Susceptibility of Motor-Evoked Potentials to Varying Targeted Blood Levels of Dexmedetomidine
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Scoliosis |
Drug: low dexmedetomidine, low propofol Drug: high dexmedetomidine, low propofol Drug: Dexmedetomidine Drug: Dexmedetomidin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Factorial Assignment Masking: Open Label |
| Official Title: | Susceptibility of Motor-Evoked Potentials to Varying Targeted Blood Levels of Dexmedetomidine |
- the amplitude of (TcMEP) relative to baseline [ Time Frame: time of placement the first instrument in the spine ] [ Designated as safety issue: Yes ]
- (a) Arterial blood pressure, heart rate and somatosensory evoked potentials amplitude (SSE [ Time Frame: time of dexmedetomidine loading ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 73 |
| Study Start Date: | April 2007 |
| Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: I
Dexmedetomidine low infusion, Propofol low infusion
|
Drug: low dexmedetomidine, low propofol
Dexmedetomidine loading dose 0.6 MCG/KG,Propofol infusion 100 MCG/KG/M
|
|
Active Comparator: II
Dexmedetomidine high infusion, Propofol low infusion
|
Drug: high dexmedetomidine, low propofol
Dexmedetomidine loading dose 1.1 MCG/KG ,Propofol infusion 100 MCG/KG/M
|
|
Active Comparator: IV
Dexmedetomidine high infusion, Propofol high infusion
|
Drug: Dexmedetomidin
Dexmedetomidine loading dose 1.1 MCG/KG.Propofol infusion 200 MCG/KG/M
|
|
Active Comparator: V
Dexmedetomidine intermediate infusion, Propofol intermediate infusion
|
Drug: Dexmedetomidine
Dexmedetomidine loading dose 0.9 mcg/kg,Propofol infusion 140 mcg/kg/min
|
|
Active Comparator: III
Dexmedetomidine low infusion, Propofol high infusion
|
Drug: Dexmedetomidine
Dexmedetomidine loading dose 0.6 MCG/KG,Propofol infusion 200 MCG/KG/M
|
Eligibility| Ages Eligible for Study: | 10 Years to 25 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| Contact: mohamed mahmoud, MD | 5136364408 | |
| Contact: EILEEN BECKMAN | 5136364408 |
| United States, Ohio | |
| Cincinati Children Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45229 | |
| Contact: Mohamed Mahmoud, MD 513-636-7337 | |
| Principal Investigator: Mohamed Mahmoud, MD | |
| Cincinati Children Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45229 | |
| Contact: mohamed mahmoud, MD 513-636-7337 | |
| Principal Investigator: mohamed mahmoud, MD | |
| Principal Investigator: | Mohamed Mahmoud, MD | Children's Hospital Medical Center, Cincinnati |
More Information
No publications provided
| Responsible Party: | Mohamed Mahmoud, MD, Cincinnati Children's Hospital Medical Center |
| ClinicalTrials.gov Identifier: | NCT00671931 History of Changes |
| Other Study ID Numbers: | 06-09-12 |
| Study First Received: | April 30, 2008 |
| Last Updated: | May 2, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Children's Hospital Medical Center, Cincinnati:
|
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:
|
Disease Susceptibility Genetic Predisposition to Disease Scoliosis Disease Attributes Pathologic Processes Spinal Curvatures Spinal Diseases Bone Diseases Musculoskeletal Diseases Propofol Dexmedetomidine Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Hypnotics and Sedatives Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013