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Laryngeal Mask Airway Removal During Deep Anesthesia in Children

Does Laryngeal Mask Airway Removal During Deep Anesthesia Reduce Postoperative Sore Throat in Children?

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01841866
Enrollment
456
Registered
2013-04-29
Start date
2013-05-31
Completion date
2019-10-31
Last updated
2019-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Sore Throat After LMA Removal

Keywords

post operative sore throat, laryngeal mask airway, children

Brief summary

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.

Detailed description

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.

Interventions

Sponsors

Prince of Songkla University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

* age 6-12 years * ASA physical status I-II * elective surgery

Exclusion criteria

* active airway disease * risk for aspiration * intraperitoneal or airway surgery

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Postoperative Sorethroatupto 72 hr post operative periodEvaluate post operative sorethroat by using Visual analog scale (VAS) (0-10)

Secondary

MeasureTime frameDescription
Dysphoniaupto 72 hr postoperative perioddysphonia (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
Adverse event: teeth or mucosal traumaupto 72 hr postoperative periodYes /no
laryngospasmIntraoperative and PACU periodyes/ no
Dysphagiaupto 72 hr postoperative periodDysphagia (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
DesaturationIntraoperative and PACU periodOxygen saturation less than 95%
Nausea and vomitingup to 72 hr postoperative periodusing numerical rating scale (VAS) (0-10) as a measurement tool
coughup to72 hr postoperative periodMild: \< 10 times per day Moderate 10-20 times per day Severe \> 20 times per day
BronchospasmIntraoperative and PACU periodyes/no

Countries

Thailand

Contacts

Primary ContactNgamjit Pattaravit, MD.
ngamjitp@yahoo.com66897001350
Backup ContactKamonwan Limpadapan, MD.
wildfai@gmail.com66813042738

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026