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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229
- Cincinati Children Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: I
Dexmedetomidine low infusion, Propofol low infusion
|
Dexmedetomidine loading dose 0.6 MCG/KG,Propofol infusion 100 MCG/KG/M
|
|
Active Comparator: II
Dexmedetomidine high infusion, Propofol low infusion
|
Dexmedetomidine loading dose 1.1 MCG/KG ,Propofol infusion 100 MCG/KG/M
|
|
Active Comparator: IV
Dexmedetomidine high infusion, Propofol high infusion
|
Dexmedetomidine loading dose 1.1 MCG/KG.Propofol infusion 200 MCG/KG/M
|
|
Active Comparator: V
Dexmedetomidine intermediate infusion, Propofol intermediate infusion
|
Dexmedetomidine loading dose 0.6 MCG/KG,Propofol infusion 200 MCG/KG/M
Dexmedetomidine loading dose 0.9 mcg/kg,Propofol infusion 140 mcg/kg/min
|
|
Active Comparator: III
Dexmedetomidine low infusion, Propofol high infusion
|
Dexmedetomidine loading dose 0.6 MCG/KG,Propofol infusion 200 MCG/KG/M
Dexmedetomidine loading dose 0.9 mcg/kg,Propofol infusion 140 mcg/kg/min
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Motor Evoked Potential Amplitude
Time Frame: baseline, 30 minutes
|
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.
|
baseline, 30 minutes
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- dexmedetomidine
- neuromonitoring
- spine procedures
- safe dose
- 1- safe dose of dexmedetomidine when used in total intravenous anesthesia for procedures require neuromonitoring
- 2- safe dose of propofol when uses in comination with dexmedetomidine in neuromontoring
- 3effect of dexmedetomidine on somatosensory evoked potential and motor evoked potentials
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Spinal Diseases
- Bone Diseases
- Spinal Curvatures
- Scoliosis
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Propofol
- Dexmedetomidine
Other Study ID Numbers
- 06-09-12
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