Clinical trial NCT03487003: Muscle Relaxants on Efficacy of LMA Insertion
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
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia Intubation Complication
Keywords: laryngeal mask airway
children, preschool
muscle relaxant
Lead sponsor: Daegu Catholic University Medical Center
Sponsor class: OTHER
First posted: 2018-04-03
Enrollment: 128
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized parallel prospective non-inferiority study
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Oropharyngeal leak pressure (OLP)
timeFrame: During 1 min after successful LMA intubation
Secondary outcomes:
measure: Intubation time
timeFrame: During 5-10 min after inhalation of sevoflurane
measure: Ease of intubation/mask bagging
timeFrame: During 5-10 min after inhalation of sevoflurane
measure: Fiberoptic view of LMA
timeFrame: During 5min after successful LMA insertion
measure: Mean blood pressure
timeFrame: During 5-10 min after inhalation of sevoflurane
measure: Heart rate
timeFrame: During 5-10 min after inhalation of sevoflurane
measure: Watcha scale every 10 min from time to PACU admission to discharge
timeFrame: During 60 minutes after PACU admission
measure: FLACC score on initial, 10, 20, and 30 min
timeFrame: During 60 minutes after PACU admission
measure: Eye opening time
timeFrame: During 1 hour after operation
measure: Extubation time
timeFrame: During 1 hour after operation
measure: Peak inspiratory pressure before and after the surgery
timeFrame: During 4 hour after anesthetic inhalation
measure: Tidal volume ratio before and after the surgery
timeFrame: During 4 hour after anesthetic inhalation
measure: Respiratory adverse events
timeFrame: During 1 hour after operation
measure: Postoperative complications
timeFrame: During 1 hour after operation
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
Study officials:
affiliation: Assistant professor
name: Eugene Kim, MD, PhD
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.