N/A
N=53
Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy
Duchenne Muscular Dystrophy
Bottom Line
View on ClinicalTrials.gov: NCT01645098 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcome: Primary: Time to Sedation Score of 3-4 — 3.7; 2.8 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ketamine (Drug); Dexmedetomidine (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Male
- Sponsor
- Nationwide Children's Hospital
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Sedation Score of 3-4 |
3.7; 2.8 | — |
| SECONDARY Heart Rate Change After Dexmedetomidine Loading Dose |
-13; -5 | — |
| SECONDARY Mean Arterial Pressure (MAP) Change After Dexmedetomidine Loading Dose |
9; 5 | — |
| SECONDARY Oxygen Saturation Change After Dexmedetomidine Loading Dose |
-0.3; 0.4 | — |
| SECONDARY EtCO2 Change After Dexmedetomidine Loading Dose |
1; 2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients undergoing a muscle biopsy for IRB11-00203.
Data sourced from ClinicalTrials.gov (NCT01645098). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.