Recovery TimeNCT06745492
Low-dose Neostigmine at TOF Ratio of 0.7 Improves Neuromuscular Recovery
An observational study of Recovery Time, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study is a prospective observational study. A total of 54 patients were included in this study. We observed the time from neostigmine administration to TOF ratio of 1.0. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Recovery Time
- What is being tested?
- Neostigmine + Glycopyrrolate
- How many people
- 59 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2022to 25 Aug 2023
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective thyroid surgery under general anesthesia were screened and included in this study
Who may be able to join
- Patients undergoing elective thyroid surgery under general anesthesia
- a body mass index of 18.5-25 kg/m2
- Age ≥ 20
Who cannot join
- Refused to participate
- history of hypersensitivity to acetylcholinesterase inhibitor
- neuromuscular disease
- hepatic or renal dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low-dose Neostigmine at TOF Ratio of 0.7 Accelerates Neuromuscular Recovery Without Adverse Effects: a Prospective Observational Study
This study is a prospective observational study. A total of 54 patients were included in this study. We observed the time from neostigmine administration to TOF ratio of 1.0.
- Conditions
- Recovery Time
- Being tested
- Neostigmine + Glycopyrrolate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neostigmine + GlycopyrrolateDrug
a 20 mcg/kg of neostigmine and 4 mcg/kg of glycopyrrolate were administered at a TOF ratio of 0.7.
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery time
Time from neostigmine administration to TOF ratio of 1.0
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start1 Oct 2022
- Primary completion20 Aug 2023
- Study completion25 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recovery TimeStudies 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
- 59 participants (actual)
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 Bundang Hospital
- Investigators
- Chang-Hoon Koo, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745492
- Sponsor's protocol ID
- Neostigmine & TOFR 0.7
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Neostigmine at TOF Ratio of 0.7 Accelerates Neuromuscular Recovery Without Adverse Effects: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06745492
- Acronym / sponsor ID
- Neostigmine & TOFR 0.7
- Conditions
- Recovery Time
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 20 Aug 2023 (actual)
- Study completion
- 25 Aug 2023 (actual)
- First posted
- 20 Dec 2024 (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 of 54 patients were included in this study. We observed the time from neostigmine administration to TOF ratio of 1.0.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective thyroid surgery under general anesthesia were screened and included in this study
Key inclusion criteria (3 listed)
- Patients undergoing elective thyroid surgery under general anesthesia
- a body mass index of 18.5-25 kg/m2
- Age ≥ 20
Key exclusion criteria (4 listed)
- Refused to participate
- history of hypersensitivity to acetylcholinesterase inhibitor
- neuromuscular disease
- hepatic or renal dysfunction
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 |
|---|---|---|
| Neostigmine + Glycopyrrolatea 20 mcg/kg of neostigmine and 4 mcg/kg of glycopyrrolate were administered at a TOF ratio of 0.7. | Drug | – |
Primary outcome
Recovery time
Time frame: During surgery
Time from neostigmine administration to TOF ratio of 1.0
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 20 Dec 2024.
- 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 Recovery Time, 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 4 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 20 Dec 2024. 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?
Recovery time (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Dec 2024.