Diaphragm Function After Reversal of Rocuronium-induced Neuromuscular Blockade With Sugammadex or Neostigmine in Children

Study Overview
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Brief Summary
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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.

Official Title
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Diaphragm and Lung Ultrasound After Reversal of Rocuronium-induced Neuromuscular Blockade With Sugammadex or Neostigmine in Children Undergoing Surgery : A Randomized Double-blind Controlled Trial

Conditions
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Neuromuscular Block, Residual

Intervention / Treatment
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* Drug: Sugammadex
* Drug: Neostigmine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Neostigmine<br>The use of neostigmine 0.02mg/kg for reversal of neuromuscular blocking agent. | Drug: Neostigmine<br>* 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.<br>* Other names: Neostigmine methylsulfate;|
| Experimental: Sugammadex<br>The use of sugammadex 2mg/kg for reversal of neuromuscular blocking agent. | Drug: Sugammadex<br>* 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.<br>* Other names: bridion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diaphragm excursion ratio | 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) | during diaphragm ultrasound procedure after reversal of neuromuscular blocking agent (T1), an average of 10 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified lung ultrasound score before neuromuscular blockade (LUS_T0) | 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) | during lung ultrasound procedure before neuromuscular blocking agent (T0), an average of 10 minutes | 
| modified lung ultrasound score after reversing neuromuscular blockade (LUS_T1) | 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) | during lung ultrasound procedure after reversing neuromuscular blocking agent(T1), an average of 10 minutes | 
| modified lung ultrasound score at post-anesthesia care unit (PACU) (LUS_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) | 30 minutes after entering the post-anesthesia care unit (T2) | 
| total recovery time (sec) | time from injection of a neuromuscular block reversal agent to extubation | From injection of neuromuscular block reversal agent to extubation, not to exceed 20 minutes | 
| perioperative respiratory adverse events | laryngospasm, bronchospasm, desaturation (SpO2 < 95%), airway obstruction, severe coughing, postoperative stridor during the emergence period | intraoperative | 
| length of stay in post-anesthesia care unit | 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 | 
| Adverse events occurred during post-anesthesia care unit stay | agitation, stridor, desaturation (SpO2<95%), nausea, vomiting, bradycardia, somnolence, need for oxygen support | from entering the post-anesthesia care unit to discharge from the post-anesthesia care unit, up to 24 hours | 
| postoperative pulmonary complication | pneumonia, respiratory failure, pleural effusion, atelectasis described in postoperative chest radiography, pneumothorax, bronchospasm, aspiration pneumonia | from entering the general ward after surgery to discharge from hospital, up to 7 days |