Laryngeal Mask Airway Removal During Deep Anesthesia in Children
Does Laryngeal Mask Airway Removal During Deep Anesthesia Reduce Postoperative Sore Throat in Children?
1 other identifier
interventional
456
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2013
CompletedFirst Posted
Study publicly available on registry
April 29, 2013
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedJuly 31, 2019
July 1, 2019
6.4 years
April 24, 2013
July 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Postoperative Sorethroat
Evaluate post operative sorethroat by using Visual analog scale (VAS) (0-10)
upto 72 hr post operative period
Secondary Outcomes (8)
Dysphagia
upto 72 hr postoperative period
Dysphonia
upto 72 hr postoperative period
Adverse event: teeth or mucosal trauma
upto 72 hr postoperative period
laryngospasm
Intraoperative and PACU period
Bronchospasm
Intraoperative and PACU period
- +3 more secondary outcomes
Study Arms (2)
deep anesthetic state
ACTIVE COMPARATORLMA removal
awake
PLACEBO COMPARATORLMA removal
Interventions
Eligibility Criteria
You may qualify if:
- age 6-12 years
- ASA physical status I-II
- elective surgery
You may not qualify if:
- active airway disease
- risk for aspiration
- intraperitoneal or airway surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110, Thailand
Study Officials
- PRINCIPAL INVESTIGATOR
Ngamjit Pattaravit, MD
Prince of Songkla University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
April 24, 2013
First Posted
April 29, 2013
Study Start
May 1, 2013
Primary Completion
October 1, 2019
Study Completion
October 1, 2019
Last Updated
July 31, 2019
Record last verified: 2019-07