Influence of the Neuromuscular Blockade on Mask Ventilation

Observation of Neuromuscular Block Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02318810
• Other study ID #: A 2014 1212
• Status: Completed
• Phase: N/A
• First received: December 12, 2014
• Last updated: May 2, 2016
• Start date: March 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: University of Rostock
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients with ASA I-III

• required tracheal intubation

• informed consent

Exclusion Criteria:

• known allergy against anesthetics

• known difficult airway

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complication of Ventilation Therapy
• Observation of Neuromuscular Block

Intervention

Drug:
• Rocuronium 0.3 mg/kg
Patients receive rocuronium 0.3 mg/kg
• Rocuronium 0.6 mg/kg
Patients receive rocuronium 0.6 mg/kg
• Rocuronium 0.9 mg/kg
Patients receive rocuronium 0.9 mg/kg
• Placebo
Patients receive saline

Locations

Country	Name	City	State
Germany	Department of Anesthesia and Intensive Care Medicine, University of Rostock	Rostock	Mecklenburg/Vorpommern

Sponsors (1)

Lead Sponsor	Collaborator
University of Rostock

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of improved mask ventilation after rocuronium administration	Graded with various scores	Two minutes after rocuronium administration	No