Neuromuscular Block in Laryngeal Mask Airway(LMA) Insertion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hyo-Seok Na, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01035021
First received: December 17, 2009
Last updated: November 14, 2013
Last verified: November 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • success rate and insertion time [ Time Frame: when laryngeal mask airway is inserted ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • complication after the remove of LMA - bleeding, sore throat [ Time Frame: 1 hour after the LMA is removed ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 17, 2009
Last Updated: November 14, 2013
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Breast Diseases
Skin Diseases
Rocuronium
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014