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Laryngeal Mask Airway Removal During Deep Anesthesia in Children

Primary Purpose

Post Operative Sore Throat After LMA Removal

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
LMA removal
Sponsored by
Prince of Songkla University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Sore Throat After LMA Removal focused on measuring post operative sore throat, laryngeal mask airway, children

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Prince of Songkla UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

deep anesthetic state

awake

Arm Description

LMA removal

LMA removal

Outcomes

Primary Outcome Measures

Incidence of Postoperative Sorethroat
Evaluate post operative sorethroat by using Visual analog scale (VAS) (0-10)

Secondary Outcome Measures

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
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
Adverse event: teeth or mucosal trauma
Yes /no
laryngospasm
yes/ no
Bronchospasm
yes/no
Desaturation
Oxygen saturation less than 95%
Nausea and vomiting
using numerical rating scale (VAS) (0-10) as a measurement tool
cough
Mild: < 10 times per day Moderate 10-20 times per day Severe > 20 times per day

Full Information

First Posted
April 24, 2013
Last Updated
July 30, 2019
Sponsor
Prince of Songkla University
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1. Study Identification

Unique Protocol Identification Number
NCT01841866
Brief Title
Laryngeal Mask Airway Removal During Deep Anesthesia in Children
Official Title
Does Laryngeal Mask Airway Removal During Deep Anesthesia Reduce Postoperative Sore Throat in Children?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (Actual)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince of Songkla University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Sore Throat After LMA Removal
Keywords
post operative sore throat, laryngeal mask airway, children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
456 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
deep anesthetic state
Arm Type
Active Comparator
Arm Description
LMA removal
Arm Title
awake
Arm Type
Placebo Comparator
Arm Description
LMA removal
Intervention Type
Other
Intervention Name(s)
LMA removal
Primary Outcome Measure Information:
Title
Incidence of Postoperative Sorethroat
Description
Evaluate post operative sorethroat by using Visual analog scale (VAS) (0-10)
Time Frame
upto 72 hr post operative period
Secondary Outcome Measure Information:
Title
Dysphagia
Description
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
Time Frame
upto 72 hr postoperative period
Title
Dysphonia
Description
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
Time Frame
upto 72 hr postoperative period
Title
Adverse event: teeth or mucosal trauma
Description
Yes /no
Time Frame
upto 72 hr postoperative period
Title
laryngospasm
Description
yes/ no
Time Frame
Intraoperative and PACU period
Title
Bronchospasm
Description
yes/no
Time Frame
Intraoperative and PACU period
Title
Desaturation
Description
Oxygen saturation less than 95%
Time Frame
Intraoperative and PACU period
Title
Nausea and vomiting
Description
using numerical rating scale (VAS) (0-10) as a measurement tool
Time Frame
up to 72 hr postoperative period
Title
cough
Description
Mild: < 10 times per day Moderate 10-20 times per day Severe > 20 times per day
Time Frame
up to72 hr postoperative period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ngamjit Pattaravit, MD.
Phone
66897001350
Email
ngamjitp@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kamonwan Limpadapan, MD.
Phone
66813042738
Email
wildfai@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ngamjit Pattaravit, MD
Organizational Affiliation
Prince of Songkla University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Songkla University
City
Hat Yai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ngamjit Pattaravit, MD.
Phone
66897001350
Email
ngamjitp@yahoo.com
First Name & Middle Initial & Last Name & Degree
Ngamjit Pattaravit, MD.
First Name & Middle Initial & Last Name & Degree
Kamonwan Limpadapan, MD.
First Name & Middle Initial & Last Name & Degree
Thavat Chanchayanon, MD.
First Name & Middle Initial & Last Name & Degree
Wirat Wasinwong, MD.

12. IPD Sharing Statement

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Laryngeal Mask Airway Removal During Deep Anesthesia in Children

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