Muscle RelaxantsNCT02157545
The Dose-Response Relationship of Rocuronium in Patients Taking Pyridostigmine
An observational study of Muscle Relaxants, run by Shashi Bhatt, MD at 1 site in United States.
Trial summary
Pyridostigmine is a medication that is used in certain heart rate and blood pressure conditions. This medication, as a side effect, is known to also cause changes in the junction between a nerve and muscle. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Muscle Relaxants
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to May 2016
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects taking pyridostigmine for any reason who are scheduled for surgery under general anesthia.
Who may be able to join
- Patients who take pyridostigmine for any reason or those who are matched by age, sex and weight to subjects taking pyridostigmine
- Patients who will be administered rocuronium during elective procedures as standard clinical care.
Who cannot join
- Allergy to rocuronium
- Known neuromuscular disorder, patients suffering from myasthenia gravis
- Subjects taking medications known to impact neuromuscular transmission (ex. gentamicin).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Toledo, Health Science Campus
Toledo, Ohio, 43614
About this study
Official title: The Dose-response Relationship of Rocuronium in Patients Taking Pyridostigmine Preoperatively Compared With Age and Sex Matched Controls
Pyridostigmine is a medication that is used in certain heart rate and blood pressure conditions. This medication, as a side effect, is known to also cause changes in the junction between a nerve and muscle. The changes caused at the nerve muscle junction by pyridostigmine could alter the effect of muscle relaxants (a medication used during surgery and anesthesia). The investigators are conducting this study to see whether patients taking pyridostigmine are more or less sensitive to rocuronium (a muscle relaxing medication used during surgery).
Read the detailed description
No subjects enrolled. No data collected.
- Conditions
- Muscle Relaxants
- Keywords
- muscle relaxants, pyridostigmine, pharmacodynamics, potency
- Medical subject headings
- Muscle Hypotonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pyridostigmine | administration of rocuronium to determine its potency. | |
| control arm (no pyridostigmine) | determination of potency of rocuronium in patients not taking pyridostigmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose of the muscle relaxant rocuronium that will lead to 50% decrease in the force of the evoked muscle contraction in patients taking pyridostigmine.
Rocuronium used to produce muscle weakness or paralysis during surgery. Its potency is measured as ED50, the dose necessary to cause a 50% reduction in the force of evoked muscle contraction. We intend to determine this measure of potency (ED50 for rocuronium) in patients taking pyridostigmine and compare it with control subjects.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: No eligible subjects identified. Study closed with IRB.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle RelaxantsStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shashi Bhatt, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shashi Bhatt, MD, University of Toledo Health Science Campus
- Investigators
- Shashi Bhatt, MD, Principal investigator, University of Toledo Health Science Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157545
- Sponsor's protocol ID
- Pyridostigmine
- Status last verified
- Jul 2016
- First submitted
- 21 May 2014
- Last updated
- 19 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No data collected.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dose-response Relationship of Rocuronium in Patients Taking Pyridostigmine Preoperatively Compared With Age and Sex Matched Controls
- ClinicalTrials.gov ID
- NCT02157545
- Acronym / sponsor ID
- Pyridostigmine
- Conditions
- Muscle Relaxants
- Keywords
- muscle relaxants, pyridostigmine, pharmacodynamics, potency
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No eligible subjects identified. Study closed with IRB.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shashi Bhatt, MDUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 6 Jun 2014 (estimated)
- 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.
Pyridostigmine is a medication that is used in certain heart rate and blood pressure conditions. This medication, as a side effect, is known to also cause changes in the junction between a nerve and muscle. The changes caused at the nerve muscle junction by pyridostigmine could alter the effect of muscle relaxants (a medication used during surgery and anesthesia). The investigators are conducting this study to see whether patients taking pyridostigmine are more or less sensitive to rocuronium (a muscle relaxing medication used during surgery).
Detailed description
No subjects enrolled. No data collected.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pyridostigmine | – | –administration of rocuronium to determine its potency. |
| control arm (no pyridostigmine) | – | –determination of potency of rocuronium in patients not taking pyridostigmine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects taking pyridostigmine for any reason who are scheduled for surgery under general anesthia.
Key inclusion criteria (2 listed)
- Patients who take pyridostigmine for any reason or those who are matched by age, sex and weight to subjects taking pyridostigmine
- Patients who will be administered rocuronium during elective procedures as standard clinical care.
Key exclusion criteria (3 listed)
- Allergy to rocuronium
- Known neuromuscular disorder, patients suffering from myasthenia gravis
- Subjects taking medications known to impact neuromuscular transmission (ex. gentamicin).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dose of the muscle relaxant rocuronium that will lead to 50% decrease in the force of the evoked muscle contraction in patients taking pyridostigmine.
Time frame: 12 months
Rocuronium used to produce muscle weakness or paralysis during surgery. Its potency is measured as ED50, the dose necessary to cause a 50% reduction in the force of evoked muscle contraction. We intend to determine this measure of potency (ED50 for rocuronium) in patients taking pyridostigmine and compare it with control subjects.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2016.
- Individual participant dataSharing planned: No. No data collected.
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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.
Shashi Bhatt, MD principal investigator
University of Toledo Health Science Campus
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 Muscle Relaxants, run by Shashi Bhatt, MD 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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 19 Jul 2016. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Dose of the muscle relaxant rocuronium that will lead to 50% decrease in the force of the evoked muscle contraction in patients taking pyridostigmine. (time frame: 12 months). 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 19 Jul 2016.