Laryngeal Mask Airway Removal During Deep Anesthesia in Children

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2013 by Prince of Songkla University
Sponsor:
Information provided by (Responsible Party):
Ngamjit Pattaravit, Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT01841866
First received: April 24, 2013
Last updated: April 26, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Post Operative Sore Throat After LMA Removal
Other: LMA removal

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Laryngeal Mask Airway Removal During Deep Anesthesia Reduce Postoperative Sore Throat in Children?

Resource links provided by NLM:


Further study details as provided by Prince of Songkla University:

Primary Outcome Measures:
  • Incidence of Postoperative Sorethroat [ Time Frame: 0-72 hr post operative period ] [ Designated as safety issue: Yes ]
    Evaluate post operative sorethroat by using Visual analog scale (VAS) (0-10)


Secondary Outcome Measures:
  • Dysphagia [ Time Frame: 0-72 hr postoperative period ] [ Designated as safety issue: Yes ]

    Dysphagia (discomfort when swallowing) 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 [ Time Frame: 0-72 hr postoperative period ] [ Designated as safety issue: Yes ]

    dysphonia (discomfort when speaking such as hoarseness) 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 trauma [ Time Frame: 0-72 hr postoperative period ] [ Designated as safety issue: Yes ]
  • laryngospasm [ Time Frame: 0-72 hr postoperative period ] [ Designated as safety issue: Yes ]
  • Bronchospasm [ Time Frame: 0-72 hr postoperative period ] [ Designated as safety issue: Yes ]
  • Desaturation [ Time Frame: 0-72 hr postoperative period ] [ Designated as safety issue: Yes ]
  • Nausea and vomiting [ Time Frame: 0-72 hr postoperative period ] [ Designated as safety issue: Yes ]
  • cough [ Time Frame: 0-72 hr postoperative period ] [ Designated as safety issue: No ]

Estimated Enrollment: 456
Study Start Date: May 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: deep
LMA removal
Other: LMA removal
Placebo Comparator: awake
LMA removal
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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01841866

Contacts
Contact: Ngamjit Pattaravit, MD. 66897001350 ngamjitp@yahoo.com
Contact: Kamonwan Limpadapan, MD. 66813042738 wildfai@gmail.com

Locations
Thailand
Prince of Songkla University Recruiting
Hatyai, Songkhla, Thailand, 90110
Contact: Ngamjit Pattaravit, MD.    66897001350    ngamjitp@yahoo.com   
Principal Investigator: Ngamjit Pattaravit, MD.         
Sub-Investigator: Kamonwan Limpadapan, MD.         
Sub-Investigator: Thavat Chanchayanon, MD.         
Sub-Investigator: Wirat Wasinwong, MD.         
Sponsors and Collaborators
Prince of Songkla University
  More Information

No publications provided

Responsible Party: Ngamjit Pattaravit, Doctor, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT01841866     History of Changes
Other Study ID Numbers: LMA246521
Study First Received: April 24, 2013
Last Updated: April 26, 2013
Health Authority: Thailand :Thai medical council

Keywords provided by Prince of Songkla University:
post operative sore throat
laryngeal mask airway
children

Additional relevant MeSH terms:
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014