Neuromuscular Block, ResidualNCT05724550
Diaphragm Function After Reversal of Rocuronium-induced Neuromuscular Blockade With Sugammadex or Neostigmine in Children
A study testing Sugammadex and Neostigmine in people with Neuromuscular Block, Residual, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Block, Residual
- What is being tested?
- Sugammadex and Neostigmine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Feb 2023to 8 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Jongrogu, 03080
About this study
Official 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
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.
- Conditions
- Neuromuscular Block, Residual
- Being tested
- Sugammadex, Neostigmine
- Medical subject headings
- Delayed Emergence from Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
Also called bridion
- 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.
NeostigmineDrug
Also called Neostigmine methylsulfate
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Neostigmine | Active comparator | The use of neostigmine 0.02mg/kg for reversal of neuromuscular blocking agent. Receives: Drug: Neostigmine |
| Sugammadex | Experimental | The use of sugammadex 2mg/kg for reversal of neuromuscular blocking agent. Receives: Drug: Sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: during diaphragm ultrasound procedure after reversal of neuromuscular blocking agent (T1), an average of 10 minute
Secondary outcomes (8)
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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: intraoperative
length of stay in post-anesthesia care unit
Length of stay in post-anesthesia care unit
Measured: 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
Measured: 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
Measured: from entering the general ward after surgery to discharge from hospital, up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start22 Feb 2023
- Primary completion7 Jun 2024
- Study completion8 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular Block, ResidualStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji-Hyun Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724550
- Sponsor's protocol ID
- H2212-027-1383
- Status last verified
- Apr 2025
- First submitted
- 15 Jan 2023
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Park JB, Kim TW, Ji SH, Jang YE, Kim EH, Kim JT, Kim HS, Lee JH. Ultrasonographic assessment of sugammadex-enhanced early recovery of diaphragmatic function in children: A randomised double-blind controlled trial. Eur J Anaesthesiol. 2025 Oct 1;42(10):907-915. doi: 10.1097/EJA.0000000000002231. Epub 2025 Jul 7.
PubMed 40625141
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05724550
- Acronym / sponsor ID
- H2212-027-1383
- Conditions
- Neuromuscular Block, Residual
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 7 Jun 2024 (actual)
- Study completion
- 8 Jun 2024 (actual)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neostigmine | Active comparator | Drug: NeostigmineThe use of neostigmine 0.02mg/kg for reversal of neuromuscular blocking agent. |
| Sugammadex | Experimental | Drug: SugammadexThe use of sugammadex 2mg/kg for reversal of neuromuscular blocking agent. |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SugammadexAlso: bridion* 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. | Drug | Sugammadex |
| NeostigmineAlso: Neostigmine methylsulfate* 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. | Drug | Neostigmine |
Primary outcome
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)
8 secondary outcomes
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
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
modified lung ultrasound score at post-anesthesia care unit (PACU) (LUS_T2)
Time frame: 30 minutes after entering the post-anesthesia care unit (T2)
total recovery time (sec)
Time frame: From injection of neuromuscular block reversal agent to extubation, not to exceed 20 minutes
perioperative respiratory adverse events
Time frame: intraoperative
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
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
postoperative pulmonary complication
Time frame: from entering the general ward after surgery to discharge from hospital, up to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Derived from this study: PubMed 40625141Park JB, Kim TW, Ji SH, Jang YE, Kim EH, Kim JT, Kim HS, Lee JH. Ultrasonographic assessment of sugammadex-enhanced early recovery of diaphragmatic function in children: A randomised double-blind controlled trial. Eur J Anaesthesiol. 2025 Oct 1;42(10):907-915. doi: 10.1097/EJA.0000000000002231. Epub 2025 Jul 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugammadex and Neostigmine in people with Neuromuscular Block, Residual, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragm excursion ratio (time frame: during diaphragm ultrasound procedure after reversal of neuromuscular blocking agent (T1), an average of 10 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05724550, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.