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Completed

NCT Number: NCT02318810

Influence of the Neuromuscular Blockade on Mask Ventilation

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.

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Key information

Conditions

Complication of Ventilation Therapy Muscle Hypotonia Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Observation of Neuromuscular Block Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesia and Intensive Care Medicine, University of Rostock

Rostock, Mecklenburg-Vorpommern, 18057, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • known allergy against anesthetics
  • known difficult airway

Treatment and study plan

Rocuronium 0.3 mg/kg

Drug

Patients receive rocuronium 0.3 mg/kg

Other names: Esmeron

Rocuronium 0.6 mg/kg

Drug

Patients receive rocuronium 0.6 mg/kg

Other names: Esmeron

Rocuronium 0.9 mg/kg

Drug

Patients receive rocuronium 0.9 mg/kg

Other names: Esmeron

Placebo

Drug

Patients receive saline

Other names: Saline

Primary outcomes

  1. Incidence of improved mask ventilation after rocuronium administration

    Time frame: Two minutes after rocuronium administration

    Graded with various scores

Sponsors and collaborators

Lead sponsor

University of Rostock

Other

Registry information

Official study 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)

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 17, 2014
Registry last updated
May 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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