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Susceptibility of Motor-Evoked Potentials to Varying Targeted Blood Levels of Dexmedetomidine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00671931
First received: April 30, 2008
Last updated: August 22, 2013
Last verified: August 2013
Results First Received: June 24, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Factorial Assignment;   Masking: Open Label
Condition: Scoliosis
Interventions: Drug: low dexmedetomidine, low propofol
Drug: high dexmedetomidine, low propofol
Drug: Dexmedetomidine
Drug: Dexmedetomidin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment has been completed for this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There is no wash out, run-in, or transition period in this protocol

Reporting Groups
  Description
Low Dexmedetomidine/Low Propofol

Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.

TABLE 2: dexmedetomidine and propofol dose schedule.

Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75

High Dexmedetomidine/Low Propofol

Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.

TABLE 2: dexmedetomidine and propofol dose schedule.

Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75

Low Dexmedetomidine/High Propofol

Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.

TABLE 2: dexmedetomidine and propofol dose schedule.

Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75

High Dexmedetomidine/High Propofol

Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.

TABLE 2: dexmedetomidine and propofol dose schedule.

Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75

Intermediate Dexmedetomidine/Intermediate Propofol

Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.

TABLE 2: dexmedetomidine and propofol dose schedule.

Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75


Participant Flow:   Overall Study
    Low Dexmedetomidine/Low Propofol     High Dexmedetomidine/Low Propofol     Low Dexmedetomidine/High Propofol     High Dexmedetomidine/High Propofol     Intermediate Dexmedetomidine/Intermediate Propofol  
STARTED     9     8     9     10     8  
COMPLETED     8 [1]   8 [2]   9 [2]   8 [3]   7 [4]
NOT COMPLETED     1     0     0     2     1  
Physician Decision                 1                 0                 0                 2                 1  
[1] Nueromonitoring equipment falure
[2] All completed
[3] Prepositioning - Neuromonitoring required
[4] Low heart rate requiring treatment



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Low Dexmedetomidine/Low Propofol

Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.

TABLE 2: dexmedetomidine and propofol dose schedule.

Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75

High Dexmedetomidine/Low Propofol

Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.

TABLE 2: dexmedetomidine and propofol dose schedule.

Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75

Low Dexmedetomidine/High Propofol

Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.

TABLE 2: dexmedetomidine and propofol dose schedule.

Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75

High Dexmedetomidine/High Propofol

Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.

TABLE 2: dexmedetomidine and propofol dose schedule.

Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75

Intermediate Dexmedetomidine/Intermediate Propofol

Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.

TABLE 2: dexmedetomidine and propofol dose schedule.

Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (** ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75

Total Total of all reporting groups

Baseline Measures
    Low Dexmedetomidine/Low Propofol     High Dexmedetomidine/Low Propofol     Low Dexmedetomidine/High Propofol     High Dexmedetomidine/High Propofol     Intermediate Dexmedetomidine/Intermediate Propofol     Total  
Number of Participants  
[units: participants]
  9     8     9     10     8     44  
Age  
[units: participants]
           
<=18 years     8     8     9     10     8     43  
Between 18 and 65 years     1     0     0     0     0     1  
>=65 years     0     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  16  ± 2     15  ± 2     15  ± 2     15  ± 2     15  ± 2     15  ± 2  
Gender  
[units: participants]
           
Female     4     6     9     9     7     35  
Male     5     2     0     1     1     9  
Region of Enrollment  
[units: participants]
           
United States     9     8     9     10     8     44  



  Outcome Measures

1.  Primary:   Motor Evoked Potential Amplitude   [ Time Frame: baseline, 30 minutes ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Mohamed Mahmoud, MD Principal Investigator
Organization: Cincinnati Children's Hospital
phone: 513 636-7426
e-mail: mohamed.mahmoud@cchmc.org


Publications of Results:

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00671931     History of Changes
Other Study ID Numbers: 06-09-12
Study First Received: April 30, 2008
Results First Received: June 24, 2011
Last Updated: August 22, 2013
Health Authority: United States: Food and Drug Administration