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Neuromuscular Block in Laryngeal Mask Airway(LMA) Insertion

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01035021
First Posted: December 18, 2009
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hyo-Seok Na, Seoul National University Bundang Hospital
  Purpose
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 Intervention
General Anesthesia Breast Disease Drug: use of rocuronium when the LMA is inserted

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hyo-Seok Na, Seoul National University Bundang Hospital:

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

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

Enrollment: 160
Study Start Date: June 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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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
  Contacts and Locations
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
  More Information

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 Submitted: December 17, 2009
First Posted: December 18, 2009
Last Update Posted: October 12, 2017
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