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Influence of the Neuromuscular Blockade on Mask Ventilation

Sponsor
University of Rostock (Other)
Overall Status
Completed
CT.gov ID
NCT02318810
Collaborator
(none)
300
Enrollment
1
Location
4
Arms
14
Duration (Months)
21.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Mask ventilation during induction of anesthesia can be improved by administration of neuromuscular blocking agents (NMBAs). NMBAs are usually administered after testing mask ventilation; however, muscle relaxants may improve mask ventilation and they do not alter mask ventilation. Thus, growing evidence suggests to administer muscle relaxants before testing mask ventilation. We will study different dosages of rocuronium; we assume that higher dosages of rocuronium will improve mask ventilation compared with lower dosages.

Condition or Disease Intervention/Treatment Phase
  • Drug: Rocuronium 0.3 mg/kg
  • Drug: Rocuronium 0.6 mg/kg
  • Drug: Rocuronium 0.9 mg/kg
  • Drug: Placebo
 N/A

Detailed Description

Mask ventilation during induction of anesthesia can be improved by administration of neuromuscular blocking agents (NMBAs). NMBAs are usually administered after testing mask ventilation; however, muscle relaxants may improve mask ventilation and they do not alter mask ventilation. Thus, growing evidence suggests to administer muscle relaxants before testing mask ventilation.We will administer rocuronium 0.3 mg/kg, 0.6 mg/kg, 0.9 mg/kg and saline (placebo group) before starting with mask ventilation. We will grade mask ventilation based on various scores before and after rocuronium application. Afterwards patient's tracheas will be intubated. We assess risk factors for difficult mask ventilation.

We hypothesize that rocuronium 0.9 mg/kg will be superior to rocuronium 0.3 mg/kg and saline.

Study Design

Study Type:
Interventional
Actual Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
The Influence of the Neuromuscular Blockade on Mask Ventilation; a Placebo Controlled, Randomized Trial With Three Different Dosages of Rocuronium (0.3 mg/kg, 0.6 mg/kg and 0.9 mg/kg)
Study Start Date :
Mar 1, 2015
Actual Primary Completion Date :
May 1, 2016
Actual Study Completion Date :
May 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Rocuronium 0.3 mg/kg

Patients receive rocuronium 0.3 mg/kg

Drug: Rocuronium 0.3 mg/kg
Patients receive rocuronium 0.3 mg/kg
Other Names:
  • Esmeron

    		•
    Active Comparator: Rocuronium 0.6 mg/kg

    Patients receive rocuronium 0.6 mg/kg

    Drug: Rocuronium 0.6 mg/kg
    Patients receive rocuronium 0.6 mg/kg
    Other Names:
  • Esmeron

    		•
    Active Comparator: Rocuronium 0.9 mg/kg

    Patients receive rocuronium 0.9 mg/kg

    Drug: Rocuronium 0.9 mg/kg
    Patients receive rocuronium 0.9 mg/kg
    Other Names:
  • Esmeron

    		•
    Placebo Comparator: Placebo

    Patients receive saline

    Drug: Placebo
    Patients receive saline
    Other Names:
  • Saline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of improved mask ventilation after rocuronium administration [Two minutes after rocuronium administration]

      Graded with various scores

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • patients with ASA I-III

    • required tracheal intubation

    • informed consent

    Exclusion Criteria:

    • known allergy against anesthetics

    • known difficult airway

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anesthesia and Intensive Care Medicine, University of Rostock Rostock Mecklenburg/Vorpommern Germany 18057

    Sponsors and Collaborators

    • University of Rostock

    Investigators

    • Principal Investigator: Thomas Mencke, Prof., University of Rostock

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Thomas Mencke, Prof. Dr. Thomas Mencke, University of Rostock
    ClinicalTrials.gov Identifier:
    NCT02318810
    Other Study ID Numbers:
    • A 2014 1212
    First Posted:
    Dec 17, 2014
    Last Update Posted:
    May 3, 2016
    Last Verified:
    May 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Thomas Mencke, Prof. Dr. Thomas Mencke, University of Rostock
    Muscle relaxants
    Additional relevant MeSH terms:
    Rocuronium

    Study Results

    No Results Posted as of May 3, 2016