Neuromuscular BlockadeNCT03775603
Comparison of TOFscan and TOF-Watch SX in Pediatric Neuromuscular Function Recovery
An observational study of Neuromuscular Blockade, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Comparison of TOFscan and TOF-Watch SX for monitoring of neuromuscular blockade function in children Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- TOFscan
- Type of treatment
- Medical device
- How many people
- 37 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Mar 2019to 30 Jan 2020
- Phase
- Observational
- 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 Up to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: general anesthesia with neuromuscular blockade in children
Who may be able to join
- patients need neuromuscular blockade
Who cannot join
- contraindication of rocuronium
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of TOFscan and TOF-Watch SX in Children
Comparison of TOFscan and TOF-Watch SX for monitoring of neuromuscular blockade function in children
Read the detailed description
TOF ratio of TOFscan when TOF-Watch SX shows TOF ratio 0.7 with rocuronium in children during general anesthesia
- Conditions
- Neuromuscular Blockade
- Being tested
- TOFscan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOFscanDevice
comparison of TOFscan over TOF-Watch SX
What is being measured
The primary outcome is the main question the study is designed to answer.
TOF ratio of TOFscan
value of TOF ratio of TOFscan at TOF ratio 0.7 of TOF-Watch SX during neuromuscular function recovery period
Measured: intraoperative during anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start2 Mar 2019
- Primary completion9 Jan 2020
- Study completion30 Jan 2020
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 BlockadeStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Soo Kim, Seoul National University Hospital
- Investigators
- Hee-Soo Kim, Principal investigator, Seoul National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775603
- Sponsor's protocol ID
- 1811-137-989
- Status last verified
- Apr 2020
- First submitted
- 12 Dec 2018
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yhim HB, Jang YE, Lee JH, Kim EH, Kim JT, Kim HS. Comparison of the TOFscan and the TOF-Watch SX during pediatric neuromuscular function recovery: a prospective observational study. Perioper Med (Lond). 2021 Dec 10;10(1):45. doi: 10.1186/s13741-021-00215-2.
PubMed 34886885
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of TOFscan and TOF-Watch SX in Children
- ClinicalTrials.gov ID
- NCT03775603
- Acronym / sponsor ID
- 1811-137-989
- Conditions
- Neuromuscular Blockade
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 2 Mar 2019 (actual)
- Primary completion
- 9 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 14 Dec 2018 (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.
Comparison of TOFscan and TOF-Watch SX for monitoring of neuromuscular blockade function in children
Detailed description
TOF ratio of TOFscan when TOF-Watch SX shows TOF ratio 0.7 with rocuronium in children during general anesthesia
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- general anesthesia with neuromuscular blockade in children
Key inclusion criteria (1 listed)
- patients need neuromuscular blockade
Key exclusion criteria (1 listed)
- contraindication of rocuronium
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 |
|---|---|---|
| TOFscancomparison of TOFscan over TOF-Watch SX | Device | – |
Primary outcome
TOF ratio of TOFscan
Time frame: intraoperative during anesthesia
value of TOF ratio of TOFscan at TOF ratio 0.7 of TOF-Watch SX during neuromuscular function recovery period
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 16 Apr 2020.
- Derived from this study: PubMed 34886885Yhim HB, Jang YE, Lee JH, Kim EH, Kim JT, Kim HS. Comparison of the TOFscan and the TOF-Watch SX during pediatric neuromuscular function recovery: a prospective observational study. Perioper Med (Lond). 2021 Dec 10;10(1):45. doi: 10.1186/s13741-021-00215-2.
- Individual participant dataSharing planned: No
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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.
Hee-Soo Kim principal investigator
Seoul National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Blockade, 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 1 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 16 Apr 2020. 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?
TOF ratio of TOFscan (time frame: intraoperative during anesthesia). 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 NCT03775603, 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 16 Apr 2020.