Muscle Relaxants on Efficacy of LMA Insertion
- Conditions
- Anesthesia Intubation Complication
- Interventions
- Drug: saline
- Registration Number
- NCT03487003
- Lead Sponsor
- Daegu Catholic University Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 128
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NMR group saline When the patients asleep, 0.3 mg/kg saline is administered. MR group rocuronium When the patients asleep, 0.3 mg/kg rocuronium is administered.
- Primary Outcome Measures
Name Time Method Oropharyngeal leak pressure (OLP) During 1 min after successful LMA intubation 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
Name Time Method Intubation time During 5-10 min after inhalation of sevoflurane from the time of mouth opening until the time at square-wave capnography was detected
Extubation time During 1 hour after operation time from discontinuation of anesthetics to extubation
Ease of intubation/mask bagging During 5-10 min after inhalation of sevoflurane 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 During 5min after successful LMA insertion The fibreoptic view was assessed by fibreoptic bronchoscopy through the LMA and graded.
Mean blood pressure During 5-10 min after inhalation of sevoflurane mean blood pressure (mmHg) is recorded before and after the insertion of LMA.
Heart rate During 5-10 min after inhalation of sevoflurane 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 During 60 minutes after PACU admission On arrival and every 10 min after PACU admission, patients were checked Watcha scale as following 4-point scale
1. calm
2. crying, but can be consoled
3. Crying, cannot be consoled
4. Agitated and thrashing aroundFLACC score on initial, 10, 20, and 30 min During 60 minutes after PACU admission Face, legs, activity, cry, and consolability (FLACC) score is checked every 10min after PACU admission
Eye opening time During 1 hour after operation defined as the interval from the cessation of anesthetics to eye opening
Peak inspiratory pressure before and after the surgery During 4 hour after anesthetic inhalation check the peak inspiratory pressure (cmH2O) before and at the end of surgery
Tidal volume ratio before and after the surgery During 4 hour after anesthetic inhalation check the expiratory tidal volume/setting tidal volume ratio before and at the end of surgery
Respiratory adverse events During 1 hour after operation check the adverse events during emergence and PACU stay such as coughing, laryngospasm, bronchospasm, postoperative stridor and mild desaturation; SpO2 \<95%.
Postoperative complications During 1 hour after operation check the adverse events including respiratory adverse events, gastric insufflation, excessive secretion, postoperative nausea and vomiting, sore throat, and tinged blood on LMA surface.
Trial Locations
- Locations (1)
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of