<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/NCT03010098</url>
  </required_header>
  <id_info>
    <org_study_id>double closed-loop and POCD</org_study_id>
    <nct_id>NCT03010098</nct_id>
  </id_info>
  <brief_title>The Effect on the Older's Cognition of Dual-loop Target Controlled Infusion Guided by Narcotrend Index</brief_title>
  <acronym>POCD;TCI</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Guangzhou General Hospital of Guangzhou Military Command</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangzhou General Hospital of Guangzhou Military Command</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the effect on older's cognition of the application of closed target-controlled&#xD;
      infusion(TCI) of propofol and remifentanil guided by Narcotrend index .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Two hundreds of patients scheduled for surgery under general anesthesia were randomly divided&#xD;
      into two groups:closed-loop (group A,n=100) and open-loop group(group B,n=100).The procedure&#xD;
      during induction of anesthesia was same in two groups.In group A,if Narcotrend index(NI) fall&#xD;
      down to 46 and keep more than 30 seconds,propofol and remifentanil were intravenously infused&#xD;
      as feedback automatically to achieve the target NI of 26-46.However,the NI in group B was&#xD;
      controlled manually.Taking an exam of MMSE before and after the surgery which measures if the&#xD;
      older's cognition changed. Furthermore.we will measure the levels of protein S100beta and&#xD;
      NSE.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">July 2017</completion_date>
  <primary_completion_date type="Anticipated">June 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>MMSE scores</measure>
    <time_frame>up to 1 week</time_frame>
    <description>The Mini-Mental State Examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment.It is commonly used in medicine and allied health to screen for dementia. It is also used to estimate the severity and progression of cognitive impairment and to follow the course of cognitive changes in an individual over time; thus making it an effective way to document an individual's response to treatment. The MMSE's purpose has been not, on its own, to provide a diagnosis for any particular nosological entity.We measure the patient before the operation and the first/third/seventh day after the operation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>protein s100beta</measure>
    <time_frame>up to 24 hours</time_frame>
    <description>The calcium-binding protein S100b is enriched in astroglial cells and can cross the blood-brain barrier after hypoxic damage of the central nervous system. Its routine measurement is simple and relatively inexpensive. S100b is filtrated by the kidney and has an estimated half-life of 2 h . Its serum level increases after CA, and its prognostic value has been studied . Because of mitigated results, its routine use has been, up to now, not recommended. S100bata is normally 0.2μg/L in serum or more smaller.We decide to take the blood sample before the operation and after the operation when the patient is awake.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>NSE</measure>
    <time_frame>up to 24 hours</time_frame>
    <description>NSE has a role in glucose metabolism. As for S100b, NSE is released from the hypoxic brain into the bloodstream, and its serum level correlates with the extent of brain injury. Also, NSE correlates with other markers of brain injury . NSE has a high specificity to predict adverse outcomes when measured in the few days post CA. A cutoff point of 33 mg/l is recommended.in our study, we take the blood sample before the operation and after the operation when the patient awake.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Dual-Loop TCI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the investigator modified the effect-site target concentrations by NI.If NI fall down to 46 and keep 46 more than 30 seconds,propofol and remifentanil were infused as feedback automatically to achieve the target NI of 26-46.Take blood sample before and after surgery to measure the levels of protein S100beta and NSE.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Open-Loop TCI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the investigator modified the effect-site target concentrations of both drugs without minimum or maximum concentration limits without using the Narcotrend monitor only depend on the experience of anesthesiologist.Take blood sample before and after surgery to measure the levels of protein S100beta and NSE.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dual-Loop TCI</intervention_name>
    <description>the investigator modified the effect-site target concentrations by NI.If NI fall down to 46 and keep 46 more than 30 seconds,propofol and remifentanil were infused as feedback automatically to achieve the target NI of 26-46</description>
    <arm_group_label>Dual-Loop TCI</arm_group_label>
    <other_name>Dual-Loop Target Controlled Infusion of Propofol and Remifentanil Guided by Narcotrend Inde</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Open-Loop TCI</intervention_name>
    <description>the investigator modified the effect-site target concentrations of both drugs without minimum or maximum concentration limits without using the Narcotrend monitor only depend on the experience of anesthesiologist.</description>
    <arm_group_label>Open-Loop TCI</arm_group_label>
    <other_name>Control infusion of propofol and remifentanil guided by experience</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ASA Ⅰ ~ Ⅱ women undergoing Laparoscopic surgery.&#xD;
&#xD;
          2. Written informed consent from the patient or the relatives of the participating&#xD;
             patient.&#xD;
&#xD;
          3. BMI:18.0～25 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Mental illness can not match&#xD;
&#xD;
          2. epidural anesthesia contraindicated&#xD;
&#xD;
          3. People who have Slow-type arrhythmias&#xD;
&#xD;
          4. Chronic renal failure&#xD;
&#xD;
          5. Alcohol or drug abuse&#xD;
&#xD;
          6. Already taking gabapentin, pregabalin, benzodiazepin or antidepression dru&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Guangzhou Military Region General Hospital, Department of Anesthesiology</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510010</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>bo xu</last_name>
      <phone>88653387</phone>
      <phone_ext>020</phone_ext>
      <email>xubo333@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>li ma</last_name>
      <phone>13602445723</phone>
      <email>603706566@qq.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>January 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>January 2, 2017</last_update_submitted>
  <last_update_submitted_qc>January 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangzhou General Hospital of Guangzhou Military Command</investigator_affiliation>
    <investigator_full_name>bo xu</investigator_full_name>
    <investigator_title>associate chief physician</investigator_title>
  </responsible_party>
  <keyword>POCD</keyword>
  <keyword>narcotrend</keyword>
  <keyword>closed-loop of target controlled infusion</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Remifentanil</mesh_term>
    <mesh_term>Propofol</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/NCT03010098
org study id: double closed-loop and POCD
nct id: NCT03010098
lead sponsor: 
has dmc: No
To investigate the effect on older's cognition of the application of closed target-controlled
      infusion(TCI) of propofol and remifentanil guided by Narcotrend index .
Two hundreds of patients scheduled for surgery under general anesthesia were randomly divided
      into two groups:closed-loop (group A,n=100) and open-loop group(group B,n=100).The procedure
      during induction of anesthesia was same in two groups.In group A,if Narcotrend index(NI) fall
      down to 46 and keep more than 30 seconds,propofol and remifentanil were intravenously infused
      as feedback automatically to achieve the target NI of 26-46.However,the NI in group B was
      controlled manually.Taking an exam of MMSE before and after the surgery which measures if the
      older's cognition changed. Furthermore.we will measure the levels of protein S100beta and
      NSE.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: MMSE scores
time frame: up to 1 week
description: The Mini-Mental State Examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment.It is commonly used in medicine and allied health to screen for dementia. It is also used to estimate the severity and progression of cognitive impairment and to follow the course of cognitive changes in an individual over time; thus making it an effective way to document an individual's response to treatment. The MMSE's purpose has been not, on its own, to provide a diagnosis for any particular nosological entity.We measure the patient before the operation and the first/third/seventh day after the operation.
measure: protein s100beta
time frame: up to 24 hours
description: The calcium-binding protein S100b is enriched in astroglial cells and can cross the blood-brain barrier after hypoxic damage of the central nervous system. Its routine measurement is simple and relatively inexpensive. S100b is filtrated by the kidney and has an estimated half-life of 2 h . Its serum level increases after CA, and its prognostic value has been studied . Because of mitigated results, its routine use has been, up to now, not recommended. S100bata is normally 0.2μg/L in serum or more smaller.We decide to take the blood sample before the operation and after the operation when the patient is awake.
measure: NSE
time frame: up to 24 hours
description: NSE has a role in glucose metabolism. As for S100b, NSE is released from the hypoxic brain into the bloodstream, and its serum level correlates with the extent of brain injury. Also, NSE correlates with other markers of brain injury . NSE has a high specificity to predict adverse outcomes when measured in the few days post CA. A cutoff point of 33 mg/l is recommended.in our study, we take the blood sample before the operation and after the operation when the patient awake.
arm group label: Dual-Loop TCI
arm group type: Experimental
description: the investigator modified the effect-site target concentrations by NI.If NI fall down to 46 and keep 46 more than 30 seconds,propofol and remifentanil were infused as feedback automatically to achieve the target NI of 26-46.Take blood sample before and after surgery to measure the levels of protein S100beta and NSE.
arm group label: Open-Loop TCI
arm group type: Experimental
description: the investigator modified the effect-site target concentrations of both drugs without minimum or maximum concentration limits without using the Narcotrend monitor only depend on the experience of anesthesiologist.Take blood sample before and after surgery to measure the levels of protein S100beta and NSE.
intervention type: Device
intervention name: Dual-Loop TCI
description: the investigator modified the effect-site target concentrations by NI.If NI fall down to 46 and keep 46 more than 30 seconds,propofol and remifentanil were infused as feedback automatically to achieve the target NI of 26-46
arm group label: Dual-Loop TCI
other name: Dual-Loop Target Controlled Infusion of Propofol and Remifentanil Guided by Narcotrend Inde
intervention type: Device
intervention name: Open-Loop TCI
description: the investigator modified the effect-site target concentrations of both drugs without minimum or maximum concentration limits without using the Narcotrend monitor only depend on the experience of anesthesiologist.
arm group label: Open-Loop TCI
other name: Control infusion of propofol and remifentanil guided by experience
criteria: 
gender: All
minimum age: 60 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Guangzhou General Hospital of Guangzhou Military Command
investigator full name: bo xu
investigator title: associate chief physician
mesh term: Remifentanil
mesh term: Propofol
sharing ipd: Undecided