Influence of the Neuromuscular Blockade on Mask Ventilation

May 2, 2016 updated by: Thomas Mencke, University of Rostock

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Mecklenburg/Vorpommern
      • Rostock, Mecklenburg/Vorpommern, Germany, 18057
        • Department of Anesthesia and Intensive Care Medicine, University of Rostock

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with ASA I-III
  • required tracheal intubation
  • informed consent

Exclusion Criteria:

  • known allergy against anesthetics
  • known difficult airway

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of improved mask ventilation after rocuronium administration
Time Frame: Two minutes after rocuronium administration
Graded with various scores
Two minutes after rocuronium administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rostock

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

December 12, 2014

First Submitted That Met QC Criteria

December 12, 2014

First Posted (Estimate)

December 17, 2014

Study Record Updates

Last Update Posted (Estimate)

May 3, 2016

Last Update Submitted That Met QC Criteria

May 2, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A 2014 1212

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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