Supraglottic Airway Device InsertionNCT04545099
Comparison of the Impacts of Sugammadex With Neostigmine on Patency of Laryngeal Opening (Glottic Aperture Angle)
A study testing Sugammadex and Neostigmine in people with Supraglottic Airway Device Insertion, run by Yonsei University.
Trial summary
The aim of this study is to compare the degree of change in the angle of the vocal cords before and after administration of neostigmine or sugammadex. Moreover, we intend to compare the angle of vocal folds after administration of neostigmine or sugammadex. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Supraglottic Airway Device Insertion
- What is being tested?
- Sugammadex and Neostigmine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Sep 2020to Sep 2022
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Adult patients who undergoes elective surgery under general anesthesia with supraglottic airway device.
Who cannot join
- Patients under 20 years old
- Pregnant women
- Patients who can not read the consent form or are not fluent in Korean (illiterate, foreigner)
- Patients who refused the clinical trial
- Patients with dementia or cognitive impairment
- Patients with neuromuscular disorders impairing neuromuscular blockade
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- Renal dysfunction (estimated Glomerular Filtration Rate less than 30 ml/min/1.73m2)
- Past history of allergic reactions to neostigmine or sugammadex
- Patients with ASA class IV or higher
- Robotic surgery, adenoid or tonsillectomy
- Patients with moderate or severe asthma, pulmonary function tests with forced expiratory volume for 1second of 1 liter or less, patients with upper respiratory infection symptoms within 2 weeks before surgery, current smokers (within 1 month of smoking cessation is included.)
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this study is to compare the degree of change in the angle of the vocal cords before and after administration of neostigmine or sugammadex. Moreover, we intend to compare the angle of vocal folds after administration of neostigmine or sugammadex.
- Conditions
- Supraglottic Airway Device Insertion
- Being tested
- Sugammadex, Neostigmine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
Administration of Sugammadex for muscle relaxation reversal
NeostigmineDrug
Administration of Neostigmine for muscle relaxation reversal
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex | Experimental | Administration of Sugammadex Receives: Drug: Sugammadex |
| Neostigmine | Active comparator | Administration of Neostigmine Receives: Drug: Neostigmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angle of vocal folds after administration of sugammadex or neostigmine 2) Degree of change in angle of vocal folds before and after administration of sugammadex or neostigmine
Measured: 1-2 minutes after drug administration (inhalation, exhalation)
Degree of change in angle of vocal folds before and after administration of sugammadex or neostigmine
Measured: 1) Just before drug administration 2) 1-2 minutes after drug administration (inhalation, exhalation)
Secondary outcomes (2)
Time to recover from spontaneous breathing
Time taken to recover from spontaneous breathing(6ml/kg or more) after administration of sugammadex or neostigmine
Measured: immediately after drug(sugammadex or neostigmine) administration
Time to extubation
Time taken to extubation after administration of sugammadex or neostigmine
Measured: immediately after drug(sugammadex or neostigmine) administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study startSep 2020 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraglottic Airway Device InsertionStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeong-Rim Lee, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04545099
- Sponsor's protocol ID
- 4-2020-0804
- Status last verified
- Sep 2020
- First submitted
- 1 Sep 2020
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Impacts of Sugammadex With Neostigmine on Patency of Laryngeal Opening (Glottic Aperture Angle)
- ClinicalTrials.gov ID
- NCT04545099
- Acronym / sponsor ID
- 4-2020-0804
- Conditions
- Supraglottic Airway Device Insertion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 10 Sep 2020 (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.
The aim of this study is to compare the degree of change in the angle of the vocal cords before and after administration of neostigmine or sugammadex. Moreover, we intend to compare the angle of vocal folds after administration of neostigmine or sugammadex.
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 |
|---|---|---|
| Sugammadex | Experimental | Drug: SugammadexAdministration of Sugammadex |
| Neostigmine | Active comparator | Drug: NeostigmineAdministration of Neostigmine |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Adult patients who undergoes elective surgery under general anesthesia with supraglottic airway device.
Key exclusion criteria (11 listed)
- Patients under 20 years old
- Pregnant women
- Patients who can not read the consent form or are not fluent in Korean (illiterate, foreigner)
- Patients who refused the clinical trial
- Patients with dementia or cognitive impairment
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 |
|---|---|---|
| SugammadexAdministration of Sugammadex for muscle relaxation reversal | Drug | Sugammadex |
| NeostigmineAdministration of Neostigmine for muscle relaxation reversal | Drug | Neostigmine |
Primary outcome
Angle of vocal folds after administration of sugammadex or neostigmine 2) Degree of change in angle of vocal folds before and after administration of sugammadex or neostigmine
Time frame: 1-2 minutes after drug administration (inhalation, exhalation)
Degree of change in angle of vocal folds before and after administration of sugammadex or neostigmine
Time frame: 1) Just before drug administration 2) 1-2 minutes after drug administration (inhalation, exhalation)
2 secondary outcomes
Time to recover from spontaneous breathing
Time frame: immediately after drug(sugammadex or neostigmine) administration
Time to extubation
Time frame: immediately after drug(sugammadex or neostigmine) administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
Jeong-Rim Lee principal investigator
Severance Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Sugammadex and Neostigmine in people with Supraglottic Airway Device Insertion, run by Yonsei University.
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 11 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 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Jeong-Rim Lee (82-2-2224-4135, MANYA@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angle of vocal folds after administration of sugammadex or neostigmine 2) Degree of change in angle of vocal folds before and after administration of sugammadex or neostigmine (time frame: 1-2 minutes after drug administration (inhalation, exhalation)). The study lists 2 primary outcomes in all. 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 10 Sep 2020.