubation Complication
Keywords
laryngeal mask airway, children, preschool, muscle relaxant

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized parallel prospective non-inferiority study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MR group
Arm Type
Active Comparator
Arm Description
When the patients asleep, 0.3 mg/kg rocuronium is administered.
Arm Title
NMR group
Arm Type
Experimental
Arm Description
When the patients asleep, 0.3 mg/kg saline is administered.
Intervention Type
Drug
Intervention Name(s)
rocuronium
Other Intervention Name(s)
Rocuronium bromide
Intervention Description
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
Intervention Name(s)
saline
Other Intervention Name(s)
0.9% normal saline
Intervention Description
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
Primary Outcome Measure Information:
Title
Oropharyngeal leak pressure (OLP)
Description
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.
Time Frame
During 1 min after successful LMA intubation
Secondary Outcome Measure Information:
Title
Intubation time
Description
from the time of mouth opening until the time at square-wave capnography was detected
Time Frame
During 5-10 min after inhalation of sevoflurane
Title
Ease of intubation/mask bagging
Description
After successful LMA insertion, investigator recorded subjective difficulty during whole period of LMA manipulation by Likert scale: 1, easy 2, moderate, and 3: difficult.
Time Frame
During 5-10 min after inhalation of sevoflurane
Title
Fiberoptic view of LMA
Description
The fibreoptic view was assessed by fibreoptic bronchoscopy through the LMA and graded.
Time Frame
During 5min after successful LMA insertion
Title
Mean blood pressure
Description
mean blood pressure (mmHg) is recorded before and after the insertion of LMA.
Time Frame
During 5-10 min after inhalation of sevoflurane
Title
Heart rate
Description
Heart rate is (beat per minutes) recorded before and after the insertion of LMA.
Time Frame
During 5-10 min after inhalation of sevoflurane
Title
Watcha scale every 10 min from time to PACU admission to discharge
Description
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
Time Frame
During 60 minutes after PACU admission
Title
FLACC score on initial, 10, 20, and 30 min
Description
Face, legs, activity, cry, and consolability (FLACC) score is checked every 10min after PACU admission
Time Frame
During 60 minutes after PACU admission
Title
Eye opening time
Description
defined as the interval from the cessation of anesthetics to eye opening
Time Frame
During 1 hour after operation
Title
Extubation time
Description
time from discontinuation of anesthetics to extubation
Time Frame
During 1 hour after operation
Title
Peak inspiratory pressure before and after the surgery
Description
check the peak inspiratory pressure (cmH2O) before and at the end of surgery
Time Frame
During 4 hour after anesthetic inhalation
Title
Tidal volume ratio before and after the surgery
Description
check the expiratory tidal volume/setting tidal volume ratio before and at the end of surgery
Time Frame
During 4 hour after anesthetic inhalation
Title
Respiratory adverse events
Description
check the adverse events during emergence and PACU stay such as coughing, laryngospasm, bronchospasm, postoperative stridor and mild desaturation; SpO2 <95%.
Time Frame
During 1 hour after operation
Title
Postoperative complications
Description
check the adverse events including respiratory adverse events, gastric insufflation, excessive secretion, postoperative nausea and vomiting, sore throat, and tinged blood on LMA surface.
Time Frame
During 1 hour after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Kim, MD, PhD
Organizational Affiliation
Assistant professor
Official's Role
Study Chair
Facility Information:
Facility Name
Daegu Catholic University Medical Center
City
Daegu
ZIP/Postal Code
42472
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26550303
Citation
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.
Results Reference
background
PubMed Identifier
20816545
Citation
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.
Results Reference
background
PubMed Identifier
19434792
Citation
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.
Results Reference
background
PubMed Identifier
27555168
Citation
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.
Results Reference
background
PubMed Identifier
23122973
Citation
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.
Results Reference
background
PubMed Identifier
30626406
Citation
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.
Results Reference
derived

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Muscle Relaxants on Efficacy of LMA Insertion

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