An interventional study of rocuronium and saline in Anesthesia Intubation Complication, sponsored by Daegu Catholic University Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 2 Years to 7 Years. Per ClinicalTrials.gov, last updated 2019-10-25.
Sponsored by Daegu Catholic University Medical Center · Not applicable, Interventional, and Supportive care
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.
66 studies on the registry are indexed under Muscle Hypotonia; 14 are open to participants now.
This study's enrollment of 128 is above the median of 49 across 43 interventional studies indexed under Muscle Hypotonia.
Browse Muscle Hypotonia studies →Daegu Catholic University Medical Center is the lead sponsor of 28 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
When the patients asleep, 0.3 mg/kg rocuronium is administered.
Drug: rocuronium
When the patients asleep, 0.3 mg/kg saline is administered.
Drug: 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 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.
Also known as: Rocuronium bromide
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
Also known as: 0.9% normal saline
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.
Time frame: During 1 min after successful LMA intubation
Intubation time
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
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.
Time frame: 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.
Time frame: During 5min after successful LMA insertion
Mean blood pressure
mean blood pressure (mmHg) is recorded before and after the insertion of LMA.
Time frame: During 5-10 min after inhalation of sevoflurane
Heart rate
Heart rate is (beat per minutes) recorded before and after the insertion of LMA.
Time frame: 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 1. calm 2. crying, but can be consoled 3. Crying, cannot be consoled 4. Agitated and thrashing around
Time frame: 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
Time frame: During 60 minutes after PACU admission
Eye opening time
defined as the interval from the cessation of anesthetics to eye opening
Time frame: During 1 hour after operation
Extubation time
time from discontinuation of anesthetics to extubation
Time frame: 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
Time frame: 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
Time frame: 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%.
Time frame: 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.
Time frame: During 1 hour after operation
Plan to share: No
Ran from Apr 2018 to primary completion in Jul 2019, 15 months.
Of 17 interventional studies with no phase under Muscle Hypotonia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 28. This study's 15 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Daegu Catholic University Medical Center