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NCT Number: NCT05724550

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

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.

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Key information

Conditions

Neuromuscular Block, Residual Delayed Emergence from Anesthesia Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

2 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, Jongrogu, 03080, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sugammadex

Drug
  • 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: bridion

Neostigmine

Drug
  • 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: Neostigmine methylsulfate

Primary outcomes

  1. Diaphragm excursion ratio

    Time frame: 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 outcomes

  1. modified lung ultrasound score before neuromuscular blockade (LUS_T0)

    Time frame: 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)

  2. modified lung ultrasound score after reversing neuromuscular blockade (LUS_T1)

    Time frame: 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)

  3. modified lung ultrasound score at post-anesthesia care unit (PACU) (LUS_T2)

    Time frame: 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)

  4. total recovery time (sec)

    Time frame: 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

  5. perioperative respiratory adverse events

    Time frame: intraoperative

    laryngospasm, bronchospasm, desaturation (SpO2 < 95%), airway obstruction, severe coughing, postoperative stridor during the emergence period

  6. length of stay in post-anesthesia care unit

    Time frame: 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

  7. Adverse events occurred during post-anesthesia care unit stay

    Time frame: 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

  8. postoperative pulmonary complication

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 13, 2023
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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