Influence of the Neuromuscular Blockade on Mask Ventilation
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)
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2014
CompletedFirst Posted
Study publicly available on registry
December 17, 2014
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedMay 3, 2016
May 1, 2016
1.2 years
December 12, 2014
May 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of improved mask ventilation after rocuronium administration
Graded with various scores
Two minutes after rocuronium administration
Study Arms (4)
Rocuronium 0.3 mg/kg
ACTIVE COMPARATORPatients receive rocuronium 0.3 mg/kg
Rocuronium 0.6 mg/kg
ACTIVE COMPARATORPatients receive rocuronium 0.6 mg/kg
Rocuronium 0.9 mg/kg
ACTIVE COMPARATORPatients receive rocuronium 0.9 mg/kg
Placebo
PLACEBO COMPARATORPatients receive saline
Interventions
Patients receive rocuronium 0.3 mg/kg
Patients receive rocuronium 0.6 mg/kg
Patients receive rocuronium 0.9 mg/kg
Eligibility Criteria
You may qualify if:
- patients with ASA I-III
- required tracheal intubation
- informed consent
You may not qualify if:
- known allergy against anesthetics
- known difficult airway
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesia and Intensive Care Medicine, University of Rostock
Rostock, Mecklenburg-Vorpommern, 18057, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Mencke, Prof.
University of Rostock
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. Thomas Mencke
Study Record Dates
First Submitted
December 12, 2014
First Posted
December 17, 2014
Study Start
March 1, 2015
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
May 3, 2016
Record last verified: 2016-05