<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03236727</url>
  </required_header>
  <id_info>
    <org_study_id>GeorgePHT</org_study_id>
    <nct_id>NCT03236727</nct_id>
  </id_info>
  <brief_title>SSEP Fluctuations Due to Dexmedetomidine During Posterior Spine Fusion</brief_title>
  <official_title>SSEP Fluctuations Due to Dexmedetomidine During Posterior Spine Fusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>George Papanicolaou Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>George Papanicolaou Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Intravenous anesthetic agents as far as inhaled agents produce a dose depended increase in&#xD;
      latency and decrease in amplitude of SomatoSensory Evoked Potential (SSEP). Dexmetedomidine,&#xD;
      a highly selective a2 adrenergic agonist, not only minimizes the anesthetic agents but also&#xD;
      the opioids, reducing the analgesic demands. The effect of dexmedetomidine on SSEP has not&#xD;
      been elucidated. We aimed to investigate alterations on somatosensory SSEP in adults during&#xD;
      posterior spinal fusion surgery before and after Dexmedetomidine administration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients 18-75 years old, ASA (physical status classification system) I-III, scheduled for&#xD;
      elective posterior spinal fusion surgery were enrolled in this prospective study. After&#xD;
      induction in anesthesia, it was applied SSEP monitoring and a baseline test was performed&#xD;
      after 15min (in order to wash out the propofol used for induction). Infusion of&#xD;
      Dexmedetomidine was started at a bolus dose of 1mcg/Kg following by 0.7mcg/Kg. Bispectral&#xD;
      Index (BIS) monitored the depth of anesthesia and an adequate level (40-50) of anesthesia was&#xD;
      maintained by sevoflurane. SSEP were recorded intraoperatively from the tibial nerve (P37)&#xD;
      and data were analyzed over that period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>SSEPs</measure>
    <time_frame>10 min after starting infusion of dexmedetomidine</time_frame>
    <description>measurement of SSEPs parameters regarding the baseline.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Spinal Fusion</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Data of SSEPs (amplitude and latency) before dexmedetomidine infusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dexmedetomidine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Data of SSEPs (amplitude and latency) after dexmedetomidine infusion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>Changes of both amplitude and latency of SSEPs during dexmedetomidine infusion.</description>
    <arm_group_label>Dexmedetomidine</arm_group_label>
    <other_name>Control-no dexmedetomidine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with ASA physical status 1-3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with ASA physical status &gt;3,&#xD;
&#xD;
          -  Body Mass Index (BMI) over 30,&#xD;
&#xD;
          -  indication for rapid sequence induction,&#xD;
&#xD;
          -  any contraindication for receiving b-blocker,&#xD;
&#xD;
          -  Glasgow Coma Scale (GCS) &lt;13,&#xD;
&#xD;
          -  history of drug abuse,&#xD;
&#xD;
          -  neurologic deficit or preoperatively foreseen delayed extubation,&#xD;
&#xD;
          -  preoperative heart rate&lt;45.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>August 1, 2017</last_update_submitted>
  <last_update_submitted_qc>August 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>George Papanicolaou Hospital</investigator_affiliation>
    <investigator_full_name>Asouhidou Irene</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Dexmedetomidine, spinal fusion, SSEP</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03236727
org study id: GeorgePHT
nct id: NCT03236727
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
Intravenous anesthetic agents as far as inhaled agents produce a dose depended increase in
      latency and decrease in amplitude of SomatoSensory Evoked Potential (SSEP). Dexmetedomidine,
      a highly selective a2 adrenergic agonist, not only minimizes the anesthetic agents but also
      the opioids, reducing the analgesic demands. The effect of dexmedetomidine on SSEP has not
      been elucidated. We aimed to investigate alterations on somatosensory SSEP in adults during
      posterior spinal fusion surgery before and after Dexmedetomidine administration.
Patients 18-75 years old, ASA (physical status classification system) I-III, scheduled for
      elective posterior spinal fusion surgery were enrolled in this prospective study. After
      induction in anesthesia, it was applied SSEP monitoring and a baseline test was performed
      after 15min (in order to wash out the propofol used for induction). Infusion of
      Dexmedetomidine was started at a bolus dose of 1mcg/Kg following by 0.7mcg/Kg. Bispectral
      Index (BIS) monitored the depth of anesthesia and an adequate level (40-50) of anesthesia was
      maintained by sevoflurane. SSEP were recorded intraoperatively from the tibial nerve (P37)
      and data were analyzed over that period.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: SSEPs
time frame: 10 min after starting infusion of dexmedetomidine
description: measurement of SSEPs parameters regarding the baseline.
arm group label: Control
arm group type: No Intervention
description: Data of SSEPs (amplitude and latency) before dexmedetomidine infusion.
arm group label: Dexmedetomidine
arm group type: Active Comparator
description: Data of SSEPs (amplitude and latency) after dexmedetomidine infusion.
intervention type: Drug
intervention name: Dexmedetomidine
description: Changes of both amplitude and latency of SSEPs during dexmedetomidine infusion.
arm group label: Dexmedetomidine
other name: Control-no dexmedetomidine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: George Papanicolaou Hospital
investigator full name: Asouhidou Irene
investigator title: Assistant Professor
mesh term: Dexmedetomidine