CClinicalTrials.gg
CompletedNCT02318810Updated May 3, 2016

Influence of the Neuromuscular Blockade on Mask Ventilation

An interventional study of Rocuronium 0.3 mg/kg and Rocuronium 0.6 mg/kg in Complication of Ventilation Therapy and Observation of Neuromuscular Block, sponsored by University of Rostock. Completed at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-05-03.

Sponsored by University of Rostock · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Complication of Ventilation Therapy
  • Observation of Neuromuscular Block

Keywords

  • Muscle relaxants
03

In context

Lead sponsor

University of Rostock is the lead sponsor of 46 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • known allergy against anesthetics
  • known difficult airway
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
300 participants (actual)

Study arms

  • Active comparator
    Rocuronium 0.3 mg/kg

    Patients receive rocuronium 0.3 mg/kg

    Drug: Rocuronium 0.3 mg/kg

  • Active comparator
    Rocuronium 0.6 mg/kg

    Patients receive rocuronium 0.6 mg/kg

    Drug: Rocuronium 0.6 mg/kg

  • Active comparator
    Rocuronium 0.9 mg/kg

    Patients receive rocuronium 0.9 mg/kg

    Drug: Rocuronium 0.9 mg/kg

  • Placebo comparator
    Placebo

    Patients receive saline

    Drug: Placebo

Interventions

  • DrugRocuronium 0.3 mg/kg

    Patients receive rocuronium 0.3 mg/kg

    Also known as: Esmeron

  • DrugRocuronium 0.6 mg/kg

    Patients receive rocuronium 0.6 mg/kg

    Also known as: Esmeron

  • DrugRocuronium 0.9 mg/kg

    Patients receive rocuronium 0.9 mg/kg

    Also known as: Esmeron

  • DrugPlacebo

    Patients receive saline

    Also known as: Saline

06

What researchers measure

Primary outcomes

  1. Incidence of improved mask ventilation after rocuronium administration

    Graded with various scores

    Time frame: Two minutes after rocuronium administration

07

Study locations

1 site
  • Department of Anesthesia and Intensive Care Medicine, University of Rostock
    Rostock, Mecklenburg/Vorpommern 18057, Germany
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02318810
Lead sponsor
University of Rostock
Responsible party
Thomas Mencke (Prof. Dr. Thomas Mencke, University of Rostock) — Principal investigator
First posted
Dec 17, 2014
Start date
Mar 2015
Primary completion
May 2016
Completion
May 2016
Last update
May 3, 2016

Study contacts

Thomas Mencke, Prof.
principal investigator · University of Rostock

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion