<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/NCT04479566</url>
  </required_header>
  <id_info>
    <org_study_id>2020-27-2</org_study_id>
    <nct_id>NCT04479566</nct_id>
  </id_info>
  <brief_title>Effect of Lithium Carbonate on Postoperative Sleep in Patients Undergoing Videoassisted Thoracic Surgery</brief_title>
  <official_title>Effect of Lithium Carbonate on Postoperative Sleep in Patients Undergoing Videoassisted Thoracic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China Medical University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China Medical University, China</source>
  <oversight_info>
    <has_dmc>Yes</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>
      It has been proved that lithium carbonate can prolong slow wave sleep with few or no&#xD;
      side-effects. The aim of the present study is to evaluate postoperative sleep quality of&#xD;
      patients undergoing video assisted thoracic surgery taken 250mg lithium carbonate 6 hours&#xD;
      after surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a prospective, randomized, controlled (randomized, parallel group, concealed&#xD;
      allocation), double-blinded trial. All patients undergoing video assisted thoracic surgery&#xD;
      during morning will be randomized 1:1 to the treatment intervention with lithium carbonate&#xD;
      250mg (Baoqing, Hunan, China) or calcium carbonate 500mg (Reneed, Beijing, China) 6 hours&#xD;
      after surgery. The objective of the trial is to evaluate the lithium carbonate 250mg on the&#xD;
      first postoperative night sleep quality. The patients received standardized general&#xD;
      anesthesia supplemented by paravertebral nerve block. The ultrasound-guided approach for&#xD;
      paravertebral nerve block was used with the patient in the lateral decubitus position, and&#xD;
      the paravertebral nerve block was administered at the T4-T6 level according to the incision&#xD;
      protocol at our center. General anesthesia for maintenance of propofol anesthesia, total&#xD;
      intravenous anesthesia was administered by using propofol (Fresenius Kabi, Austria GmbH) at a&#xD;
      plasma target concentration (Marsh pharmacokinetic model software) of 2.5-4 μg/ml.&#xD;
      Remifentanil (0.2-0.5 μg/kg/min, Renfu, Yichang, China) was given to all patients during the&#xD;
      operation. All patients accepted patient-controlled intravenous analgesia with 1 μg ml-1&#xD;
      sufentanil (Renfu, Yichang, China). Duration of sleep was defined as the duration of all&#xD;
      bispectral index data below 80 in the 12 hours of monitoring (from 20:00pm to 06:00am).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 6, 2020</start_date>
  <completion_date type="Actual">January 31, 2022</completion_date>
  <primary_completion_date type="Actual">January 31, 2022</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>sleep quality</measure>
    <time_frame>first postoperative night</time_frame>
    <description>The primary objective is to compare postoperative sleep quality, as measured using a bispectral index-Vista monitor during the first night after surgery</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Sleep Deprivation</condition>
  <arm_group>
    <arm_group_label>lithium carbonate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergoing video assisted thoracic surgery during the morning will take 250mg lithium carbonate 6 hours after surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>calcium carbonate</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients undergoing video assisted thoracic surgery during the morning will take calcium carbonate 500mg 6 hours after surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lithium Carbonate 250 MG</intervention_name>
    <description>Patients undergoing video assisted thoracic surgery during the morning will take 250mg lithium carbonate 6 hours after surgery.</description>
    <arm_group_label>lithium carbonate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Calcium Carbonate 500 MG</intervention_name>
    <description>Patients undergoing video assisted thoracic surgery during the morning will take calcium carbonate 500mg 6 hours after surgery.</description>
    <arm_group_label>calcium carbonate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • 1. ethnic Chinese;&#xD;
&#xD;
          -  • 2. age, 18 to 75 years old;&#xD;
&#xD;
          -  • 3. American Society of Anaesthesiologists (ASA) physical status I or II;&#xD;
&#xD;
          -  • 4. required VATS for lung surgery and one lung ventilation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive difficulties&#xD;
&#xD;
          -  • Partial or complete gastrectomy&#xD;
&#xD;
          -  • Previous esophageal surgery&#xD;
&#xD;
          -  • Previous treated by radiotherapy or surgery&#xD;
&#xD;
          -  • Inability to conform to the study's requirements&#xD;
&#xD;
          -  • body mass index exceeding 30 kg/m2&#xD;
&#xD;
          -  • Deprivation of a right to decide by an administrative or juridical entity&#xD;
&#xD;
          -  • Ongoing participation or participation in another study &lt;1 month ago&#xD;
&#xD;
          -  • preoperative Pittsburgh Sleep Quality Index global scores higher than 6&#xD;
&#xD;
          -  • recent (&lt; 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics,&#xD;
             hormonal medication, laxatives, proton pump inhibitors, insulin sensitizers or&#xD;
             traditional Chinese medicine&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>male</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>the First Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>February 2, 2022</last_update_submitted>
  <last_update_submitted_qc>February 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>China Medical University, China</investigator_affiliation>
    <investigator_full_name>Wen-fei Tan</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>bispectral index</keyword>
  <keyword>lithium carbonate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Deprivation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lithium Carbonate</mesh_term>
    <mesh_term>Calcium Carbonate</mesh_term>
    <mesh_term>Calcium</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT04479566
org study id: 2020-27-2
nct id: NCT04479566
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
It has been proved that lithium carbonate can prolong slow wave sleep with few or no
      side-effects. The aim of the present study is to evaluate postoperative sleep quality of
      patients undergoing video assisted thoracic surgery taken 250mg lithium carbonate 6 hours
      after surgery.
This study is a prospective, randomized, controlled (randomized, parallel group, concealed
      allocation), double-blinded trial. All patients undergoing video assisted thoracic surgery
      during morning will be randomized 1:1 to the treatment intervention with lithium carbonate
      250mg (Baoqing, Hunan, China) or calcium carbonate 500mg (Reneed, Beijing, China) 6 hours
      after surgery. The objective of the trial is to evaluate the lithium carbonate 250mg on the
      first postoperative night sleep quality. The patients received standardized general
      anesthesia supplemented by paravertebral nerve block. The ultrasound-guided approach for
      paravertebral nerve block was used with the patient in the lateral decubitus position, and
      the paravertebral nerve block was administered at the T4-T6 level according to the incision
      protocol at our center. General anesthesia for maintenance of propofol anesthesia, total
      intravenous anesthesia was administered by using propofol (Fresenius Kabi, Austria GmbH) at a
      plasma target concentration (Marsh pharmacokinetic model software) of 2.5-4 μg/ml.
      Remifentanil (0.2-0.5 μg/kg/min, Renfu, Yichang, China) was given to all patients during the
      operation. All patients accepted patient-controlled intravenous analgesia with 1 μg ml-1
      sufentanil (Renfu, Yichang, China). Duration of sleep was defined as the duration of all
      bispectral index data below 80 in the 12 hours of monitoring (from 20:00pm to 06:00am).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: sleep quality
time frame: first postoperative night
description: The primary objective is to compare postoperative sleep quality, as measured using a bispectral index-Vista monitor during the first night after surgery
arm group label: lithium carbonate
arm group type: Experimental
description: Patients undergoing video assisted thoracic surgery during the morning will take 250mg lithium carbonate 6 hours after surgery.
arm group label: calcium carbonate
arm group type: Placebo Comparator
description: Patients undergoing video assisted thoracic surgery during the morning will take calcium carbonate 500mg 6 hours after surgery.
intervention type: Drug
intervention name: Lithium Carbonate 250 MG
description: Patients undergoing video assisted thoracic surgery during the morning will take 250mg lithium carbonate 6 hours after surgery.
arm group label: lithium carbonate
intervention type: Drug
intervention name: Calcium Carbonate 500 MG
description: Patients undergoing video assisted thoracic surgery during the morning will take calcium carbonate 500mg 6 hours after surgery.
arm group label: calcium carbonate
criteria: 
gender: Male
gender based: Yes
gender description: male
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: China Medical University, China
investigator full name: Wen-fei Tan
investigator title: Professor
mesh term: Sleep Deprivation
mesh term: Lithium Carbonate
mesh term: Calcium Carbonate
mesh term: Calcium
sharing ipd: Yes