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Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01645098
Recruitment Status : Completed
First Posted : July 20, 2012
Results First Posted : February 26, 2015
Last Update Posted : February 26, 2015
Sponsor:
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Duchenne Muscular Dystrophy
Interventions Drug: Ketamine
Drug: Dexmedetomidine
Enrollment 53
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dexmedetomidine 1 mcg/kg Dexmedetomidine 0.5 mcg/kg
Hide Arm/Group Description

Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.

Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed

Dexmedetomidine: 0.5 mcg/kg/hr IV

Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.

Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed

Dexmedetomidine: 0.5 mcg/kg/hr IV

Period Title: Overall Study
Started 24 29
Completed 24 29
Not Completed 0 0
Arm/Group Title Dexmedetomidine 1 mcg/kg Dexmedetomidine 0.5 mcg/kg Total
Hide Arm/Group Description

Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.

Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed

Dexmedetomidine: 0.5 mcg/kg/hr IV

Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.

Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed

Dexmedetomidine: 0.5 mcg/kg/hr IV

Total of all reporting groups
Overall Number of Baseline Participants 24 29 53
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 29 participants 53 participants
9.7  (1.4) 8.9  (1.9) 9.4  (1.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 29 participants 53 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
24
 100.0%
29
 100.0%
53
 100.0%
1.Primary Outcome
Title Time to Sedation Score of 3-4
Hide Description 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.
Time Frame Immediately prior to incision
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine 1 mcg/kg Dexmedetomidine 0.5 mcg/kg
Hide Arm/Group Description:

Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.

Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed

Dexmedetomidine: 0.5 mcg/kg/hr IV

Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.

Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed

Dexmedetomidine: 0.5 mcg/kg/hr IV

Overall Number of Participants Analyzed 24 29
Mean (Standard Deviation)
Unit of Measure: minutes
3.7  (2.3) 2.8  (1.6)
2.Secondary Outcome
Title Heart Rate Change After Dexmedetomidine Loading Dose
Hide Description Difference in heart rate from baseline to immediately following infusion of dexmedetomidine loading dose.
Time Frame Baseline to immediately post dexmedetomidine infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine 1 mcg/kg Dexmedetomidine 0.5 mcg/kg
Hide Arm/Group Description:

Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.

Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed

Dexmedetomidine: 0.5 mcg/kg/hr IV

Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.

Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed

Dexmedetomidine: 0.5 mcg/kg/hr IV

Overall Number of Participants Analyzed 24 29
Mean (Standard Deviation)
Unit of Measure: BPM
-13  (13) -5  (10)
3.Secondary Outcome
Title Mean Arterial Pressure (MAP) Change After Dexmedetomidine Loading Dose
Hide Description Change in MAP from baseline measurement to immediately post dexmedetomidine infusion measured via blood pressure cuff.
Time Frame Baseline to immediately post dexmedetomidine infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine 1 mcg/kg Dexmedetomidine 0.5 mcg/kg
Hide Arm/Group Description:

Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.

Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed

Dexmedetomidine: 0.5 mcg/kg/hr IV

Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.

Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed

Dexmedetomidine: 0.5 mcg/kg/hr IV

Overall Number of Participants Analyzed 24 29
Mean (Standard Deviation)
Unit of Measure: mmHg
9  (10) 5  (8)
4.Secondary Outcome
Title Oxygen Saturation Change After Dexmedetomidine Loading Dose
Hide Description Change in oxygen saturation from baseline measurement to immediately post dexmedetomidine infusion.
Time Frame Baseline to immediately post dexmedetomidine infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine 1 mcg/kg Dexmedetomidine 0.5 mcg/kg
Hide Arm/Group Description:

Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.

Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed

Dexmedetomidine: 0.5 mcg/kg/hr IV

Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.

Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed

Dexmedetomidine: 0.5 mcg/kg/hr IV

Overall Number of Participants Analyzed 24 29
Mean (Standard Deviation)
Unit of Measure: percentage of oxygen
-0.3  (1.2) 0.4  (0.7)
5.Secondary Outcome
Title EtCO2 Change After Dexmedetomidine Loading Dose
Hide Description Change in end-tidal carbon dioxide from baseline measurement to immediately post dexmedetomidine infusion.
Time Frame Baseline to immediately post dexmedetomidine infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine 1 mcg/kg Dexmedetomidine 0.5 mcg/kg
Hide Arm/Group Description:

Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.

Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed

Dexmedetomidine: 0.5 mcg/kg/hr IV

Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.

Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed

Dexmedetomidine: 0.5 mcg/kg/hr IV

Overall Number of Participants Analyzed 24 29
Mean (Standard Deviation)
Unit of Measure: mmHg
1  (5) 2  (6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dexmedetomidine 1 mcg/kg Dexmedetomidine 0.5 mcg/kg
Hide Arm/Group Description

Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.

Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed

Dexmedetomidine: 0.5 mcg/kg/hr IV

Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.

Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed

Dexmedetomidine: 0.5 mcg/kg/hr IV

All-Cause Mortality
Dexmedetomidine 1 mcg/kg Dexmedetomidine 0.5 mcg/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Dexmedetomidine 1 mcg/kg Dexmedetomidine 0.5 mcg/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/29 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dexmedetomidine 1 mcg/kg Dexmedetomidine 0.5 mcg/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/29 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Marco Corridore, MD
Organization: Nationwide Children's Hospital
Phone: 614-722-4200
EMail: Marco.Corridore@nationwidechildrens.org
Layout table for additonal information
Responsible Party: Joseph D. Tobias, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01645098    
Other Study ID Numbers: IRB11-00532
First Submitted: June 8, 2012
First Posted: July 20, 2012
Results First Submitted: February 4, 2015
Results First Posted: February 26, 2015
Last Update Posted: February 26, 2015