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

Not Applicable

Recruiting

• Conditions: Neuromuscular Block, Residual
• Interventions: Drug: Neostigmine; Drug: Sugammadex

• Registration Number: NCT05724550
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-15
• Study First Submitted QC: 2023-02-09
• Study First Posted: 2023-02-13
• Study Start: 2023-02-22
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-21
• Last Update Posted: 2023-04-24
• Primary Completion: 2025-02-15
• Study Completion: 2025-04-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 82

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neostigmine	Neostigmine	The use of neostigmine 0.02mg/kg for reversal of neuromuscular blocking agent.
Sugammadex	Sugammadex	The use of sugammadex 2mg/kg for reversal of neuromuscular blocking agent.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
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)
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Jongrogu, Korea, Republic of