Laryngeal Mask Airway Removal During Deep Anesthesia in Children

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

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.

Study Overview

• Status: Unknown
• Conditions: Post Operative Sore Throat After LMA Removal
• Intervention / Treatment: Other: LMA removal

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.

• Study Type: Interventional
• Enrollment (Anticipated): 456
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Songkhla
    • Hat Yai, Songkhla, Thailand, 90110
      • Recruiting
      • Prince of Songkla University
      • Contact: Ngamjit Pattaravit, MD.; Phone Number: 66897001350; Email: ngamjitp@yahoo.com
      • Principal Investigator: Ngamjit Pattaravit, MD.
      • Sub-Investigator: Kamonwan Limpadapan, MD.
      • Sub-Investigator: Thavat Chanchayanon, MD.
      • Sub-Investigator: Wirat Wasinwong, MD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: deep anesthetic state; LMA removal	Other: LMA removal
Placebo Comparator: awake; LMA removal	Other: LMA removal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Postoperative Sorethroat	Evaluate post operative sorethroat by using Visual analog scale (VAS) (0-10)	upto 72 hr post operative period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Adverse event: teeth or mucosal trauma	Yes /no	upto 72 hr postoperative period
laryngospasm	yes/ no	Intraoperative and PACU period
Bronchospasm	yes/no	Intraoperative and PACU period
Desaturation	Oxygen saturation less than 95%	Intraoperative and PACU period
Nausea and vomiting	using numerical rating scale (VAS) (0-10) as a measurement tool	up to 72 hr postoperative period
cough	Mild: < 10 times per day Moderate 10-20 times per day Severe > 20 times per day	up to72 hr postoperative period

Collaborators and Investigators

• Sponsor: Prince of Songkla University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: April 24, 2013
• First Submitted That Met QC Criteria: April 26, 2013
• First Posted (Estimate): April 29, 2013

Study Record Updates

• Last Update Posted (Actual): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 30, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: children; laryngeal mask airway; post operative sore throat
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis
• Other Study ID Numbers: LMA246521