Neuromuscular Block, Residual
Conditions
Brief summary
This study is to evaluate the recovery of diaphragm function and atelectasis after reversal of neuromuscular blockade with Neostigmine and Sugammadex using lung ultrasound and diaphragm ultrasound for children aged 2 to 7 who are scheduled for the surgical procedure under general anesthesia.
Interventions
DRUGSugammadex
* Sugammadex(100mg/mL), 2mg/kg * After confirming Train-of-four counts 4, patients allocated to sugammadex group receive sugammadex 2mg/kg for reversal of rocuronium at the end of the surgery.
DRUGNeostigmine
* Neostigmine methylsulfate(0.5mg/mL) 0.02mg/kg * After confirming Train-of-four counts 4, patients allocated to neostigmine group receive neostigmine 0.02mg/kg (maximum 5mg) combined with atropine 0.02mg/kg for reversal of rocuronium at the end of the surgery.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 7 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients between the ages of 2 and 7 who are scheduled for surgery lasting more than 1 hour under general anesthesia using a neuromuscular blocking agent
Exclusion criteria
* Patients with a history of severe respiratory disease with a high risk of bronchoconstriction * Patients with abnormal findings on preoperative chest radiography such as severe atelectasis, pneumothorax, pleural effusion, or pneumonia. * Patients with severe renal or liver disease, or neuromuscular disease * Patients with a history of allergy to drugs (sugammadex, rocuronium neostigmine) * Patients with significant bradycardia * Patients scheduled for surgery where estimated blood loss during surgery is expected to be more than 30% of estimated blood volume, or cases where fluid imbalance is expected to be severe during surgery * patients scheduled for lung parenchyme/diaphragm/thoracic surgery * other researchers considered it inappropriate to participate in research.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diaphragm excursion ratio | during diaphragm ultrasound procedure after reversal of neuromuscular blocking agent (T1), an average of 10 minute | The ratio of diaphragm excursion at the time before injecting neuromuscular blocking agent before surgery (T0) and diaphragm excursion at the time after reversal of neuromuscular blocking agent (T1) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| modified lung ultrasound score after reversing neuromuscular blockade (LUS_T1) | during lung ultrasound procedure after reversing neuromuscular blocking agent(T1), an average of 10 minutes | Both lung ultrasound score can be calculated by adding up the 12 individual pulmonary quadrant scores yielding a score between 0 (no aeration loss) and 36 (complete aeration loss) |
| modified lung ultrasound score at post-anesthesia care unit (PACU) (LUS_T2) | 30 minutes after entering the post-anesthesia care unit (T2) | Both lung ultrasound score can be calculated by adding up the 12 individual pulmonary quadrant scores yielding a score between 0 (no aeration loss) and 36 (complete aeration loss) |
| total recovery time (sec) | From injection of neuromuscular block reversal agent to extubation, not to exceed 20 minutes | time from injection of a neuromuscular block reversal agent to extubation |
| modified lung ultrasound score before neuromuscular blockade (LUS_T0) | during lung ultrasound procedure before neuromuscular blocking agent (T0), an average of 10 minutes | Both lung ultrasound score can be calculated by adding up the 12 individual pulmonary quadrant scores yielding a score between 0 (no aeration loss) and 36 (complete aeration loss) |
| length of stay in post-anesthesia care unit | from entering the post-anesthesia care unit to discharge from the post-anesthesia care unit, up to 24 hours | Length of stay in post-anesthesia care unit |
| Adverse events occurred during post-anesthesia care unit stay | from entering the post-anesthesia care unit to discharge from the post-anesthesia care unit, up to 24 hours | agitation, stridor, desaturation (SpO2\<95%), nausea, vomiting, bradycardia, somnolence, need for oxygen support |
| postoperative pulmonary complication | from entering the general ward after surgery to discharge from hospital, up to 7 days | pneumonia, respiratory failure, pleural effusion, atelectasis described in postoperative chest radiography, pneumothorax, bronchospasm, aspiration pneumonia |
| perioperative respiratory adverse events | intraoperative | laryngospasm, bronchospasm, desaturation (SpO2 \< 95%), airway obstruction, severe coughing, postoperative stridor during the emergence period |
Countries
South Korea
Outcome results
None listed