Duchenne Muscular DystrophyNCT01645098
Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy
A study testing Ketamine and Dexmedetomidine in people with Duchenne Muscular Dystrophy, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
This is an interventional study on Duchenne muscular dystrophy patients who will be receiving sedation for a muscle biopsy as part of another study. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Duchenne Muscular Dystrophy
- What is being tested?
- Ketamine and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing a muscle biopsy for IRB11-00203.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
This is an interventional study on Duchenne muscular dystrophy patients who will be receiving sedation for a muscle biopsy as part of another study.
- Conditions
- Duchenne Muscular Dystrophy
- Being tested
- Ketamine, Dexmedetomidine
- Medical subject headings
- Muscular Dystrophy, Duchenne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
1 mg/kg IV, additional doses of 0.5 mg/kg as needed
DexmedetomidineDrug
0.5 mcg/kg/hr IV
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine 1 mcg/kg | Experimental | Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr. Receives: Drug: Ketamine; Drug: Dexmedetomidine |
| Dexmedetomidine 0.5 mcg/kg | Experimental | Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr. Receives: Drug: Ketamine; Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Sedation Score of 3-4
The depth of sedation was judged using the University of Michigan Sedation Scale (UMSS). The score ranges from zero, awake and alert, to four, unarousable. A score of three, deeply sedated, or more was considered to be an appropriate level of sedation for the procedure.
Measured: Immediately prior to incision
Secondary outcomes (4)
Heart Rate Change After Dexmedetomidine Loading Dose
Difference in heart rate from baseline to immediately following infusion of dexmedetomidine loading dose.
Measured: Baseline to immediately post dexmedetomidine infusion.
Mean Arterial Pressure (MAP) Change After Dexmedetomidine Loading Dose
Change in MAP from baseline measurement to immediately post dexmedetomidine infusion measured via blood pressure cuff.
Measured: Baseline to immediately post dexmedetomidine infusion.
Oxygen Saturation Change After Dexmedetomidine Loading Dose
Change in oxygen saturation from baseline measurement to immediately post dexmedetomidine infusion.
Measured: Baseline to immediately post dexmedetomidine infusion.
EtCO2 Change After Dexmedetomidine Loading Dose
Change in end-tidal carbon dioxide from baseline measurement to immediately post dexmedetomidine infusion.
Measured: Baseline to immediately post dexmedetomidine infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startAug 2011
- Primary completionApr 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Duchenne Muscular DystrophyStudies of the same condition, open and under way.
- More trials run by Nationwide Children's 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph D. Tobias, Nationwide Children's Hospital
- Investigators
- Joseph D Tobias, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01645098
- Sponsor's protocol ID
- IRB11-00532
- Status last verified
- Feb 2015
- First submitted
- 8 Jun 2012
- Last updated
- 26 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT01645098
- Acronym / sponsor ID
- IRB11-00532
- Conditions
- Duchenne Muscular Dystrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 20 Jul 2012 (estimated)
- Results
- Posted 26 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an interventional study on Duchenne muscular dystrophy patients who will be receiving sedation for a muscle biopsy as part of another study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine 1 mcg/kg | Experimental | Drug: Ketamine, Drug: DexmedetomidinePatients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr. |
| Dexmedetomidine 0.5 mcg/kg | Experimental | Drug: Ketamine, Drug: DexmedetomidinePatients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing a muscle biopsy for IRB11-00203.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Ketamine1 mg/kg IV, additional doses of 0.5 mg/kg as needed | Drug | Dexmedetomidine 0.5 mcg/kg, Dexmedetomidine 1 mcg/kg |
| Dexmedetomidine0.5 mcg/kg/hr IV | Drug | Dexmedetomidine 0.5 mcg/kg, Dexmedetomidine 1 mcg/kg |
Primary outcome
Time to Sedation Score of 3-4
Time frame: Immediately prior to incision
The depth of sedation was judged using the University of Michigan Sedation Scale (UMSS). The score ranges from zero, awake and alert, to four, unarousable. A score of three, deeply sedated, or more was considered to be an appropriate level of sedation for the procedure.
4 secondary outcomes
Heart Rate Change After Dexmedetomidine Loading Dose
Time frame: Baseline to immediately post dexmedetomidine infusion.
Mean Arterial Pressure (MAP) Change After Dexmedetomidine Loading Dose
Time frame: Baseline to immediately post dexmedetomidine infusion.
Oxygen Saturation Change After Dexmedetomidine Loading Dose
Time frame: Baseline to immediately post dexmedetomidine infusion.
EtCO2 Change After Dexmedetomidine Loading Dose
Time frame: Baseline to immediately post dexmedetomidine infusion.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Joseph D Tobias, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine and Dexmedetomidine in people with Duchenne Muscular Dystrophy, run by Nationwide Children's Hospital 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 0 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 26 Feb 2015. 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?
Yes. Results are posted in the registry (first posted 26 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Sedation Score of 3-4 (time frame: Immediately prior to incision). 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 26 Feb 2015.