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The Effects of Dexmedetomidine Dose on Motor Evoked Potentials

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: NCT03378973
Recruitment Status : Terminated (No longer clinically relevant)
First Posted : December 20, 2017
Results First Posted : February 26, 2020
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Brief Summary:
This a parallel group, two-arm, randomized superiority trial that will compare the effect of two different doses of dexmedetomidine on motor evoked potentials during spine surgery

Condition or disease Intervention/treatment Phase
Spinal Fusion Drug: Dexmedetomidine Phase 4

Detailed Description:
This a parallel group, two-arm, randomized superiority trial that will compare the effect of two different doses of dexmedetomidine on suitability of motor evoked potentials for intraoperative monitoring during spine surgery

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: The anesthesiologist administering anesthetic agents will have knowledge of their doses. The technologist performing motor evoked potential testing and other participants will not.
Primary Purpose: Other
Official Title: The Effects of Dexmedetomidine Dose on Motor Evoked Potentials During Spine Surgery: A Randomized, Single-blind Trial
Actual Study Start Date : November 28, 2018
Actual Primary Completion Date : October 17, 2019
Actual Study Completion Date : October 17, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High dose dexmedetomidine
Patients will receive dexmedetomidine 0.5 mcg/kg/hr plus propofol 50 mcg/kg/min
Drug: Dexmedetomidine
Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery.
Other Name: Precedex

Active Comparator: Low dose dexmedetomidine
Patients will receive dexmedetomidine 1.0 mcg/kg/hr plus propofol 25 mcg/kg/min
Drug: Dexmedetomidine
Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery.
Other Name: Precedex




Primary Outcome Measures :
  1. Percent of Patients With Monitorable of Motor Evoked Potentials [ Time Frame: During a single surgery for the duration of the operation ]
    Monitorable is defined as stable signals being present in 3 muscles in each lower extremity, with mean peak-to-peak amplitude of at least 50 uV, and with mean-normalized interquartile variability of 0.9 or less.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing multi-level posterior spine fusions requiring motor evoked potential monitoring

Exclusion Criteria:

  • Allergy to dexmedetomidine, propofol
  • Conditions knows to make recording of motor evoked potentials difficult, including poorly controlled diabetes, severe peripheral neuropathy, severe myelopathy, or previous surgery during which motor evoked potentials were difficult to obtain
  • Hepatic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03378973


Locations
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United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
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Principal Investigator: Ronald Emerson, MD Hospital for Special Surgery, New York
  Study Documents (Full-Text)

Documents provided by Hospital for Special Surgery, New York:
Informed Consent Form  [PDF] November 28, 2017

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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT03378973    
Other Study ID Numbers: 2017-1304
First Posted: December 20, 2017    Key Record Dates
Results First Posted: February 26, 2020
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Hospital for Special Surgery, New York:
motor evoked potentials
Additional relevant MeSH terms:
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Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action