The goal of this clinical trial is to compare the airway management effects of flexible reinforced laryngeal mask and endotracheal tube in childhood adenotonsillectomy. Participants will be randomly allocated to two groups: endotracheal tube group (ETT) and flexible reinforced laryngeal mask group (FLMA). For those in ETT group: they will be intubated after induction of anesthesia .For those in FLMA group: they will be put in flexible reinforced laryngeal mask after induction of anesthesia . The investigators will compare FLMA with ETT to see if flexible reinforced laryngeal mask can be used safely and effectively in childhood adenotonsillectomy，and if there will be less severe adverse events in FLMA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
100
In the FLMA group, a FLMA was applied according to the manufacturer's recommendations. After lubrication of the posterior surface with oxybuprocaine hydrochloride gel, the FLMA was inserted after propping the shoulders. Its cuff was fully deflated before insertion, and the pressure was adjusted to 40 cm H2O with a manometer after insertion.
In the ETT group, guided by a visual laryngoscope, a ETT was intubated after lubrication of the surface with oxybuprocaine hydrochloride gel: endotracheal tube size = (16+ age) /4. The cuff pressure of ETT was adjusted to 20 cm H2O with a handheld manometer after inflation.
Maternal and Child Health Hospital of Hubei Province
Wuhan, Hubei, China
Peak airway pressure
Maximum peak airway pressure during surgery
Time frame: intraoperative period,10 minutes-1 hours
Petco2
Petco2 at the end of surgery
Time frame: intraoperative period,10 minutes-1 hour
Ventilation leakage or not
Using volume ventilation, tidal volume set to 10 ml /kg, Ventilation leakage is defined as reaching more than 20% of the set tidal volume.
Time frame: intraoperative period,10 minutes-1 hour
Mean arterial pressure (MAP)
MAP level will be monitored and recorded at 6 time points, including the entry into the operation room (Time 0), 2 min after anesthesia induction (Time 1), implantation of FLMA or ETT (Time 2), implantation of mouth opener (Time 3) ，at the end of surgery (Time 4), and after removal of FLMA or ETT (Time 5)
Time frame: Intraoperative period, 30 minutes - 1.5 hours
Heart rate (HR)
HR will be monitored and recorded at 4 time points, including the entry into the operation room (Time 0), 2 min after anesthesia induction (Time 1), implantation of FLMA or ETT (Time 2), implantation of mouth opener (Time 3) ，at the end of surgery (Time 4), and after removal of FLMA or ETT (Time 5)
Time frame: Intraoperative period, 30 min - 1.5 hours
Recovery time
Time to fully awake, defined as by a modified Aldrete score which will be recorded every 3 minutes from the end of the procedure with a recovery index (MAS) of 9 or more.
Time frame: Postoperative 30 minutes
Extubation time
Time to extubate, defined as occurrence of regular respiration from the end of the procedure.
Time frame: Postoperative 30 minutes
Dosage of anesthetic
The total amount of sedative and analgesic drugs will be recorded.
Time frame: Intraoperative period, 30 minutes - 1.5 hours
Success of FLMA or ETT
The first success of FLMA or ETT rate will be recorded, and insertion over three times will be considered as failed intubation.
Time frame: Intraoperative period, 10 minutes - 1hour
Surgeon satisfaction
Record the satisfaction of the surgeon with the FLMA or ETT, defined as a score out of100.
Time frame: Postoperative 30 minutes
Adverse events
The adverse events will be monitored and recorded during the operation and post-operation. AE will include: nausea and vomiting, reflux aspiration, hoarseness, dysphagia, sore throat, coughing, bronchospasm, laryngeal spasm, mask with blood, respiratory depression (defined as SpO2\< 90%),
Time frame: Postoperative 1 hour
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