<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/NCT03793751</url>
  </required_header>
  <id_info>
    <org_study_id>201-26104-172-215441</org_study_id>
    <nct_id>NCT03793751</nct_id>
  </id_info>
  <brief_title>Effect of Intraoperative Dexmedetomidine on Early Postoperative Cognitive Dysfunction</brief_title>
  <official_title>Effect of Intraoperative Dexmedetomidine Infusion on Early Postoperative Cognitive Dysfunction (POCD) in Geriatric Patients Undergoing Hip Surgery Under Spinal Anaesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tata Main Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tata Main Hospital</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>
      This study will aim to identify the impact of Intraoperative dexmedetomidine infusion on POCD&#xD;
      assessed by the Montreal Cognitive Assessment (MoCA) in geriatric patients above 60 years&#xD;
      undergoing hip surgery under spinal anaesthesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperative cognitive dysfunction (POCD) is a common postoperative neurological&#xD;
      complication in elderly. POCD is a subtle impairment of memory, concentration and information&#xD;
      processing with clinical manifestations of delirium, anxiety, personality changes and&#xD;
      impaired memory, which is associated with prolonged hospitalization, a reduced quality of&#xD;
      life and an increase in morbidity and mortality. Dexmedetomidine is a highly selective α-2&#xD;
      adrenergic receptor agonist with a dose-dependent sedative hypnotic effect. It has also been&#xD;
      reported that dexmedetomidine has a potential role in preventing POCD due to its&#xD;
      neuroprotective effects both in vitro and in vivo.&#xD;
&#xD;
      Till date very few studies have analysed the impact of dexmedetomidine on early POCD. Even in&#xD;
      the few available studies compared assessment of POCD using the Mini-Mental State Examination&#xD;
      (MMSE) scores and found that MMSE have lower sensitivity for identifying Cognitive&#xD;
      Dysfunction as compared to Montreal Cognitive Assessment (MoCA). The study would analyze the&#xD;
      impact of Intraoperative Dexmedetomidine infusion on early Postoperative Cognitive&#xD;
      Dysfunction (POCD) in geriatric patients above 60 years undergoing hip surgery under spinal&#xD;
      anesthesia.&#xD;
&#xD;
      So this study will aim to identify the impact of Intraoperative dexmedetomidine infusion on&#xD;
      POCD assessed by the Montreal Cognitive Assessment (MoCA) in geriatric patients above 60&#xD;
      years undergoing hip surgery under spinal anaesthesia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">December 1, 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 2019</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>This will be a prospective, randomized, placebo-controlled, double-blind clinical trial. The patients will be recruited according to the inclusion criteria and will be distributed to one of the groups according to computer-generated random assignment. The personnel involved in the study, including statisticians, investigators, anaesthetists, surgeons and the patients will be blinded to the specific experimental scheme implementation Patients will be randomized into one of the two groups using a computer based random number generator. https://www.randomizer.org. All recordings would be performed by an anaesthesiologist blinded to the group allocation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Cases Developing POCD</measure>
    <time_frame>0-7 days</time_frame>
    <description>Number of cases developing POCD in the Dexmedetomidine Group as compared to the placebo group using the Montreal Cognitive Assessment (MoCA) test. The &quot;Montreal Cognitive Assessment&quot; (MoCA) test is a free assessment available at http://www.mocatest.org tool designed for quick screening for mild cognitive impairment. It is a one page, 30 point test done in approximately 10 min for assessment of attention, memory, abstraction, delayed recall and orientation, with total score of 30. MoCA range from zero to 30, with a score of 26 and higher generally considered normal. Scores below 26 were considered as Postoperative Cognitive Dysfunction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Systolic Blood Pressure</measure>
    <time_frame>Measured every 10 minutes upto 80 minutes, T0 as the initial reading.</time_frame>
    <description>Intraoperative Systolic Blood Pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic Blood Pressure</measure>
    <time_frame>Measured every 10 minutes upto 80 minutes, T0 as the initial reading.</time_frame>
    <description>Intraoperative Diastolic Blood Pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart Rate</measure>
    <time_frame>Measured every 10 minutes upto 80 minutes, T0 as the initial reading.</time_frame>
    <description>Intraoperative Heart Rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any Adverse Outcome</measure>
    <time_frame>0-7 days</time_frame>
    <description>Observation for any adverse effects</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Cognitive Dysfunction</condition>
  <arm_group>
    <arm_group_label>DEX Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receiving Dexmedetomidine injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CONTROL Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The Control Group will receive an equal volume placebo infusion of normal saline.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine Injection</intervention_name>
    <description>Dexmedetomidine Injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.</description>
    <arm_group_label>CONTROL Group</arm_group_label>
    <arm_group_label>DEX Group</arm_group_label>
    <other_name>Normal Saline as placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American society of Anesthesiology (ASA) status of I-III&#xD;
&#xD;
          -  Age between 60-75 years scheduled for elective hip surgery under spinal anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient not willing to be a part of the study&#xD;
&#xD;
          -  Patients were aged &lt;60 or &gt;75 years&#xD;
&#xD;
          -  Patients with accompanying medical conditions that may affect the level of&#xD;
             consciousness, such as stroke, stupor or dementia, or patients with abnormalities in&#xD;
             hepatic or renal function, electrolyte imbalance&#xD;
&#xD;
          -  Patients suffering from preoperative bradycardia [heart rate (HR) &lt;60 bpm] or&#xD;
             hypotension [mean arterial blood pressure (MAP) &lt;70 mmHg]&#xD;
&#xD;
          -  Patients who had recently received a sedative or opioid drug&#xD;
&#xD;
          -  Patients with a MoCA (Montreal Cognitive Assessment) score &lt;26&#xD;
&#xD;
          -  Patients with persistent hypotension and bradycardia intra-operatively even after&#xD;
             giving Mephentermine will be excluded from the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr.Deb S Nag, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tata Main Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dr.Deb Sanjay Nag</name>
      <address>
        <city>Jamshedpur</city>
        <state>Jharkhand</state>
        <zip>831011</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>December 30, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <results_first_submitted>December 31, 2019</results_first_submitted>
  <results_first_submitted_qc>March 10, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 24, 2020</results_first_posted>
  <last_update_submitted>April 6, 2020</last_update_submitted>
  <last_update_submitted_qc>April 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tata Main Hospital</investigator_affiliation>
    <investigator_full_name>Dr.Deb Sanjay Nag</investigator_full_name>
    <investigator_title>Consultant</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Cognitive Complications</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 1, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/51/NCT03793751/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>DEX Group</title>
          <description>Dexmedetomidine injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.</description>
        </group>
        <group group_id="P2">
          <title>CONTROL Group</title>
          <description>The Control Group will receive placebo infusion of normal saline.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
                <participants group_id="P2" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
                <participants group_id="P2" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Geriatric patients of American Society of Anaesthesiology (ASA) status of I-III between 60-75 years scheduled for elective hip surgery under spinal anaesthesia.</population>
      <group_list>
        <group group_id="B1">
          <title>DEX Group</title>
          <description>Dexmedetomidine injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.</description>
        </group>
        <group group_id="B2">
          <title>CONTROL Group</title>
          <description>The Control Group will receive placebo infusion of normal saline.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="60"/>
            <count group_id="B2" value="60"/>
            <count group_id="B3" value="120"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68.28" spread="3.93"/>
                    <measurement group_id="B2" value="68.48" spread="4.96"/>
                    <measurement group_id="B3" value="68.38" spread="4.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Indian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Cases Developing POCD</title>
        <description>Number of cases developing POCD in the Dexmedetomidine Group as compared to the placebo group using the Montreal Cognitive Assessment (MoCA) test. The &quot;Montreal Cognitive Assessment&quot; (MoCA) test is a free assessment available at http://www.mocatest.org tool designed for quick screening for mild cognitive impairment. It is a one page, 30 point test done in approximately 10 min for assessment of attention, memory, abstraction, delayed recall and orientation, with total score of 30. MoCA range from zero to 30, with a score of 26 and higher generally considered normal. Scores below 26 were considered as Postoperative Cognitive Dysfunction.</description>
        <time_frame>0-7 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DEX Group</title>
            <description>Dexmedetomidine injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.</description>
          </group>
          <group group_id="O2">
            <title>CONTROL Group</title>
            <description>The Control Group will receive placebo infusion of normal saline.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Cases Developing POCD</title>
          <description>Number of cases developing POCD in the Dexmedetomidine Group as compared to the placebo group using the Montreal Cognitive Assessment (MoCA) test. The &quot;Montreal Cognitive Assessment&quot; (MoCA) test is a free assessment available at http://www.mocatest.org tool designed for quick screening for mild cognitive impairment. It is a one page, 30 point test done in approximately 10 min for assessment of attention, memory, abstraction, delayed recall and orientation, with total score of 30. MoCA range from zero to 30, with a score of 26 and higher generally considered normal. Scores below 26 were considered as Postoperative Cognitive Dysfunction.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Systolic Blood Pressure</title>
        <description>Intraoperative Systolic Blood Pressure</description>
        <time_frame>Measured every 10 minutes upto 80 minutes, T0 as the initial reading.</time_frame>
        <population>Intraoperative Systolic Blood Pressure</population>
        <group_list>
          <group group_id="O1">
            <title>DEX Group</title>
            <description>Dexmedetomidine injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.</description>
          </group>
          <group group_id="O2">
            <title>CONTROL Group</title>
            <description>The Control Group will receive placebo infusion of normal saline.</description>
          </group>
        </group_list>
        <measure>
          <title>Systolic Blood Pressure</title>
          <description>Intraoperative Systolic Blood Pressure</description>
          <population>Intraoperative Systolic Blood Pressure</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>T0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="129.07" spread="13.5"/>
                    <measurement group_id="O2" value="125.4" spread="10.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="130.78" spread="19.46"/>
                    <measurement group_id="O2" value="125.45" spread="10.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="128.22" spread="13.78"/>
                    <measurement group_id="O2" value="127.48" spread="8.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="126.22" spread="13.91"/>
                    <measurement group_id="O2" value="123.03" spread="8.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="122.93" spread="13.47"/>
                    <measurement group_id="O2" value="119.1" spread="13.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117.71" spread="10.73"/>
                    <measurement group_id="O2" value="115.97" spread="11.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="115.88" spread="10.65"/>
                    <measurement group_id="O2" value="113.5" spread="10.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117.71" spread="10.96"/>
                    <measurement group_id="O2" value="131.33" spread="15.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="136.00" spread="5.29"/>
                    <measurement group_id="O2" value="155.00" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Diastolic Blood Pressure</title>
        <description>Intraoperative Diastolic Blood Pressure</description>
        <time_frame>Measured every 10 minutes upto 80 minutes, T0 as the initial reading.</time_frame>
        <population>Diastolic Blood Pressure</population>
        <group_list>
          <group group_id="O1">
            <title>DEX Group</title>
            <description>Dexmedetomidine injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.</description>
          </group>
          <group group_id="O2">
            <title>CONTROL Group</title>
            <description>The Control Group will receive placebo infusion of normal saline.</description>
          </group>
        </group_list>
        <measure>
          <title>Diastolic Blood Pressure</title>
          <description>Intraoperative Diastolic Blood Pressure</description>
          <population>Diastolic Blood Pressure</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>T0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.48" spread="9.38"/>
                    <measurement group_id="O2" value="80.40" spread="8.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.92" spread="9.06"/>
                    <measurement group_id="O2" value="78.15" spread="11.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.53" spread="7.61"/>
                    <measurement group_id="O2" value="80.17" spread="8.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.15" spread="9.34"/>
                    <measurement group_id="O2" value="77.02" spread="10.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.32" spread="8.44"/>
                    <measurement group_id="O2" value="72.77" spread="10.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.69" spread="7.78"/>
                    <measurement group_id="O2" value="70.43" spread="11.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.62" spread="7.35"/>
                    <measurement group_id="O2" value="68.38" spread="10.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.79" spread="6.97"/>
                    <measurement group_id="O2" value="78" spread="7.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.67" spread="5.51"/>
                    <measurement group_id="O2" value="90.00" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Heart Rate</title>
        <description>Intraoperative Heart Rate</description>
        <time_frame>Measured every 10 minutes upto 80 minutes, T0 as the initial reading.</time_frame>
        <population>Intraoperative heart rate</population>
        <group_list>
          <group group_id="O1">
            <title>DEX Group</title>
            <description>Dexmedetomidine injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.</description>
          </group>
          <group group_id="O2">
            <title>CONTROL Group</title>
            <description>The Control Group will receive placebo infusion of normal saline.</description>
          </group>
        </group_list>
        <measure>
          <title>Heart Rate</title>
          <description>Intraoperative Heart Rate</description>
          <population>Intraoperative heart rate</population>
          <units>Beats/minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>T0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.00" spread="11.21"/>
                    <measurement group_id="O2" value="81.90" spread="7.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.80" spread="11.37"/>
                    <measurement group_id="O2" value="82.02" spread="6.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.8" spread="11.37"/>
                    <measurement group_id="O2" value="82.02" spread="6.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.97" spread="11.27"/>
                    <measurement group_id="O2" value="82.65" spread="6.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.32" spread="11.08"/>
                    <measurement group_id="O2" value="83.20" spread="6.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.15" spread="10.57"/>
                    <measurement group_id="O2" value="84.00" spread="6.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.76" spread="10.59"/>
                    <measurement group_id="O2" value="85.35" spread="6.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.17" spread="10.46"/>
                    <measurement group_id="O2" value="86.67" spread="9.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.33" spread="9.71"/>
                    <measurement group_id="O2" value="95.00" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Any Adverse Outcome</title>
        <description>Observation for any adverse effects</description>
        <time_frame>0-7 days</time_frame>
        <population>Insidence of adverse outcomes</population>
        <group_list>
          <group group_id="O1">
            <title>DEX Group</title>
            <description>Dexmedetomidine injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.</description>
          </group>
          <group group_id="O2">
            <title>CONTROL Group</title>
            <description>The Control Group will receive placebo infusion of normal saline.</description>
          </group>
        </group_list>
        <measure>
          <title>Any Adverse Outcome</title>
          <description>Observation for any adverse effects</description>
          <population>Insidence of adverse outcomes</population>
          <units>number of cases</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During the hospital admission upto 7 days after day of surgery</time_frame>
      <desc>Common adverse effects of dexmedetomidine: Hypotension, hypertension, bradycardia, dry mouth and nausea. Other reported adverse effects include fever, rigors, cyanosis, muscle weakness. It may lead to arrhythmias, AV Block, cardiac arrest, T-wave inversion, tachycardia, angina pectoris, pulmonary edema, bronchospasm, respiratory depression, syncope, neuropathy, paresthesia, paresis, hyperkalaemia, lactic acidosis and hyperglycaemia.</desc>
      <group_list>
        <group group_id="E1">
          <title>DEX Group</title>
          <description>Dexmedetomidine injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.</description>
        </group>
        <group group_id="E2">
          <title>CONTROL Group</title>
          <description>The Control Group will receive placebo infusion of normal saline.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr.Deb Sanjay Nag</name_or_title>
      <organization>Tata Main Hospital, Tata Steel</organization>
      <phone>+91-9431166582</phone>
      <email>debsanjay@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03793751
org study id: 201-26104-172-215441
nct id: NCT03793751
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will aim to identify the impact of Intraoperative dexmedetomidine infusion on POCD
      assessed by the Montreal Cognitive Assessment (MoCA) in geriatric patients above 60 years
      undergoing hip surgery under spinal anaesthesia.
Postoperative cognitive dysfunction (POCD) is a common postoperative neurological
      complication in elderly. POCD is a subtle impairment of memory, concentration and information
      processing with clinical manifestations of delirium, anxiety, personality changes and
      impaired memory, which is associated with prolonged hospitalization, a reduced quality of
      life and an increase in morbidity and mortality. Dexmedetomidine is a highly selective α-2
      adrenergic receptor agonist with a dose-dependent sedative hypnotic effect. It has also been
      reported that dexmedetomidine has a potential role in preventing POCD due to its
      neuroprotective effects both in vitro and in vivo.

      Till date very few studies have analysed the impact of dexmedetomidine on early POCD. Even in
      the few available studies compared assessment of POCD using the Mini-Mental State Examination
      (MMSE) scores and found that MMSE have lower sensitivity for identifying Cognitive
      Dysfunction as compared to Montreal Cognitive Assessment (MoCA). The study would analyze the
      impact of Intraoperative Dexmedetomidine infusion on early Postoperative Cognitive
      Dysfunction (POCD) in geriatric patients above 60 years undergoing hip surgery under spinal
      anesthesia.

      So this study will aim to identify the impact of Intraoperative dexmedetomidine infusion on
      POCD assessed by the Montreal Cognitive Assessment (MoCA) in geriatric patients above 60
      years undergoing hip surgery under spinal anaesthesia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: This will be a prospective, randomized, placebo-controlled, double-blind clinical trial. The patients will be recruited according to the inclusion criteria and will be distributed to one of the groups according to computer-generated random assignment. The personnel involved in the study, including statisticians, investigators, anaesthetists, surgeons and the patients will be blinded to the specific experimental scheme implementation Patients will be randomized into one of the two groups using a computer based random number generator. https://www.randomizer.org. All recordings would be performed by an anaesthesiologist blinded to the group allocation.
measure: Number of Cases Developing POCD
time frame: 0-7 days
description: Number of cases developing POCD in the Dexmedetomidine Group as compared to the placebo group using the Montreal Cognitive Assessment (MoCA) test. The "Montreal Cognitive Assessment" (MoCA) test is a free assessment available at http://www.mocatest.org tool designed for quick screening for mild cognitive impairment. It is a one page, 30 point test done in approximately 10 min for assessment of attention, memory, abstraction, delayed recall and orientation, with total score of 30. MoCA range from zero to 30, with a score of 26 and higher generally considered normal. Scores below 26 were considered as Postoperative Cognitive Dysfunction.
measure: Systolic Blood Pressure
time frame: Measured every 10 minutes upto 80 minutes, T0 as the initial reading.
description: Intraoperative Systolic Blood Pressure
measure: Diastolic Blood Pressure
time frame: Measured every 10 minutes upto 80 minutes, T0 as the initial reading.
description: Intraoperative Diastolic Blood Pressure
measure: Heart Rate
time frame: Measured every 10 minutes upto 80 minutes, T0 as the initial reading.
description: Intraoperative Heart Rate
measure: Any Adverse Outcome
time frame: 0-7 days
description: Observation for any adverse effects
arm group label: DEX Group
arm group type: Experimental
description: Receiving Dexmedetomidine injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.
arm group label: CONTROL Group
arm group type: Placebo Comparator
description: The Control Group will receive an equal volume placebo infusion of normal saline.
intervention type: Drug
intervention name: Dexmedetomidine Injection
description: Dexmedetomidine Injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.
arm group label: CONTROL Group
arm group label: DEX Group
other name: Normal Saline as placebo
criteria: 
gender: All
minimum age: 60 Years
maximum age: 75 Years
healthy volunteers: No
last name: Dr.Deb S Nag, MD
role: Principal Investigator
affiliation: Tata Main Hospital
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Tata Main Hospital
investigator full name: Dr.Deb Sanjay Nag
investigator title: Consultant
mesh term: Postoperative Cognitive Complications
mesh term: Cognitive Dysfunction
mesh term: Dexmedetomidine
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 