Influence of the Neuromuscular Blockade on Mask Ventilation

Not Applicable

Completed

• Conditions: Complication of Ventilation Therapy; Observation of Neuromuscular Block
• Interventions: Drug: Placebo; Drug: Rocuronium 0.6 mg/kg; Drug: Rocuronium 0.3 mg/kg; Drug: Rocuronium 0.9 mg/kg

• Registration Number: NCT02318810
• Lead Sponsor: University of Rostock

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.

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 Timeline

• Study First Submitted: 2014-12-12
• Study First Submitted QC: 2014-12-12
• Study First Posted: 2014-12-17
• Study Start: 2015-03
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-02
• Last Update Posted: 2016-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

• known allergy against anesthetics
• known difficult airway

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients receive saline
Rocuronium 0.6 mg/kg	Rocuronium 0.6 mg/kg	Patients receive rocuronium 0.6 mg/kg
Rocuronium 0.3 mg/kg	Rocuronium 0.3 mg/kg	Patients receive rocuronium 0.3 mg/kg
Rocuronium 0.9 mg/kg	Rocuronium 0.9 mg/kg	Patients receive rocuronium 0.9 mg/kg

Primary Outcome Measures

Name	Time	Method
Incidence of improved mask ventilation after rocuronium administration	Two minutes after rocuronium administration	Graded with various scores

Trial Locations

Locations (1)

Department of Anesthesia and Intensive Care Medicine, University of Rostock; 🇩🇪 Rostock, Mecklenburg/Vorpommern, Germany