Susceptibility of Motor-Evoked Potentials to Varying Targeted Blood Levels of Dexmedetomidine
Information source: Children's Hospital Medical Center, Cincinnati
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Scoliosis
Intervention: low dexmedetomidine, low propofol (Drug); high dexmedetomidine, low propofol (Drug); Dexmedetomidine (Drug); Dexmedetomidin (Drug); Dexmedetomidine (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Children's Hospital Medical Center, Cincinnati Official(s) and/or principal investigator(s):
Mohamed Mahmoud, MD, Principal Investigator, Affiliation: Children's Hospital Medical Center, Cincinnati
Overall contact:
mohamed mahmoud, MD, Phone: 5136364408
Summary
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.
Clinical Details
Official title: Susceptibility of Motor-Evoked Potentials to Varying Targeted Blood Levels of Dexmedetomidine
Study design: Other, Randomized, Open Label, Dose Comparison, Factorial Assignment, Safety Study
Primary outcome: the amplitude of (TcMEP) relative to baseline
Secondary outcome: (a) Arterial blood pressure, heart rate and somatosensory evoked potentials amplitude (SSE
Eligibility
Minimum age: 10 Years.
Maximum age: 25 Years.
Gender(s): Both.
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)
Locations and Contacts
mohamed mahmoud, MD, Phone: 5136364408
Cincinati Children Medical Center, Cincinnati, Ohio 45229, United States; Recruiting
Mohamed Mahmoud, MD, Phone: 513-636-7337
Mohamed Mahmoud, MD, Principal Investigator
Cincinati Children Medical Center, cincinnati, Ohio 45229, United States; Recruiting
mohamed mahmoud, MD, Phone: 513-636-7337
mohamed mahmoud, MD, Principal Investigator
Additional Information
Starting date: April 2007
Last updated: May 2, 2008
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