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Influence of Dexmedetomidine on the Evoked Potentials During Spine Surgery
This study is currently recruiting participants.
Verified by University of Washington, October 2008
Sponsors and Collaborators: University of Washington
Hospira, Inc.
Information provided by: University of Washington
ClinicalTrials.gov Identifier: NCT00494832
  Purpose

The purposes of this study are:

  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.

Condition Intervention
Spine Surgery
Drug: Dexmedetomidine
Drug: Normal Saline

MedlinePlus related topics: Surgery
Drug Information available for: Dexmedetomidine Dexmedetomidine hydrochloride
U.S. FDA Resources
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

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Evoked potential amplitude less than 50% or latency less than 6 ms from baseline [ Time Frame: First 30 mins of surgery to the end of surgery ] [ Designated as safety issue: Yes ]

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
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


Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult spine surgery patients requiring evoked potentials monitoring.

Exclusion Criteria:

  • Age younger than 18 and older than 80 years
  • Patients with severe 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, diabetes, active coronary artery disease, and patients with renal or hepatic insufficiency
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00494832

Contacts
Contact: Irene Rozet, M.D. (206)-764-2117 irozet@u.washington.edu

Locations
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.            
Sponsors and Collaborators
University of Washington
Hospira, Inc.
Investigators
Principal Investigator: Irene Rozet, MD University of Washington
  More Information

No publications provided

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

Keywords provided by University of Washington:
Dexmedetomidine
Evoked potentials
Spine surgery

Study placed in the following topic categories:
Dexmedetomidine

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 12, 2009