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Neuromuscular Block in Laryngeal Mask Airway(LMA) Insertion

Primary Purpose

General Anesthesia, Breast Disease

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

use of rocuronium when the LMA is inserted

About this trial

This is an interventional prevention trial for General Anesthesia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

18-70 year
american society of anesthesiologist status 1-2
elective general anesthesia

Exclusion Criteria:

known or predicted difficult airway
recent sore throat
mouth opening less than 2.5 cm
at risk of aspiration

Sites / Locations

Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

group N

group R

Arm Description

Anesthesia 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.

Anesthesia 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.

Outcomes

Primary Outcome Measures

success rate and insertion time

Secondary Outcome Measures

complication after the remove of LMA - bleeding, sore throat

Full Information

NCT ID

NCT01035021

First Posted

December 17, 2009

Last Updated

November 14, 2013

Sponsor

Seoul National University Bundang Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01035021

Brief Title

Neuromuscular Block in Laryngeal Mask Airway(LMA) Insertion

Official Title

Effect of Neuromuscular Blockade on the Insertion of ProSeal™ Laryngeal Mask Airway and Postoperative Pharyngolaryngeal Discomfort

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

April 2010 (Actual)

Study Completion Date

April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Bundang Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

General Anesthesia, Breast Disease

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

160 (Actual)

8. Arms, Groups, and Interventions

Arm Title

group N

Arm Type

Active Comparator

Arm Description

Anesthesia 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.

Arm Title

group R

Arm Type

Active Comparator

Arm Description

Anesthesia 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.

Intervention Type

Drug

Intervention Name(s)

use of rocuronium when the LMA is inserted

Other Intervention Name(s)

esmeron

Intervention Description

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.

Primary Outcome Measure Information:

Title

success rate and insertion time

Time Frame

when laryngeal mask airway is inserted

Secondary Outcome Measure Information:

Title

complication after the remove of LMA - bleeding, sore throat

Time Frame

1 hour after the LMA is removed

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18-70 year american society of anesthesiologist status 1-2 elective general anesthesia Exclusion Criteria: known or predicted difficult airway recent sore throat mouth opening less than 2.5 cm at risk of aspiration

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hyoseok Na, Pf

Organizational Affiliation

Seoul National University Bundang Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Bundang Hospital

City

Seongnam-si

State/Province

Gyeonggi-do

ZIP/Postal Code

463-707

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

26252522

Citation

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.

Results Reference

derived

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Neuromuscular Block in Laryngeal Mask Airway(LMA) Insertion

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