<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/NCT03025295</url>
  </required_header>
  <id_info>
    <org_study_id>XZ2015020</org_study_id>
    <nct_id>NCT03025295</nct_id>
  </id_info>
  <brief_title>The Effect of Orexin on Delayed Emergence of General Anesthesia in Dexmedetomidine</brief_title>
  <official_title>The Effect of Orexin on Delayed Emergence of General Anesthesia in Dexmedetomidine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>General Hospital of Ningxia Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>General Hospital of Ningxia Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current study is designed to investigate the difference of plasma orexin A levels between&#xD;
      Dexmedetomidine group and controlled group at emergence time from total intravenous&#xD;
      anesthesia who will undergo elective lumbar surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      DESIGNING: Fifty-one patients with ASA physical status I or II scheduled for elective surgery&#xD;
      under general anesthesia (lasting for 2h to 4h) were enrolled. Anesthesia was induced with&#xD;
      propofol 1-2mg/kg and sufentanyl 0.2-0.3μg/kg. Following muscle relaxation with iv&#xD;
      cisatracurium besylate 0.2mg/kg endotracheal intubation was performed. Anesthesia was&#xD;
      maintained with target controlled infusion propofol (targeted concentration:2-5ug/ml ) and&#xD;
      remifentanil (targeted concentration: 2-6ng/ml ). Muscle relaxation was maintained with&#xD;
      intermittent, but it do not injected in 1h before surgery completion. Propofol and&#xD;
      remifentanil were titrated to maintain the bispectral index (BIS) between 40 and 60 during&#xD;
      anesthesia. The end-tidal carbon dioxide level was maintained between 30 and 40 mmHg by&#xD;
      controlled mechanical ventilation. When the surgery was completed the investigators adjust&#xD;
      the targeted concentration of propofol 2ug/ml and targeted concentration of remifentanil to&#xD;
      2ng/ml then stop all anesthetics. Dexmedetomidine group target controlled infusion&#xD;
      dexmedetomidine (induction dose 1ug/kg with 10min, maintain dose 0.4ug/kg/h until 30min&#xD;
      before surgery completion). Control group infusion same saline. Record time from stopping&#xD;
      anesthetics to emergence and total doses of anesthetics. Arterial blood (2.5ml) was collected&#xD;
      at the following time, such as before and 1h after induction of anesthesia, at emergence (1&#xD;
      min after tracheal extubation) and half an hour after tracheal extubation. 2.0ml Arterial&#xD;
      blood was centrifuged at 3000 rpm for 15min at -4 ◦C in order to separate plasma then stored&#xD;
      at -80 ◦C until assay for orexin A concentrations. 0.5ml Arterial blood was measured blood&#xD;
      glucose.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">April 30, 2018</completion_date>
  <primary_completion_date type="Actual">April 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>orexin A concentrations</measure>
    <time_frame>2 year</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Dexmedetomidine group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Induction dose of dexmedetomidine is 1ug/kg with 10min, maintain dose is 0.4ug/kg/h until 30 min before surgery completion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Control group given equal volume of saline with the dexmedetomidine group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>Dexmedetomidine is common used to improve the prognosis and life quality of patients.</description>
    <arm_group_label>Dexmedetomidine group</arm_group_label>
    <other_name>Dexmedetomidine is a highly selective α2-adrenoceptor agonist.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>It is safe Placebo.</description>
    <arm_group_label>Saline group</arm_group_label>
    <other_name>It is safe Placebo.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Participant is Adult (≥18 years old and ≤60 years old)&#xD;
&#xD;
          2. Participants with a Body Mass Index (BMI) 20-25 kg/m2&#xD;
&#xD;
          3. Participants with ASA physical status Ⅰor Ⅱ&#xD;
&#xD;
          4. Participants with Heart function rating Ⅰor Ⅱ&#xD;
&#xD;
          5. Patients will undergo elective surgery and general anesthesia&#xD;
&#xD;
          6. The operation time is 2h to 4h.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participant is a pregnant woman or a nursing mother.&#xD;
&#xD;
          2. Participants have a history of narcotics allergic reactions.&#xD;
&#xD;
          3. Indices of liver or kidney function is twice higher than normal.&#xD;
&#xD;
          4. Participants have a history or diagnosis of depression.&#xD;
&#xD;
          5. Participants have a history of Brain Trauma.&#xD;
&#xD;
          6. Participants have a history of narcotics addiction or drug addiction.&#xD;
&#xD;
          7. Participants or his family have an International Classification of Sleep&#xD;
&#xD;
          8. Disorders diagnosis of obstructive sleep apnea syndrome.&#xD;
&#xD;
          9. Patients are refuse this trail or are not able to sign informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhihua Wang, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>General Hospital of Ningxia Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Anesthesiology department of General Hospital of Ningxia Medical University</name>
      <address>
        <city>Yinchuan</city>
        <state>Ningxia</state>
        <zip>750004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>June 18, 2021</last_update_submitted>
  <last_update_submitted_qc>June 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03025295
org study id: XZ2015020
nct id: NCT03025295
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The current study is designed to investigate the difference of plasma orexin A levels between
      Dexmedetomidine group and controlled group at emergence time from total intravenous
      anesthesia who will undergo elective lumbar surgery.
DESIGNING: Fifty-one patients with ASA physical status I or II scheduled for elective surgery
      under general anesthesia (lasting for 2h to 4h) were enrolled. Anesthesia was induced with
      propofol 1-2mg/kg and sufentanyl 0.2-0.3μg/kg. Following muscle relaxation with iv
      cisatracurium besylate 0.2mg/kg endotracheal intubation was performed. Anesthesia was
      maintained with target controlled infusion propofol (targeted concentration:2-5ug/ml ) and
      remifentanil (targeted concentration: 2-6ng/ml ). Muscle relaxation was maintained with
      intermittent, but it do not injected in 1h before surgery completion. Propofol and
      remifentanil were titrated to maintain the bispectral index (BIS) between 40 and 60 during
      anesthesia. The end-tidal carbon dioxide level was maintained between 30 and 40 mmHg by
      controlled mechanical ventilation. When the surgery was completed the investigators adjust
      the targeted concentration of propofol 2ug/ml and targeted concentration of remifentanil to
      2ng/ml then stop all anesthetics. Dexmedetomidine group target controlled infusion
      dexmedetomidine (induction dose 1ug/kg with 10min, maintain dose 0.4ug/kg/h until 30min
      before surgery completion). Control group infusion same saline. Record time from stopping
      anesthetics to emergence and total doses of anesthetics. Arterial blood (2.5ml) was collected
      at the following time, such as before and 1h after induction of anesthesia, at emergence (1
      min after tracheal extubation) and half an hour after tracheal extubation. 2.0ml Arterial
      blood was centrifuged at 3000 rpm for 15min at -4 ◦C in order to separate plasma then stored
      at -80 ◦C until assay for orexin A concentrations. 0.5ml Arterial blood was measured blood
      glucose.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: orexin A concentrations
time frame: 2 year
arm group label: Dexmedetomidine group
arm group type: Experimental
description: Induction dose of dexmedetomidine is 1ug/kg with 10min, maintain dose is 0.4ug/kg/h until 30 min before surgery completion.
arm group label: Saline group
arm group type: Placebo Comparator
description: Control group given equal volume of saline with the dexmedetomidine group.
intervention type: Drug
intervention name: Dexmedetomidine
description: Dexmedetomidine is common used to improve the prognosis and life quality of patients.
arm group label: Dexmedetomidine group
other name: Dexmedetomidine is a highly selective α2-adrenoceptor agonist.
intervention type: Drug
intervention name: Saline
description: It is safe Placebo.
arm group label: Saline group
other name: It is safe Placebo.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Zhihua Wang, M.D.
role: Study Chair
affiliation: General Hospital of Ningxia Medical University
facility: 
country: China
responsible party type: Sponsor
mesh term: Dexmedetomidine
sharing ipd: Undecided