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Trial record 1 of 1 for:    NCT00494832
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Influence of Dexmedetomidine on the Evoked Potentials During Spine Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00494832
Recruitment Status : Completed
First Posted : July 2, 2007
Last Update Posted : September 14, 2012
Sponsor:
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
University of Washington

Tracking Information
First Submitted Date  ICMJE June 28, 2007
First Posted Date  ICMJE July 2, 2007
Last Update Posted Date September 14, 2012
Study Start Date  ICMJE February 2008
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2009)
Change in evoked potentials [ Time Frame: Duration of surgery ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 28, 2007)
Effect of dexmedetomidine on evoked potentials during spine surgery. [ Time Frame: 2007-2009 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Influence of Dexmedetomidine on the Evoked Potentials During Spine Surgery
Official Title  ICMJE Influence of Dexmedetomidine on the Evoked Potentials During Spine Surgery
Brief Summary

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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Spine Surgery
Intervention  ICMJE
  • Drug: Dexmedetomidine

    10 minutes loading dose of 0.9 mcg/kg

    Maintenance dose of 0.6 mcg/kg/hour

    Other Name: Dexmedetomidine hydrochloride
  • Drug: Normal Saline

    10 minutes loading dose of 0.9 mcg/kg

    Maintenance dose of 0.6 mcg/kg/hour

    Other Name: 0.9% Sodium Chloride
Study Arms  ICMJE
  • Active Comparator: Dexmedetomidine
    Dexmedetomidine infusion
    Intervention: Drug: Dexmedetomidine
  • Placebo Comparator: Placebo
    Normal Saline infusion
    Intervention: Drug: Normal Saline
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 13, 2010)
40
Original Estimated Enrollment  ICMJE
 (submitted: June 28, 2007)
200
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult spine surgery patients requiring evoked potentials monitoring.

Exclusion Criteria:

  • Age younger than 18 and older than 80 years
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00494832
Other Study ID Numbers  ICMJE 31416-A
064705 A01 ( Other Identifier: University of Washington )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE Hospira, now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator: Irene Rozet, MD University of Washington
PRS Account University of Washington
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP