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

Sponsor:	Children's Hospital Medical Center, Cincinnati
Information provided by:	Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:	NCT00671931

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 I

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

Resource links provided by NLM:

MedlinePlus related topics: Scoliosis

Drug Information available for: Dexmedetomidine Dexmedetomidine hydrochloride Propofol

U.S. FDA Resources

Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:

the amplitude of (TcMEP) relative to baseline [ Time Frame: time of placement the first instrument in the spine ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

(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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671931

Contacts

Contact: mohamed mahmoud, MD	5136364408
Contact: EILEEN BECKMAN	5136364408

Locations

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

Sponsors and Collaborators

Children's Hospital Medical Center, Cincinnati

Investigators

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 February 09, 2012