Influence of the Neuromuscular Blockade on Mask Ventilation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Complication of Ventilation Therapy, Observation of Neuromuscular Block

Intervention / Treatment
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* Drug: Rocuronium 0.3 mg/kg
* Drug: Rocuronium 0.6 mg/kg
* Drug: Rocuronium 0.9 mg/kg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with ASA I-III required tracheal intubation informed consent Exclusion Criteria: known allergy against anesthetics known difficult airway

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rocuronium 0.3 mg/kg<br>Patients receive rocuronium 0.3 mg/kg | Drug: Rocuronium 0.3 mg/kg<br>* Patients receive rocuronium 0.3 mg/kg<br>* Other names: Esmeron;|
| Active Comparator: Rocuronium 0.6 mg/kg<br>Patients receive rocuronium 0.6 mg/kg | Drug: Rocuronium 0.6 mg/kg<br>* Patients receive rocuronium 0.6 mg/kg<br>* Other names: Esmeron;|
| Active Comparator: Rocuronium 0.9 mg/kg<br>Patients receive rocuronium 0.9 mg/kg | Drug: Rocuronium 0.9 mg/kg<br>* Patients receive rocuronium 0.9 mg/kg<br>* Other names: Esmeron;|
| Placebo Comparator: Placebo<br>Patients receive saline | Drug: Placebo<br>* Patients receive saline<br>* Other names: Saline;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Muscle relaxants