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Sponsors and Collaborators: |
University of Washington Hospira, Inc. |
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Information provided by: | University of Washington |
ClinicalTrials.gov Identifier: | NCT00494832 |
The purposes of this study are:
Condition | Intervention |
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Spine Surgery |
Drug: Dexmedetomidine Drug: Normal Saline |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Influence of Dexmedetomidine on the Evoked Potentials During Spine Surgery |
Estimated Enrollment: | 200 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Dex: Placebo Comparator |
Drug: Dexmedetomidine
10 minutes loading dose of 1 mcg/kg Maintenance dose of 0.6 mcg/kg/hour |
Placebo: Active Comparator |
Drug: Normal Saline
10 minutes loading dose of 1 mcg/kg Maintenance dose of 0.6 mcg/kg/hour |
Use of evoked potentials can significantly improve neurologic outcome after major spine surgery. Modalities of evoked potentials commonly used are Somato-Sensory Evoked Potentials (SSEP's), Motor Evoked Potentials (MEP's), and Visual Evoked Potentials (VEP's).
Dexmedetomidine (DEX) is an alpha-2 agonist and has been FDA approved as an adjunct sedative agent to general anesthesia. It has been purported to reduce the amount of anesthetic required and potentiate the analgesic effect of opiates. In addition, DEX was shown to have minimal effect on SSEP's and VEP's in both rats and humans. Any decrease in the dose of general anesthesia that improves the monitoring of evoked potentials, supports DEX as an adjunct.
It is known that all anesthetic agents can interfere with the recording of evoked potentials. The choice of anesthetic however, depends on the modality of neurophysiologic monitoring planned for the patient. Total intravenous anesthesia (TIVA) and Sevoflurane, a low dose inhalational anesthetic are the usual agents for spine surgery. Both have a dose-related depressant effect on the quality of evoked potentials. As a result, it is common practice for the anesthesiologist to adjust the depth of anesthesia to improve signaling. The use of either anesthetic must accompany continuous infusion of Propofol and an opioid, Remifentanil or Fentanyl. The anesthesiologist then decides whether DEX should be as an adjunct. In our experience, DEX did not impair evoked potentials. In fact, it improved the quality of signals in a few patients. Yet, there are no published data of such effects in medical literature.
We hypothesize that Dexmedetomidine will not influence evoked potentials when used as an adjunct to general anesthesia. Our study is prospective, randomized, double-blinded and will be carried out on a set of anesthetics. We will first evaluate DEX as an adjunct in TIVA, then as an adjunct to Sevoflurane. The probable benefit of DEX may avoid the use of potent inhaled anesthetics which would improve VEP's monitoring. Quality recording of evoked potentials can enhance our ability to detect iatrogenic injury to the spinal cord and vision.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Irene Rozet, M.D. | (206)-764-2117 | irozet@u.washington.edu |
United States, Washington | |
Harborview Medical Center | Recruiting |
Seattle, Washington, United States, 98104 | |
Contact: Irene Rozet, MD 206-744-4371 irozet@u.washington.edu | |
Principal Investigator: Ramesh Ramaiah, MD | |
University of Washington Medical Center | Not yet recruiting |
Seattle, Washington, United States, 98114 | |
Contact: Iulia Metzner, M.D. 206-543-2670 metznj@u.washington.edu | |
Principal Investigator: Iulia Metzner, M.D. |
Principal Investigator: | Irene Rozet, MD | University of Washington |
Responsible Party: | University of Washington ( Irene Rozet, MD ) |
Study ID Numbers: | 06-4705 A 01 |
Study First Received: | June 28, 2007 |
Last Updated: | October 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00494832 |
Health Authority: | United States: Institutional Review Board |
Dexmedetomidine Evoked potentials Spine surgery |
Dexmedetomidine |
Neurotransmitter Agents Adrenergic alpha-Agonists Molecular Mechanisms of Pharmacological Action Adrenergic Agents Physiological Effects of Drugs Central Nervous System Depressants Pharmacologic Actions Adrenergic Agonists |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Hypnotics and Sedatives Analgesics Peripheral Nervous System Agents Central Nervous System Agents |