<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/NCT02972762</url>
  </required_header>
  <id_info>
    <org_study_id>XiangyaH</org_study_id>
    <nct_id>NCT02972762</nct_id>
  </id_info>
  <brief_title>Anesthesia Depth's Influence on Postoperative Delirium</brief_title>
  <official_title>The Clinical Investigation of Anesthesia Depth's Influence in Total Intravenous Anesthesia on Postoperative Delirium of Elderly Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xiangya Hospital of Central South University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xiangya Hospital of Central South University</source>
  <brief_summary>
    <textblock>
      The investigators,according to the eligibility criteria,plane to choose 80 elderly&#xD;
      anticipates who will undergo selective hip replacement surgery.This participants will be&#xD;
      randomly divided into 2 groups:light anesthesia depth group(L Group) and deep anesthesia&#xD;
      depth group (D Group).Before anesthesia induction,each participant will be given lumbar&#xD;
      plexus and sciatic nerve block in order to control pain of interoperative and&#xD;
      postoperative.During operation period,the L Group will be kept in light anesthesia&#xD;
      depth(BIS:50-60),while the D group will be kept in deep anesthesia depth(BIS:35-45)--The BIS&#xD;
      values in the range of 30-60 have been recommended in general anesthesia.After operation,a&#xD;
      PCIA(patient controlled intravenous analgesia) analgesia pump will be given to each&#xD;
      participant to control postoperative pain. The investigator will evaluate the mental state of&#xD;
      participant with MMSE(mini-mental state examination) before surgery and review each&#xD;
      participant with a CAM-CR for 3 days after surgery to assess the situation of postoperation&#xD;
      delirium.intraoperative awareness,postoperative pain will also be investigated in&#xD;
      postoperative days 1, 2, 3.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators,according to the eligibility criteria,plane to choose 80 elderly&#xD;
      participants who will undergo selective hip replacement surgery.This participants will be&#xD;
      randomly divided into 2 groups:light anesthesia depth group(BIS:50-60) and deep anesthesia&#xD;
      depth group (BIS:35-45)--The BIS values in the range of 30-60 have been recommended in&#xD;
      general anesthesia.Before anesthesia induction,each participant will be given lumbar plexus&#xD;
      and sciatic nerve block in order to control pain of intraoperative and postoperative.The&#xD;
      investigator use propofol 4ug\kg、and sufentanil 0.2ug\kg during anesthesia induction&#xD;
      period,after that,a Laryngeal mask will be placed into patient's mouth.Anesthesia is&#xD;
      maintained with remifentanil TCI(target-controlled infusion) target-controlled&#xD;
      infusion(concentration:2ng/ml) and propofol BIS closed-loop target-controlled infusion.During&#xD;
      the operation period ,the investigator keep the L Group's BIS range from 50 to 60.While the D&#xD;
      Group's BIS range from 35 to 45.All participants receive postoperative analgesia.After&#xD;
      operation,all participants will be send to PACU(post-anaesthesia care unit ) to wake up and&#xD;
      send back to ward,And a PCIA(patient controlled intravenous analgesia) analgesia pump will be&#xD;
      given to each participants to control postoperative pain.The investigators will use&#xD;
      MMSE(mini-mental state examination) to evaluate the participant's mental state before&#xD;
      surgery.For 3 days after operation,The investigator will review each participant with a&#xD;
      CAM-CR to assess the situation of postoperation delirium.The investigator will see if there&#xD;
      is intraoperative awareness by asking questions.Postoperative pain(with VAS) will also be&#xD;
      investigated in postoperative days 1, 2, 3.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>Early Phase 1</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>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative delirium score(with The Confusion Assessment Method)</measure>
    <time_frame>3 days</time_frame>
    <description>the The Confusion Assessment Method is widely used to access the postoperative delirium all around the world.the total score more than 22 means that the The participant has got delirium.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>final data analysis</measure>
    <time_frame>10 days</time_frame>
    <description>the investigators use SPSS software to analysis data.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>postoperative pain score(with visual analogue scale)</measure>
    <time_frame>3 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>intraoperative awareness</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Femur Head Necrosis</condition>
  <arm_group>
    <arm_group_label>L Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The participants in L Group will receive Lumbar plexus and sciatic nerve block with ropivacaine before anesthesia induction.The investigator use Diprivan TCI target-controlled infusion during anesthesia induction period, target effect-site concentration is set at 4.0g / kg. After reaching the target concentration, sufentanil 0.2g / kg is administrated, Laryngeal mask will be placed into participant's mouth at 2 min after sufentanil is given. Anesthesia will be maintained with remifentanil TCI target-controlled infusion and Diprivan BIS close-loop target controlled infusion,BIS ranges from 50 to 60.The values of BP,P,PetCO2 will be controled in proper site. each participant will be given postoperative analgesia pump to release postoperative pain.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>D Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The participant in L Group will receive Lumbar plexus and sciatic nerve block with ropivacaine before anesthesia induction.The investigator use Diprivan TCI target-controlled infusion during anesthesia induction period, target effect-site concentration is set at 4.0g / kg. After reaching the target concentration, sufentanil 0.2g / kg is administrated, Laryngeal mask will be placed into participant's mouth at 2 min after sufentanil is given. Anesthesia will be maintained with remifentanil TCI target-controlled infusion and Diprivan BIS close-loop target controlled infusion,BIS ranges from 35 to 45.The values of BP,P,PetCO2 will be controled in proper site. The investigator use postoperative analgesia pump to control postoperative pain for each participant.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diprivan</intervention_name>
    <description>anesthesia will be maintained with remifentanil and Diprivan.we use Diprivan close-loop to control the anesthesia depth,and the anesthesia depth will be detected with BIS machine.the usage of remifentanil、ropivacaine、sufentanil and cisatracurium in both arms is no difference.</description>
    <arm_group_label>D Group</arm_group_label>
    <arm_group_label>L Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. participant who is selected to undergo hip replacement surgery.&#xD;
&#xD;
          2. participant who is older than 60 years old.&#xD;
&#xD;
          3. participant whose ASA（The American Society of Anesthesiologists） is II-III.&#xD;
&#xD;
          4. participant whose BMI is 18-25.&#xD;
&#xD;
          5. participant who is able to understand and complete The Confusion Assessment&#xD;
             Method(CAM-CR).&#xD;
&#xD;
          6. participant who is able to finish Visual Analogue Scale(VAS).&#xD;
&#xD;
          7. participant who is conscious and willing to take part in this research.&#xD;
&#xD;
          8. participant and his/her relatives are willing to take part in this research.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. participant who has serious liver or kidney disease.&#xD;
&#xD;
          2. participant who suffer from mental or neurologic disease,such as Alzheimer disease.&#xD;
&#xD;
          3. participant who has undergone cardiovascular surgery or neurosurgery.&#xD;
&#xD;
          4. participant who has have sedation or antidepression medicine for a long time.&#xD;
&#xD;
          5. participant who has something wrong with his/her vision or hearing.&#xD;
&#xD;
          6. participant who has blood coagulation dysfunction.&#xD;
&#xD;
          7. participant who is an illiteracy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>tao Zhong, doctor</last_name>
    <role>Study Director</role>
    <affiliation>Xiangya hospital of CSU</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Xiangya hospital of CSU</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>December 13, 2017</last_update_submitted>
  <last_update_submitted_qc>December 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>depth of anesthesia\postoperation delirium</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Femur Head Necrosis</mesh_term>
    <mesh_term>Delirium</mesh_term>
    <mesh_term>Emergence Delirium</mesh_term>
    <mesh_term>Necrosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propofol</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/NCT02972762
org study id: XiangyaH
nct id: NCT02972762
lead sponsor: 
The investigators,according to the eligibility criteria,plane to choose 80 elderly
      anticipates who will undergo selective hip replacement surgery.This participants will be
      randomly divided into 2 groups:light anesthesia depth group(L Group) and deep anesthesia
      depth group (D Group).Before anesthesia induction,each participant will be given lumbar
      plexus and sciatic nerve block in order to control pain of interoperative and
      postoperative.During operation period,the L Group will be kept in light anesthesia
      depth(BIS:50-60),while the D group will be kept in deep anesthesia depth(BIS:35-45)--The BIS
      values in the range of 30-60 have been recommended in general anesthesia.After operation,a
      PCIA(patient controlled intravenous analgesia) analgesia pump will be given to each
      participant to control postoperative pain. The investigator will evaluate the mental state of
      participant with MMSE(mini-mental state examination) before surgery and review each
      participant with a CAM-CR for 3 days after surgery to assess the situation of postoperation
      delirium.intraoperative awareness,postoperative pain will also be investigated in
      postoperative days 1, 2, 3.
The investigators,according to the eligibility criteria,plane to choose 80 elderly
      participants who will undergo selective hip replacement surgery.This participants will be
      randomly divided into 2 groups:light anesthesia depth group(BIS:50-60) and deep anesthesia
      depth group (BIS:35-45)--The BIS values in the range of 30-60 have been recommended in
      general anesthesia.Before anesthesia induction,each participant will be given lumbar plexus
      and sciatic nerve block in order to control pain of intraoperative and postoperative.The
      investigator use propofol 4ug\kg、and sufentanil 0.2ug\kg during anesthesia induction
      period,after that,a Laryngeal mask will be placed into patient's mouth.Anesthesia is
      maintained with remifentanil TCI(target-controlled infusion) target-controlled
      infusion(concentration:2ng/ml) and propofol BIS closed-loop target-controlled infusion.During
      the operation period ,the investigator keep the L Group's BIS range from 50 to 60.While the D
      Group's BIS range from 35 to 45.All participants receive postoperative analgesia.After
      operation,all participants will be send to PACU(post-anaesthesia care unit ) to wake up and
      send back to ward,And a PCIA(patient controlled intravenous analgesia) analgesia pump will be
      given to each participants to control postoperative pain.The investigators will use
      MMSE(mini-mental state examination) to evaluate the participant's mental state before
      surgery.For 3 days after operation,The investigator will review each participant with a
      CAM-CR to assess the situation of postoperation delirium.The investigator will see if there
      is intraoperative awareness by asking questions.Postoperative pain(with VAS) will also be
      investigated in postoperative days 1, 2, 3.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: postoperative delirium score(with The Confusion Assessment Method)
time frame: 3 days
description: the The Confusion Assessment Method is widely used to access the postoperative delirium all around the world.the total score more than 22 means that the The participant has got delirium.
measure: final data analysis
time frame: 10 days
description: the investigators use SPSS software to analysis data.
measure: postoperative pain score(with visual analogue scale)
time frame: 3 days
measure: intraoperative awareness
time frame: 1 day
arm group label: L Group
arm group type: Active Comparator
description: The participants in L Group will receive Lumbar plexus and sciatic nerve block with ropivacaine before anesthesia induction.The investigator use Diprivan TCI target-controlled infusion during anesthesia induction period, target effect-site concentration is set at 4.0g / kg. After reaching the target concentration, sufentanil 0.2g / kg is administrated, Laryngeal mask will be placed into participant's mouth at 2 min after sufentanil is given. Anesthesia will be maintained with remifentanil TCI target-controlled infusion and Diprivan BIS close-loop target controlled infusion,BIS ranges from 50 to 60.The values of BP,P,PetCO2 will be controled in proper site. each participant will be given postoperative analgesia pump to release postoperative pain.
arm group label: D Group
arm group type: Active Comparator
description: The participant in L Group will receive Lumbar plexus and sciatic nerve block with ropivacaine before anesthesia induction.The investigator use Diprivan TCI target-controlled infusion during anesthesia induction period, target effect-site concentration is set at 4.0g / kg. After reaching the target concentration, sufentanil 0.2g / kg is administrated, Laryngeal mask will be placed into participant's mouth at 2 min after sufentanil is given. Anesthesia will be maintained with remifentanil TCI target-controlled infusion and Diprivan BIS close-loop target controlled infusion,BIS ranges from 35 to 45.The values of BP,P,PetCO2 will be controled in proper site. The investigator use postoperative analgesia pump to control postoperative pain for each participant.
intervention type: Drug
intervention name: Diprivan
description: anesthesia will be maintained with remifentanil and Diprivan.we use Diprivan close-loop to control the anesthesia depth,and the anesthesia depth will be detected with BIS machine.the usage of remifentanil、ropivacaine、sufentanil and cisatracurium in both arms is no difference.
arm group label: D Group
arm group label: L Group
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: tao Zhong, doctor
role: Study Director
affiliation: Xiangya hospital of CSU
facility: 
country: China
responsible party type: Sponsor
mesh term: Femur Head Necrosis
mesh term: Delirium
mesh term: Emergence Delirium
mesh term: Necrosis
mesh term: Propofol