Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy

• 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: Nationwide Children's Hospital
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Dexmedetomidine 1 mcg/kg	Dexmedetomidine 0.5 mcg/kg
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

Baseline Characteristics

Arm/Group Title		Dexmedetomidine 1 mcg/kg	Dexmedetomidine 0.5 mcg/kg	Total
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
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%

Outcome Measures

1. Primary Outcome

Title	Time to Sedation Score of 3-4
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexmedetomidine 1 mcg/kg	Dexmedetomidine 0.5 mcg/kg
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
Description	Difference in heart rate from baseline to immediately following infusion of dexmedetomidine loading dose.
Time Frame	Baseline to immediately post dexmedetomidine infusion.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexmedetomidine 1 mcg/kg	Dexmedetomidine 0.5 mcg/kg
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
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexmedetomidine 1 mcg/kg	Dexmedetomidine 0.5 mcg/kg
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
Description	Change in oxygen saturation from baseline measurement to immediately post dexmedetomidine infusion.
Time Frame	Baseline to immediately post dexmedetomidine infusion.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexmedetomidine 1 mcg/kg	Dexmedetomidine 0.5 mcg/kg
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
Description	Change in end-tidal carbon dioxide from baseline measurement to immediately post dexmedetomidine infusion.
Time Frame	Baseline to immediately post dexmedetomidine infusion.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexmedetomidine 1 mcg/kg	Dexmedetomidine 0.5 mcg/kg
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)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Dexmedetomidine 1 mcg/kg	Dexmedetomidine 0.5 mcg/kg
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	--/--	--/--
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%)
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%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Marco Corridore, MD
• Organization: Nationwide Children's Hospital
• Phone: 614-722-4200
• EMail: Marco.Corridore@nationwidechildrens.org

• 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