Child, Anesthesia
Conditions
Brief 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.
Interventions
OTHERMask ventilation
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.
DRUGRocuronium
Rocuronium 0.6 mg/kg is injected before mask ventilation in muscle relaxant group or after finish of study in non-relaxant group.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Months to 5 Years
Healthy volunteers
Yes
Inclusion criteria
* Pediatric patients scheduled for elective surgery under general anesthesia * BMI \< 30 * ASA class 1 or 2
Exclusion criteria
* with difficult airway * preexisting pulmonary disease * upper respiratory tract infection * intestinal obstruction * with risk of pulmonary aspiration * history of stoke or moyamoya disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inspiratory Pressure That Cause Gastric Insufflation | Interval between start of mask ventilation and detection of gastric insufflation, an expected average of 100 sec | Difference in the inspiratory pressure that minimized the incidence of gastric insufflation, yet guaranteed a tidal volume of at least 6 ml/kg between the neuromuscular blocker and non-neuromuscular blocker groups. Gastric insufflation was measured using both gastric ultrasonography and epigastric auscultation. |
Secondary
| Measure | Time frame |
|---|---|
| Diagnostic Method That Detects Gastric Insufflation First | Interval between start of mask ventilation and detection of gastric insufflation, an expected average of 100 sec |
Countries
South Korea
Participant flow
Recruitment details
This single-center study was performed in a tertiary children's hospital in Republic of Korea.
Participants by arm
| Arm | Count |
|---|---|
| Neuromuscular Blocker Group Facemask ventilation was performed after rocuronium (0.6mg/kg) was administered. | 60 |
| Non-neuromuscular Blocker Group Facemask ventilation was performed without rocuronium administration. | 52 |
| Total | 112 |
Baseline characteristics
| Characteristic | Total | Neuromuscular Blocker Group | Non-neuromuscular Blocker Group |
|---|---|---|---|
| Age, Continuous | 1.3 years | 1.2 years | 1.4 years |
| Height | 77.2 cm STANDARD_DEVIATION 14.5 | 76.0 cm STANDARD_DEVIATION 14.3 | 78.8 cm STANDARD_DEVIATION 14.2 |
| Sex: Female, Male Female | 42 Participants | 21 Participants | 21 Participants |
| Sex: Female, Male Male | 70 Participants | 39 Participants | 31 Participants |
| Weight | 10.3 kg STANDARD_DEVIATION 3.7 | 10.0 kg STANDARD_DEVIATION 3.8 | 10.4 kg STANDARD_DEVIATION 3.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 52 |
| other Total, other adverse events | 0 / 60 | 0 / 52 |
| serious Total, serious adverse events | 0 / 60 | 0 / 52 |
Outcome results
Primary
Inspiratory Pressure That Cause Gastric Insufflation
Difference in the inspiratory pressure that minimized the incidence of gastric insufflation, yet guaranteed a tidal volume of at least 6 ml/kg between the neuromuscular blocker and non-neuromuscular blocker groups. Gastric insufflation was measured using both gastric ultrasonography and epigastric auscultation.
Time frame: Interval between start of mask ventilation and detection of gastric insufflation, an expected average of 100 sec
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Neuromuscular Blocker Group | Inspiratory Pressure That Cause Gastric Insufflation | 13 cmH2O |
| Non-neuromuscular Blocker Group | Inspiratory Pressure That Cause Gastric Insufflation | 13 cmH2O |
Secondary
Diagnostic Method That Detects Gastric Insufflation First
Time frame: Interval between start of mask ventilation and detection of gastric insufflation, an expected average of 100 sec
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Neuromuscular Blocker Group | Diagnostic Method That Detects Gastric Insufflation First | Auscultation | 4 Participants |
| Neuromuscular Blocker Group | Diagnostic Method That Detects Gastric Insufflation First | Simultaneous detection by both methods | 12 Participants |
| Neuromuscular Blocker Group | Diagnostic Method That Detects Gastric Insufflation First | Ultrasound | 44 Participants |
| Non-neuromuscular Blocker Group | Diagnostic Method That Detects Gastric Insufflation First | Auscultation | 10 Participants |
| Non-neuromuscular Blocker Group | Diagnostic Method That Detects Gastric Insufflation First | Simultaneous detection by both methods | 19 Participants |
| Non-neuromuscular Blocker Group | Diagnostic Method That Detects Gastric Insufflation First | Ultrasound | 23 Participants |