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Influence of the Neuromuscular Blockade on Mask Ventilation

U

University of Rostock

Status

Completed

Conditions

Observation of Neuromuscular Block
Complication of Ventilation Therapy

Treatments

Drug: Rocuronium 0.3 mg/kg
Drug: Rocuronium 0.6 mg/kg
Drug: Placebo
Drug: Rocuronium 0.9 mg/kg

Study type

Interventional

Funder types

Other

Identifiers

NCT02318810
A 2014 1212

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • known allergy against anesthetics
  • known difficult airway

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

300 participants in 4 patient groups, including a placebo group

Rocuronium 0.3 mg/kg
Active Comparator group
Description:
Patients receive rocuronium 0.3 mg/kg
Treatment:
Drug: Rocuronium 0.3 mg/kg
Rocuronium 0.6 mg/kg
Active Comparator group
Description:
Patients receive rocuronium 0.6 mg/kg
Treatment:
Drug: Rocuronium 0.6 mg/kg
Rocuronium 0.9 mg/kg
Active Comparator group
Description:
Patients receive rocuronium 0.9 mg/kg
Treatment:
Drug: Rocuronium 0.9 mg/kg
Placebo
Placebo Comparator group
Description:
Patients receive saline
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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