Postoperative Residual CurarizationNCT05760560
Incidence of Postoperative Residual Neuromuscular Blockade in the Era of Sugammadex
An observational study of Postoperative Residual Curarization, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study is a prospective observational study. A total 52 patients will be included in this study. We will observe the incidence of postoperative residual neuromuscular blockade in patients receiving sugammadex. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Postoperative Residual Curarization
- What is being tested?
- Sugammadex
- How many people
- 52 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Mar 2023to 31 Aug 2024
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective surgery under general anesthesia will be screened and included in this study.
Who may be able to join
- Patients undergoing elective surgery under general anesthesia.
- American Society of Anesthesiologists grade 1, 2, or 3.
- Aged >18 years
Who cannot join
- Refusal to participate in the study
- Body Mass Index < 18.5 kg/m2 or > 35 kg/m2
- History of neuromuscular disease.
- History of allergy to neuromuscular blockade
- Scheduled to transfer to the intensive care unit
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Chang-Hoon Koo, MD, PhD
About this study
This study is a prospective observational study. A total 52 patients will be included in this study. We will observe the incidence of postoperative residual neuromuscular blockade in patients receiving sugammadex.
- Conditions
- Postoperative Residual Curarization
- Being tested
- Sugammadex
- 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
At the end of surgery, neuromucular blockade will be reversed with 2mg/kg or 4mg/kg sugammadex depending on the depth of neuromuscular blockade.
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative residual neuromuscular blockade
TOF ratio < 0.9
Measured: On the arrival of PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start15 Mar 2023
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2024 (estimated)
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 Postoperative Residual CurarizationStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-Hoon Koo, Seoul National University Hospital
- Investigators
- Chang-Hoon Koo, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760560
- Sponsor's protocol ID
- TOF-Sugammadex
- Status last verified
- Apr 2023
- First submitted
- 26 Feb 2023
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Koo CH, Lee S, Yim S, Bae YK, Park I, Oh AY. Is quantitative neuromuscular monitoring mandatory after administration of the recommended dose of sugammadex? A prospective observational study. Anaesth Crit Care Pain Med. 2024 Dec;43(6):101445. doi: 10.1016/j.accpm.2024.101445. Epub 2024 Oct 16.
PubMed 39419348
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Postoperative Residual Neuromuscular Blockade in the Era of Sugammadex
- ClinicalTrials.gov ID
- NCT05760560
- Acronym / sponsor ID
- TOF-Sugammadex
- Conditions
- Postoperative Residual Curarization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 8 Mar 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 a prospective observational study. A total 52 patients will be included in this study. We will observe the incidence of postoperative residual neuromuscular blockade in patients receiving sugammadex.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective surgery under general anesthesia will be screened and included in this study.
Key inclusion criteria (3 listed)
- Patients undergoing elective surgery under general anesthesia.
- American Society of Anesthesiologists grade 1, 2, or 3.
- Aged >18 years
Key exclusion criteria (5 listed)
- Refusal to participate in the study
- Body Mass Index < 18.5 kg/m2 or > 35 kg/m2
- History of neuromuscular disease.
- History of allergy to neuromuscular blockade
- Scheduled to transfer to the intensive care unit
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 |
|---|---|---|
| SugammadexAt the end of surgery, neuromucular blockade will be reversed with 2mg/kg or 4mg/kg sugammadex depending on the depth of neuromuscular blockade. | Drug | – |
Primary outcome
Postoperative residual neuromuscular blockade
Time frame: On the arrival of PACU
TOF ratio < 0.9
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Derived from this study: PubMed 39419348Koo CH, Lee S, Yim S, Bae YK, Park I, Oh AY. Is quantitative neuromuscular monitoring mandatory after administration of the recommended dose of sugammadex? A prospective observational study. Anaesth Crit Care Pain Med. 2024 Dec;43(6):101445. doi: 10.1016/j.accpm.2024.101445. Epub 2024 Oct 16.
- 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.
Chang-Hoon Koo principal investigator
Seoul National University Bundang Hospital
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 Postoperative Residual Curarization, 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chang-Hoon Koo (+821085098841, vollock9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative residual neuromuscular blockade (time frame: On the arrival of PACU). 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 NCT05760560, 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 14 Apr 2023.