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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MR group | Active Comparator | When the patients asleep, 0.3 mg/kg rocuronium is administered. |
|
| NMR group | Experimental | When the patients asleep, 0.3 mg/kg saline is administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eugene Kim, MD, PhD | Assistant professor | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daegu Catholic University Medical Center | Daegu | 42472 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26550303 | Background | 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. | |
| 20816545 | 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. |
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| ID | Term |
|---|---|
| D009123 | Muscle Hypotonia |
| ID | Term |
|---|---|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077123 | Rocuronium |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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Randomized parallel prospective non-inferiority study
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|
|
| 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 |
|
|
| 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
| During 60 minutes after PACU admission |
| 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 |
| 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 |
| 19434792 | 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. |
| 27555168 | 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. |
| 23122973 | 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. |
| 30626406 | Derived | 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. |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |