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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

April 30, 2008
August 22, 2013
April 2007
January 2009   (final data collection date for primary outcome measure)
Motor Evoked Potential Amplitude [ Time Frame: baseline, 30 minutes ] [ Designated as safety issue: Yes ]
The primary outcome measure of the study was the participants who had Motor Evoked Potentials Amplitude significantly reduced (more than 70%)compared to the baseline.
the amplitude of (TcMEP) relative to baseline [ Time Frame: time of placement the first instrument in the spine ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00671931 on ClinicalTrials.gov Archive Site
Not Provided
(a) Arterial blood pressure, heart rate and somatosensory evoked potentials amplitude (SSE [ Time Frame: time of dexmedetomidine loading ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Susceptibility of Motor-Evoked Potentials to Varying Targeted Blood Levels of Dexmedetomidine
Susceptibility of Motor-Evoked Potentials to Varying Targeted Blood Levels of Dexmedetomidine

Reduction of the spinal cord injuries during scoliosis surgery is a major goal of the anesthesia and surgical team. Despite improvement in scoliosis surgery over the years, the development of neurological deficits remains the most feared complication of spine surgery. During scoliosis surgery it is very important to monitor the spinal cord to detect spinal cord injury with surgical manipulation. Continuous or intermittent intraoperative electrophysiological monitoring (neuron-monitoring) is used routinely during these procedures to provide the surgeon with information concerning the integrity of neurological structures at risk. All neuron-monitoring modalities are affected by the anesthetic regimen used. Of the various intravenous anesthetic drugs, the combination of propofol, remifentanil and dexmedetomidine appear to impact neuron-monitoring the least. The current anesthetic practice is to use the three drugs in combination at doses that do not depress the signals but there is no data relating targeted dexmedetomidine and propofol blood levels to neuron-monitoring signals. The lack of data results in wide variability in dosing with consequent variability in patient response.

Hypothesis: Clinically relevant blood levels of dexmedetomidine will affect the amplitude of transcranial motor-evoked potentials (TcMEP) either independently or by interaction with propofol in a dose dependent manner.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Open Label
Scoliosis
  • Drug: low dexmedetomidine, low propofol
    Dexmedetomidine loading dose 0.6 MCG/KG,Propofol infusion 100 MCG/KG/M
  • Drug: high dexmedetomidine, low propofol
    Dexmedetomidine loading dose 1.1 MCG/KG ,Propofol infusion 100 MCG/KG/M
  • Drug: Dexmedetomidine
    Dexmedetomidine loading dose 0.6 MCG/KG,Propofol infusion 200 MCG/KG/M
  • Drug: Dexmedetomidin
    Dexmedetomidine loading dose 1.1 MCG/KG.Propofol infusion 200 MCG/KG/M
  • Drug: Dexmedetomidine
    Dexmedetomidine loading dose 0.9 mcg/kg,Propofol infusion 140 mcg/kg/min
  • Active Comparator: I
    Dexmedetomidine low infusion, Propofol low infusion
    Intervention: Drug: low dexmedetomidine, low propofol
  • Active Comparator: II
    Dexmedetomidine high infusion, Propofol low infusion
    Intervention: Drug: high dexmedetomidine, low propofol
  • Active Comparator: IV
    Dexmedetomidine high infusion, Propofol high infusion
    Intervention: Drug: Dexmedetomidin
  • Active Comparator: V
    Dexmedetomidine intermediate infusion, Propofol intermediate infusion
    Intervention: Drug: Dexmedetomidine
  • Active Comparator: III
    Dexmedetomidine low infusion, Propofol high infusion
    Intervention: Drug: Dexmedetomidine
Mahmoud M, Sadhasivam S, Salisbury S, Nick TG, Schnell B, Sestokas AK, Wiggins C, Samuels P, Kabalin T, McAuliffe J. Susceptibility of transcranial electric motor-evoked potentials to varying targeted blood levels of dexmedetomidine during spine surgery. Anesthesiology. 2010 Jun;112(6):1364-73. doi: 10.1097/ALN.0b013e3181d74f55.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
January 2009
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects must be 10 to 25 years of age
  • Diagnosis of idiopathic scoliosis is established
  • Subject's legal authorized representative has given written, informed consent to participate in the study and, where appropriate, the subject has given assent to participate
  • American society of Anesthesiology physical status one/two
  • Patients scheduled for posterior spinal fusion only

Exclusion Criteria:

  • • Patients with neuromuscular scoliosis and patients with motor or sensory deficit in the lower extremities

    • Patients with allergy to, or contraindication for the drugs or techniques used in the study
    • Morbid obesity (Body mass index higher than 40)
    • History of malignant hyperthermia
    • Patient with severe cardiopulmonary disease (pulmonary hypertension, cardiomyopathy, mechanical ventilation)
Both
10 Years to 25 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00671931
06-09-12
Yes
Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
Not Provided
Principal Investigator: Mohamed Mahmoud, MD Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP