Influence of Dexmedetomidine on the Evoked Potentials During Spine Surgery
NCT ID: NCT00494832
Last Updated: 2012-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2008-02-29
2010-05-31
Brief Summary
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1. To evaluate the safety and efficacy of Dexmedetomidine as an adjunct for anesthesia during spine surgery and
2. To investigate the influence of Dexmedetomidine on the evoked potentials.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dexmedetomidine
Dexmedetomidine infusion
Dexmedetomidine
10 minutes loading dose of 0.9 mcg/kg
Maintenance dose of 0.6 mcg/kg/hour
Placebo
Normal Saline infusion
Normal Saline
10 minutes loading dose of 0.9 mcg/kg
Maintenance dose of 0.6 mcg/kg/hour
Interventions
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Dexmedetomidine
10 minutes loading dose of 0.9 mcg/kg
Maintenance dose of 0.6 mcg/kg/hour
Normal Saline
10 minutes loading dose of 0.9 mcg/kg
Maintenance dose of 0.6 mcg/kg/hour
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with moderate neurological deficit
* ASA grade above 3
* Any chronic psychiatric disorder
* Body mass index (BMI) above 35
* Patients with cortical blindness, cataracts, retinal or optic neuropathy, glaucoma, untreated diabetes, active hepatitis, active coronary artery disease, untreated arrhythmias and patients with renal or hepatic insufficiency
18 Years
80 Years
ALL
No
Sponsors
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Hospira, now a wholly owned subsidiary of Pfizer
INDUSTRY
University of Washington
OTHER
Responsible Party
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Principal Investigators
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Irene Rozet, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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Harborview Medical Center
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Countries
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References
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Rozet I, Metzner J, Brown M, Treggiari MM, Slimp JC, Kinney G, Sharma D, Lee LA, Vavilala MS. Dexmedetomidine Does Not Affect Evoked Potentials During Spine Surgery. Anesth Analg. 2015 Aug;121(2):492-501. doi: 10.1213/ANE.0000000000000840.
Other Identifiers
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064705 A01
Identifier Type: OTHER
Identifier Source: secondary_id
31416-A
Identifier Type: -
Identifier Source: org_study_id