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Neuromuscular Block in Laryngeal Mask Airway(LMA) Insertion

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ClinicalTrials.gov Identifier: NCT01035021
Recruitment Status : Completed
First Posted : December 18, 2009
Last Update Posted : November 15, 2013
Sponsor:
Information provided by (Responsible Party):
Hyo-Seok Na, Seoul National University Bundang Hospital

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).

Condition or disease Intervention/treatment Phase
General Anesthesia Breast Disease Drug: use of rocuronium when the LMA is inserted Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Neuromuscular Blockade on the Insertion of ProSeal™ Laryngeal Mask Airway and Postoperative Pharyngolaryngeal Discomfort
Study Start Date : June 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: group N
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.
Drug: use of rocuronium when the LMA is inserted
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.
Other Name: esmeron
Active Comparator: group R
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.
Drug: use of rocuronium when the LMA is inserted
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.
Other Name: esmeron



Primary Outcome Measures :
  1. success rate and insertion time [ Time Frame: when laryngeal mask airway is inserted ]

Secondary Outcome Measures :
  1. complication after the remove of LMA - bleeding, sore throat [ Time Frame: 1 hour after the LMA is removed ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01035021


Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Principal Investigator: Hyoseok Na, Pf Seoul National University Bundang Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hyo-Seok Na, Dr., Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01035021     History of Changes
Other Study ID Numbers: LMA_M_relax
First Posted: December 18, 2009    Key Record Dates
Last Update Posted: November 15, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Breast Diseases
Skin Diseases
Propofol
Remifentanil
Rocuronium
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents