BurnsPhase 3NCT03513406
Comparison of Reversal of Neuromuscular Blockade With Sugammadex Versus Neostigmine Plus Glycopyrolate in Patients Undergoing Burn Surgery
A Phase 3 study testing Sugammadex, Neostigmine and Glycopyrrolate in people with Burns, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to learn if there is a difference in recovery time when using sugammadex versus neostigmine. The researchers also hope to add further knowledge and data to the safety of using sugammadex in burn patients who are hypermetabolic. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Burns
- What is being tested?
- Sugammadex, Neostigmine and Glycopyrrolate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2018to 7 Mar 2023
- Phase
- Phase 3
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing burn surgery under general anesthesia
Who cannot join
- Patients without a non-burned upper extremity
- Renal insufficiency or failure
- Sensitivity or hypersensitivity reaction to sugammadex
- Liver impairment, neuromuscular degenerative disease or dependence on drugs or alcohol
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
The purpose of this study is to learn if there is a difference in recovery time when using sugammadex versus neostigmine. The researchers also hope to add further knowledge and data to the safety of using sugammadex in burn patients who are hypermetabolic.
- Conditions
- Burns
- Being tested
- Sugammadex, Neostigmine, Glycopyrrolate
- Keywords
- muscle function
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
Sugammadex is indicated for the reversal of neuromuscular blockade.
NeostigmineDrug
Neostigmine is indicated for the reversal of neuromuscular blockade.
GlycopyrrolateDrug
Glycopyrrolate is used in conjunction with neostigmine to prevent neostigmine's muscarinic effects.
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex | Active comparator | Muscle relaxant reversal will be attained with sugammadex 2 mg/kgm IV. Receives: Drug: Sugammadex |
| Neostigmine | Active comparator | Muscle relaxant reversal will be attained with neostigmine 50 mcg/kgm plus glycopyrrolate10 mcg/kgm IV. Receives: Drug: Neostigmine; Drug: Glycopyrrolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to return to a 90% Train of Four (TOF) neuromuscular twitch
Measured: Within 24 hours after surgery
Secondary outcomes (2)
Time to endotracheal extubation
Measured: Within 24 hours after surgery
Time to discharge from the operating room
Measured: Within 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start15 Mar 2018
- Primary completion7 Mar 2023
- Study completion7 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony Kovac, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513406
- Sponsor's protocol ID
- STUDY00141829
- Status last verified
- Sep 2023
- First submitted
- 19 Apr 2018
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Reversal of Neuromuscular Blockade With Sugammadex Versus Neostigmine Plus Glycopyrolate in Patients Undergoing Burn Surgery
- ClinicalTrials.gov ID
- NCT03513406
- Acronym / sponsor ID
- STUDY00141829
- Conditions
- Burns
- Keywords
- muscle function
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 7 Mar 2023 (actual)
- First posted
- 1 May 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.
The purpose of this study is to learn if there is a difference in recovery time when using sugammadex versus neostigmine. The researchers also hope to add further knowledge and data to the safety of using sugammadex in burn patients who are hypermetabolic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugammadex | Active comparator | Drug: SugammadexMuscle relaxant reversal will be attained with sugammadex 2 mg/kgm IV. |
| Neostigmine | Active comparator | Drug: Neostigmine, Drug: GlycopyrrolateMuscle relaxant reversal will be attained with neostigmine 50 mcg/kgm plus glycopyrrolate10 mcg/kgm IV. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing burn surgery under general anesthesia
Key exclusion criteria (4 listed)
- Patients without a non-burned upper extremity
- Renal insufficiency or failure
- Sensitivity or hypersensitivity reaction to sugammadex
- Liver impairment, neuromuscular degenerative disease or dependence on drugs or alcohol
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 |
|---|---|---|
| SugammadexSugammadex is indicated for the reversal of neuromuscular blockade. | Drug | Sugammadex |
| NeostigmineNeostigmine is indicated for the reversal of neuromuscular blockade. | Drug | Neostigmine |
| GlycopyrrolateGlycopyrrolate is used in conjunction with neostigmine to prevent neostigmine's muscarinic effects. | Drug | Neostigmine |
Primary outcome
Time to return to a 90% Train of Four (TOF) neuromuscular twitch
Time frame: Within 24 hours after surgery
2 secondary outcomes
Time to endotracheal extubation
Time frame: Within 24 hours after surgery
Time to discharge from the operating room
Time frame: Within 24 hours after surgery
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 28 Sep 2023.
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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.
Anthony Kovac, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sugammadex, Neostigmine and Glycopyrrolate in people with Burns, run by University of Kansas Medical Center at 1 site in United States.
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 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 28 Sep 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 United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to return to a 90% Train of Four (TOF) neuromuscular twitch (time frame: Within 24 hours after 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 28 Sep 2023.