An interventional study of LMA removal in Post Operative Sore Throat After LMA Removal, sponsored by Prince of Songkla University. Status unknown at 1 site in Thailand. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2019-07-31.
Sponsored by Prince of Songkla University · Not applicable, Interventional, and Treatment
Laryngeal mask airway (LMA) is widely used in children.The appropriate time to remove laryngeal mask airway is still inconclusive.Sore throat is one of common complications after general anesthesia. Sometimes postoperative sore throat affects patients' satisfaction and daily activities. It can be correlated with dysphagia and may limit oral intake especially in children.The incidence of postoperative sore throat after laryngeal mask airway insertion varies from 5.8-34% in adult(13) and 17.5% in pediatric.Somehow, almost the studies of postoperative sore throat after laryngeal mask airway removal were done in awake state. Our study object to test that post operative sore throat after LMA removal in deep anesthetized children is lower than awake children.
Patients age between 6-12 years who have ASA physical status I-II and scheduled for elective surgery will be enrolled in this study and randomly assigned into two groups (group A = awake group and group D = deep anesthetized group) by using computer-generated randomization table. The patients who have the following problems: active airway disease, risk of aspiration, intra-peritoneal or airway surgery will be excluded.
At the day of surgery, demographic data will be recorded by nurse anesthetist. Visual analog scale (VAS) will be used as a tool for evaluating preoperative sore throat.
At the operating room, after standard monitoring and pre-oxygenated with 100% oxygen via tight anesthetic face mask for 5 minutes. Propofol (3-5 mg/kg) and fentanyl(1-3 ug/kg) will be used for induction. After the patient is apnea and loss of eyelash reflex, appropriate size of classic LMA ,which is prepared by fully deflated to forms a smooth "spoon-shape" and be lubricated by water based jelly, will be applied with standard LMA insertion technique. Once LMA is in the right position, air will be inflated to the cuff of LMA, for keeping cuff pressure between 40-60 cmH2O. Air, O2 and Sevoflurane ≥ 1minimal alveolar concentration (MAC) will be used to keep the patient anesthetized. Performer of LMA insertion and number of insertion attempts will be recorded.
At the end of surgery, LMA will be removed with the technique which is followed by the group assignment, group D and group A. After that, patient will be transferred to post anesthetic care unit (PACU).
At PACU, After the patient is fully awake, the blind investigator will ask the patient to evaluate post operative sorethroat by using Visual analog scale (VAS) (0-10). Dysphagia (discomfort when swallowing) using dysphagia score (0 = able to eat normal diet / no dysphagia, 1 = able to swallow some solid foods, 2 = able to swallow only semi solid foods, 3 = able to swallow liquids only, 4 = unable to swallow anything / total dysphagia), dysphonia (discomfort when speaking such as hoarseness) using dysphonia score (0 = no hoarseness, 1 = mild/no hoarseness in the time of interview but had it previously, 2 = moderate/only is felt by the patient or their parents, 3 = severe/recognizable in the time of interview) Any adverse events will be evaluated at 1 hour in PACU. Then the evaluation will be repeated by telephoned interview at 24 and 72 hours respectively.
252 studies on the registry are indexed under Pharyngitis; 36 are open to participants now.
This study's planned enrollment of 456 is above the median of 144 across 209 interventional studies indexed under Pharyngitis.
Browse Pharyngitis studies →Prince of Songkla University is the lead sponsor of 112 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
LMA removal
Other: LMA removal
LMA removal
Other: LMA removal
Incidence of Postoperative Sorethroat
Evaluate post operative sorethroat by using Visual analog scale (VAS) (0-10)
Time frame: upto 72 hr post operative period
Dysphagia
Dysphagia (discomfort when swallowing) by using Visual analog scale (VAS) (0-10) dysphagia score 0 = able to eat normal diet / no dysphagia 1. = able to swallow some solid foods 2. = able to swallow only semi solid foods 3. = able to swallow liquids only 4. = unable to swallow anything / total dysphagia
Time frame: upto 72 hr postoperative period
Dysphonia
dysphonia (discomfort when speaking such as hoarseness) by using numerical rating scale (VAS) (0-10) dysphonia score 0= no hoarseness 1. = mild/no hoarseness in the time of interview but had it previously 2. = moderate/only is felt by the patient or their parents 3. = severe/recognizable in the time of interview
Time frame: upto 72 hr postoperative period
Adverse event: teeth or mucosal trauma
Yes /no
Time frame: upto 72 hr postoperative period
laryngospasm
yes/ no
Time frame: Intraoperative and PACU period
Bronchospasm
yes/no
Time frame: Intraoperative and PACU period
Desaturation
Oxygen saturation less than 95%
Time frame: Intraoperative and PACU period
Nausea and vomiting
using numerical rating scale (VAS) (0-10) as a measurement tool
Time frame: up to 72 hr postoperative period
cough
Mild: \< 10 times per day Moderate 10-20 times per day Severe \> 20 times per day
Time frame: up to72 hr postoperative period
This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Prince of Songkla University