Optimal Inspiratory Pressure for Facemask Pressure-controlled Ventilation in Children
Condition: Child; Anesthesia
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      The purpose of this study is to find an optimal inspiratory pressure to provide adequate
      tidal volume and prevent gastric insufflation in pediatric patients.

      The children under 5 years old are randomly assigned to muscle relaxation group and
      non-relaxation group. For muscle relaxation group, routine anesthesia induction is performed
      with muscle relaxant and mask ventilation is started by pressure-controlled mechanical
      ventilation. Gastric auscultation and abdominal ultrasonography are performed simultaneously
      during mask ventilation to detect inflow of air. Initial inspiratory airway pressure is 10
      cmH2O and increased gradually by 2 cmH2O until gastric insufflation is detected by either of
      two methods. Tracheal intubation is done after detection of gas.

      For non-relaxation group, mask ventilation is performed in a same manner, without muscle
      relaxant. After detection of gas by any of the two methods, rocuronium 0.6 mg/kg is
      administered and tracheal intubation is performed.
    

Detailed description: 
      The purpose of this study is to find an optimal inspiratory pressure to provide adequate
      tidal volume and prevent gastric insufflation in pediatric patients.

      The children under 5 years old are randomly assigned to muscle relaxation group and
      non-relaxation group. Stratum was constructed based on age and randomization scheme was
      performed separately within each stratum. Block randomization was done to ensure balance of
      the age groups.

      For muscle relaxation group, routine anesthesia induction is performed with muscle relaxant
      and mask ventilation is started by pressure-controlled mechanical ventilation. Gastric
      auscultation and abdominal ultrasonography are performed simultaneously during mask
      ventilation to detect inflow of air. Initial inspiratory airway pressure is 10 cmH2O and
      increased gradually by 2 cmH2O until gastric insufflation is detected by either of two
      methods. Tracheal intubation is done after detection of gas.

      For non-relaxation group, mask ventilation is performed in a same manner, without muscle
      relaxant. After detection of gas by any of the two methods, rocuronium 0.6 mg/kg is
      administered and tracheal intubation is performed.

      Tidal volume and oxygen saturation are recorded during study period.
    

Intervention name(s): Mask ventilation; Rocuronium
Intervention type(s): Other; Drug
Intervention description(s): Mask ventilation is performed after administration of rocuronium or not. Initial inspiratory pressure is set as 10 cmH2O and increased gradually by 2 cmH2O until gastric insufflation is detected by either of two methods. Tracheal intubation is done after detection of gas.; Rocuronium 0.6 mg/kg is injected before mask ventilation in muscle relaxant group or after finish of study in non-relaxant group.
Intervention MeSH terms: Rocuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic