Diaphragm Function After Reversal of Rocuronium-induced Neuromuscular Blockade With Sugammadex or Neostigmine in Children
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Neostigmine The use of neostigmine 0.02mg/kg for reversal of neuromuscular blocking agent. |
Drug: Neostigmine
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.
Other Names:
|
| Experimental: Sugammadex The use of sugammadex 2mg/kg for reversal of neuromuscular blocking agent. |
Drug: Sugammadex
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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)
- 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
- perioperative respiratory adverse events [intraoperative]
laryngospasm, bronchospasm, desaturation (SpO2 < 95%), airway obstruction, severe coughing, postoperative stridor during the emergence period
- 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
Eligibility Criteria
Criteria
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
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Patients with a history of allergy to drugs (sugammadex, rocuronium neostigmine)
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Patients with significant bradycardia
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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
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patients scheduled for lung parenchyme/diaphragm/thoracic surgery
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other researchers considered it inappropriate to participate in research.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Hospital | Seoul | Jongrogu | Korea, Republic of | 03080 |
Sponsors and Collaborators
- Seoul National University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H2212-027-1383