Laryngeal Mask Airway Removal During Deep Anesthesia in Children

Post Operative Sore Throat After LMA Removal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01841866
• Other study ID #: LMA246521
• Status: Recruiting
• Phase: N/A
• Start date: May 2013
• Est. completion date: October 2019

Study information

• Verified date: July 2019
• Source: Prince of Songkla University
• Contact: Ngamjit Pattaravit, MD.
• Phone: 66897001350
• Email: ngamjitp[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 456
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Pharyngitis
• Post Operative Sore Throat After LMA Removal

Intervention

Other:
• LMA removal

Locations

Country	Name	City	State
Thailand	Prince of Songkla University	Hat Yai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Postoperative Sorethroat	Evaluate post operative sorethroat by using Visual analog scale (VAS) (0-10)	upto 72 hr post operative period
Secondary	Dysphagia	Dysphagia (discomfort when swallowing) by using Visual analog scale (VAS) (0-10) dysphagia score 0 = able to eat normal diet / no dysphagia; = able to swallow some solid foods; = able to swallow only semi solid foods; = able to swallow liquids only; = unable to swallow anything / total dysphagia	upto 72 hr postoperative period
Secondary	Dysphonia	dysphonia (discomfort when speaking such as hoarseness) by using numerical rating scale (VAS) (0-10) dysphonia score 0= no hoarseness; = mild/no hoarseness in the time of interview but had it previously; = moderate/only is felt by the patient or their parents; = severe/recognizable in the time of interview	upto 72 hr postoperative period
Secondary	Adverse event: teeth or mucosal trauma	Yes /no	upto 72 hr postoperative period
Secondary	laryngospasm	yes/ no	Intraoperative and PACU period
Secondary	Bronchospasm	yes/no	Intraoperative and PACU period
Secondary	Desaturation	Oxygen saturation less than 95%	Intraoperative and PACU period
Secondary	Nausea and vomiting	using numerical rating scale (VAS) (0-10) as a measurement tool	up to 72 hr postoperative period
Secondary	cough	Mild: < 10 times per day Moderate 10-20 times per day Severe > 20 times per day	up to72 hr postoperative period