Neuromuscular Block in Laryngeal Mask Airway(LMA) Insertion
Effect of Neuromuscular Blockade on the Insertion of ProSeal™ Laryngeal Mask Airway and Postoperative Pharyngolaryngeal Discomfort
1 other identifier
interventional
160
1 country
1
Brief Summary
The aim of this study is to evaluate the success rate, insertion time and complication depending on the use of neuromuscular blocking agent when inserting the laryngeal mask airway (LMA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2009
Shorter than P25 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
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 17, 2009
CompletedFirst Posted
Study publicly available on registry
December 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedNovember 15, 2013
November 1, 2013
10 months
December 17, 2009
November 14, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
success rate and insertion time
when laryngeal mask airway is inserted
Secondary Outcomes (1)
complication after the remove of LMA - bleeding, sore throat
1 hour after the LMA is removed
Study Arms (2)
group N
ACTIVE COMPARATORAnesthesia is induced with propofol and remifentanil and LMA is inserted by the standard technique according to eht manufacturer's instruction. Rocuronium is administered for the operation.
group R
ACTIVE COMPARATORAnesthesia is induced with a propofol and remifentanil and rocuronium 0.06 mg/kg is injected. Insertion of LMA is performed by the standard technique according to the manufacturer's instruction.
Interventions
Anesthesia is induced with a propofol and remifentanil in both groups, however rocuronium 0.06 mg/kg is injected only in group R. Insertion of LMA is performed by the standard technique according to the manufacturer's instruction. In group N, rocuronium is administered for the operation.
Eligibility Criteria
You may qualify if:
- year
- american society of anesthesiologist status 1-2
- elective general anesthesia
You may not qualify if:
- known or predicted difficult airway
- recent sore throat
- mouth opening less than 2.5 cm
- at risk of aspiration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707, South Korea
Related Publications (1)
Na HS, Jeon YT, Shin HJ, Oh AY, Park HP, Hwang JW. Effect of Paralysis at the Time of ProSeal Laryngeal Mask Airway Insertion on Pharyngolaryngeal Morbidities. A Randomized Trial. PLoS One. 2015 Aug 7;10(8):e0134130. doi: 10.1371/journal.pone.0134130. eCollection 2015.
PMID: 26252522DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyoseok Na, Pf
Seoul National University Bundang Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
December 17, 2009
First Posted
December 18, 2009
Study Start
June 1, 2009
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
November 15, 2013
Record last verified: 2013-11