Trial Outcomes & Findings for Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy (NCT NCT01645098)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

53 participants

Primary outcome timeframe

Immediately prior to incision

Results posted on

2015-02-26

Participant Flow

Participant milestones

Participant milestones
Measure	Dexmedetomidine 1 mcg/kg 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	Dexmedetomidine 0.5 mcg/kg 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 Study STARTED	24	29
Overall Study COMPLETED	24	29
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexmedetomidine 1 mcg/kg n=24 Participants 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	Dexmedetomidine 0.5 mcg/kg n=29 Participants 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 n=53 Participants Total of all reporting groups
Age, Continuous	9.7 years STANDARD_DEVIATION 1.4 • n=5 Participants	8.9 years STANDARD_DEVIATION 1.9 • n=7 Participants	9.4 years STANDARD_DEVIATION 1.7 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	29 Participants n=7 Participants	53 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Dexmedetomidine 1 mcg/kg n=24 Participants 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	Dexmedetomidine 0.5 mcg/kg n=29 Participants 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
Time to Sedation Score of 3-4	3.7 minutes Standard Deviation 2.3	2.8 minutes Standard Deviation 1.6

SECONDARY outcome

Timeframe: Baseline to immediately post dexmedetomidine infusion.

Difference in heart rate from baseline to immediately following infusion of dexmedetomidine loading dose.

Outcome measures

Outcome measures
Measure	Dexmedetomidine 1 mcg/kg n=24 Participants 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	Dexmedetomidine 0.5 mcg/kg n=29 Participants 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
Heart Rate Change After Dexmedetomidine Loading Dose	-13 BPM Standard Deviation 13	-5 BPM Standard Deviation 10

SECONDARY outcome

Timeframe: Baseline to immediately post dexmedetomidine infusion.

Change in MAP from baseline measurement to immediately post dexmedetomidine infusion measured via blood pressure cuff.

Outcome measures

Outcome measures
Measure	Dexmedetomidine 1 mcg/kg n=24 Participants 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	Dexmedetomidine 0.5 mcg/kg n=29 Participants 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
Mean Arterial Pressure (MAP) Change After Dexmedetomidine Loading Dose	9 mmHg Standard Deviation 10	5 mmHg Standard Deviation 8

SECONDARY outcome

Timeframe: Baseline to immediately post dexmedetomidine infusion.

Change in oxygen saturation from baseline measurement to immediately post dexmedetomidine infusion.

Outcome measures

Outcome measures
Measure	Dexmedetomidine 1 mcg/kg n=24 Participants 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	Dexmedetomidine 0.5 mcg/kg n=29 Participants 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
Oxygen Saturation Change After Dexmedetomidine Loading Dose	-0.3 percentage of oxygen Standard Deviation 1.2	0.4 percentage of oxygen Standard Deviation 0.7

SECONDARY outcome

Timeframe: Baseline to immediately post dexmedetomidine infusion.

Change in end-tidal carbon dioxide from baseline measurement to immediately post dexmedetomidine infusion.

Outcome measures

Outcome measures
Measure	Dexmedetomidine 1 mcg/kg n=24 Participants 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	Dexmedetomidine 0.5 mcg/kg n=29 Participants 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
EtCO2 Change After Dexmedetomidine Loading Dose	1 mmHg Standard Deviation 5	2 mmHg Standard Deviation 6

Adverse Events

Dexmedetomidine 1 mcg/kg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dexmedetomidine 0.5 mcg/kg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marco Corridore, MD

Nationwide Children's Hospital

Phone: 614-722-4200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place