Influence of the Neuromuscular Blockade on Mask Ventilation

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