Muscle Relaxants on Efficacy of LMA Insertion

Anesthesia Intubation Complication Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03487003
• Other study ID #: DCMC#3
• Status: Completed
• Phase: N/A
• Start date: April 20, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: October 2019
• Source: Daegu Catholic University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: July 31, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia Intubation Complication
• Muscle Hypotonia

Intervention

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.
• 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

Locations

Country	Name	City	State
Korea, Republic of	Daegu Catholic University Medical Center	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Daegu Catholic University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

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. — View Citation

Ghai B, Wig J. Comparison of different techniques of laryngeal mask placement in children. Curr Opin Anaesthesiol. 2009 Jun;22(3):400-4. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Fiberoptic view of LMA	The fibreoptic view was assessed by fibreoptic bronchoscopy through the LMA and graded.	During 5min after successful LMA insertion
Secondary	Mean blood pressure	mean blood pressure (mmHg) is recorded before and after the insertion of LMA.	During 5-10 min after inhalation of sevoflurane
Secondary	Heart rate	Heart rate is (beat per minutes) recorded before and after the insertion of LMA.	During 5-10 min after inhalation of sevoflurane
Secondary	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
Secondary	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
Secondary	Eye opening time	defined as the interval from the cessation of anesthetics to eye opening	During 1 hour after operation
Secondary	Extubation time	time from discontinuation of anesthetics to extubation	During 1 hour after operation
Secondary	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
Secondary	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
Secondary	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
Secondary	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