xml: <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/NCT06030804</url>
    </required_header>
    <id_info>
      <org_study_id>2023-227</org_study_id>
      <nct_id>NCT06030804</nct_id>
    </id_info>
    <brief_title>Perioperative Dexmedetomidine and Long-term Survival After Cancer Surgery</brief_title>
    <official_title>Impact of Perioperative Dexmedetomidine on Long-term Survival in Older Patients After Cancer Surgery: a Multicenter Randomized Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking University First Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Peking University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Peking University First 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>
        Along with aging population, cancer incidence and mortality are increasing. However, despite&#xD;
        advances in oncology and surgery, long-term survival of cancer patients is far from optimal.&#xD;
        Dexmedetomidine is a highly selective alpha 2 adrenergic receptor agonist with sedative,&#xD;
        analgesic, and anxiolytic effects. Studies showed that perioperative use of dexmedetomidine&#xD;
        reduces delirium and some non-delirium complications after surgery. In long-term follow-up&#xD;
        studies of older patients who, for other reasons, were randomized to receive either&#xD;
        dexmedetomidine or placebo during intra- or postoperative period, dexmedetomidine use was&#xD;
        associated with improved long-term survival. This multicenter randomized trial aims to&#xD;
        investigate the effect of perioperative dexmedetomidine on long-term outcomes in older&#xD;
        patients undergoing cancer surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Along with aging population, cancer incidence and mortality are increasing. Surgical&#xD;
        resection remains the mainstay treatment for solid organ cancer. However, despite advances in&#xD;
        oncology and surgery, long-term survival of cancer patients is far from optimal. For example,&#xD;
        the 5-year survival rate of cancer patients is about 36.9% in China, and the survival rate&#xD;
        decreases for about 10% each year in older patients after cancer surgery. How to improve&#xD;
        long-term survival after cancer surgery remains an urgent problem to be solved.&#xD;
  &#xD;
        Cancer death usually occur after cancer recurrence or metastasis. The development of cancer&#xD;
        recurrence or metastasise after surgical resection depends on the balance between the&#xD;
        anti-cancer defense function of host and the invasiveness of residual cancer cells. Studies&#xD;
        showed that surgery, while resecting cancer mass, also releases cancer cells into the&#xD;
        circulation. Surgical stress also impairs cell-mediated immunity and promote cancer growth.&#xD;
  &#xD;
        Dexmedetomidine is a highly selective alpha 2 adrenergic receptor agonist with sedative,&#xD;
        analgesic, and anxiolytic effects. Studies showed that intraoperative use of dexmedetomidine&#xD;
        reduces anesthetic and opioid consumption and relieves surgery-related stress response and&#xD;
        inflammation. Studies also showed that perioperative use of dexmedetomidine reduces delirium,&#xD;
        a commonly occurred complication in older patients, and some non-delirium complications after&#xD;
        surgery.&#xD;
  &#xD;
        The effect of perioperative dexmedetomidine on long-term outcomes after cancer surgery&#xD;
        remains unclear. In a long-term follow-up of older patients who were randomized to receive&#xD;
        either low-dose dexmedetomidine or placebo during intensive care unit stay, dexmedetomidine&#xD;
        use was associated with improved survival within 2 years. In a recent long-term follow-up of&#xD;
        older patients who were randomized to receive either dexmedetomidine or placebo during&#xD;
        surgery, dexmedetomidine use was associated with improved recurrence-free survival.&#xD;
  &#xD;
        The investigators hypothesize that perioperative use of dexmedetomidine may improve long-term&#xD;
        survival after cancer surgery. This multicenter randomized trial aims to investigate the&#xD;
        effect of perioperative dexmedetomidine on long-term outcomes in older patients undergoing&#xD;
        cancer surgery.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 12, 2023</start_date>
    <completion_date type="Anticipated">October 2028</completion_date>
    <primary_completion_date type="Anticipated">September 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Overall survival after surgery</measure>
      <time_frame>Up to 3 years after surgery of the last enrolled patient.</time_frame>
      <description>Time interval from index surgery to all-cause death.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival after surgery</measure>
      <time_frame>Up to 3 years after surgery of the last enrolled patient.</time_frame>
      <description>Time interval from index surgery to cancer recurrence/metastasis/progression or all-cause death, whichever comes first.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Event-free survival after surgery</measure>
      <time_frame>Up to 3 years after surgery of the last enrolled patient.</time_frame>
      <description>Time interval from index surgery to cancer recurrence/metastasis/progression, new-onset cancer, new-onset serious illness (requiring hospitalization), or all-cause death, whichever comes first.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cancer-specific survival after surgery</measure>
      <time_frame>Up to 3 years after surgery of the last enrolled patient.</time_frame>
      <description>Time interval from index surgery to cancer-specific death, with deaths from other causes being censored at the time of death. Cancer-specific death is defined as death fully attributable to the cancer for which the index surgery is performed and usually involves cancer recurrence/metastasis/progression after exclusion of other causes such as stroke and myocardial infarction.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Rate of intensive care unit (ICU) admission after surgery.</measure>
      <time_frame>Up to 30 days after surgery.</time_frame>
      <description>Percentage of patients who required ICU admission within 30 days after surgery.</description>
    </other_outcome>
    <other_outcome>
      <measure>Incidence of postoperative delirium.</measure>
      <time_frame>During the first 4 postoperative days.</time_frame>
      <description>Delirium will be assessed with the 3D-Confusion Assessment Method (3D-CAM) or CAM for the Intensive Care Unit (CAM-ICU) twice daily during the first 4 postoperative days.</description>
    </other_outcome>
    <other_outcome>
      <measure>Intensity of pain after surgery.</measure>
      <time_frame>During the first 4 postoperative days.</time_frame>
      <description>Intensity of pain will be assessed with the Numeric Rating Scale (NRS; an 11-point scale where 0=no pain and 10=the worst pain) twice daily during the first 4 postoperative days.</description>
    </other_outcome>
    <other_outcome>
      <measure>Subjective sleep quality after surgery.</measure>
      <time_frame>During the first 4 postoperative days.</time_frame>
      <description>Subjective sleep quality will be assessed with the Numeric Rating Scale (NRS; an 11-point scale where 0=the best sleep and 10=the worst sleep) once daily during the first 4 postoperative days.</description>
    </other_outcome>
    <other_outcome>
      <measure>Length of stay in hospital after surgery.</measure>
      <time_frame>Up to 30 days after surgery.</time_frame>
      <description>Length of stay in hospital after surgery.</description>
    </other_outcome>
    <other_outcome>
      <measure>Incidence of postoperative complications within 30 days.</measure>
      <time_frame>Up to 30 days after surgery.</time_frame>
      <description>Postoperative complications are defined as new-onset medical events other than delirium that are deemed harmful and require therapeutic intervention, that is grade II or higher on the Clavien-Dindo classification.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">4532</enrollment>
    <condition>Elderly</condition>
    <condition>Cancer Surgery</condition>
    <condition>Dexmedetomidine</condition>
    <condition>Long-Term Survivors</condition>
    <arm_group>
      <arm_group_label>Dexmedetomidine group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A loading dose of dexmedetomidine (0.6 μg/kg) will be administered over 10-15 minutes before anaesthesia induction, followed by a continuous infusion at a rate of 0.5 μg/kg/h till 1 hour before the end of surgery. Patient-controlled dexmedetomidine supplemented sufentanil analgesia will be provided after surgery: the formula contains a mixture of sufentanil (1.25 μg/ml) and dexmedetomidine (1.25 μg/ml), diluted with normal saline to a total volume of 160 ml; the analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with patient-controlled bolus of 2 ml each time and a lockout time of 8 minutes.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Volume-matched normal saline will be administered in the same rate and volume for the same duration as in the dexmedetomidine group during anesthesia. Patient-controlled sufentanil analgesia will be provided after surgery: the formula contains sufentanil (1.25 μg/ml), diluted with normal saline to a total volume of 160 ml; the analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with patient-controlled bolus of 2 ml each time and a lockout time of 8 minutes.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dexmedetomidine</intervention_name>
      <description>A loading dose of dexmedetomidine (0.6 μg/kg) will be administered over 10-15 minutes before anaesthesia induction, followed by a continuous infusion at a rate of 0.5 μg/kg/hr till 1 hour before the end of surgery. Patient-controlled dexmedetomidine supplemented sufentanil analgesia will be provided after surgery: the formula contains a mixture of sufentanil (1.25 μg/ml) and dexmedetomidine (1.25 μg/ml), diluted with normal saline to a total volume of 160 ml; the analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with patient-controlled bolus of 2 ml each time and a lockout time of 8 minutes.</description>
      <arm_group_label>Dexmedetomidine group</arm_group_label>
      <other_name>Dexmedetomidine hydrochloride</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Volume-matched normal saline will be administered in the same rate and volume for the same duration as in the dexmedetomidine group during anesthesia. Patient-controlled sufentanil analgesia will be provided after surgery: the formula contains sufentanil (1.25 μg/ml), diluted with normal saline to a total volume of 160 ml; the analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with patient-controlled bolus of 2 ml each time and a lockout time of 8 minutes.</description>
      <arm_group_label>Control group</arm_group_label>
      <other_name>Normal saline</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            1. Aged 60 years or older.&#xD;
  &#xD;
            2. Scheduled to undergo radical surgery for cancer under general anesthesia, with an&#xD;
               expected surgical duration of 2 hours or longer.&#xD;
  &#xD;
            3. Required patient-controlled intravenous analgesia after surgery.&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            1. Inability to communicate preoperatively due to visual, auditory, verbal. or other&#xD;
               reasons.&#xD;
  &#xD;
            2. Surgery for breast cancer or intracranial tumor.&#xD;
  &#xD;
            3. Preoperative severe sinus bradycardia (&lt;50 beats per minute), sick sinus syndrome，or&#xD;
               second-degree or above atrioventricular block without pacemaker.&#xD;
  &#xD;
            4. Severe hepatic dysfunction (Child-Pugh class C).&#xD;
  &#xD;
            5. Severe renal dysfunction (requirement of renal replacement therapy before surgery).&#xD;
  &#xD;
            6. Enrolled in other clinical studies.&#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>Dong-Xin Wang, MD,PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Peking University First Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dong-Xin Wang, MD,PhD</last_name>
      <phone>8610 83572784</phone>
      <email>wangdongxin@hotmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jia-Hui Ma, PhD</last_name>
      <phone>8610 83575138</phone>
      <email>mjh@bjmu.edu.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Peking University First Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing, China</state>
          <zip>100034</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Dong-Xin Wang, MD, PhD</last_name>
        <phone>8610 83572784</phone>
        <email>wangdongxin@hotmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Jia-Hui Ma, PhD</last_name>
        <phone>8610 83575138</phone>
        <email>mjh@bjmu.edu.cn</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Xijing Hospital, Fourth Military Medical University</name>
        <address>
          <city>Xi'an</city>
          <state>Shaanxi</state>
          <zip>710032</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Hai-Long Dong, MD</last_name>
        <phone>+86 13669226699</phone>
        <email>hldong6@hotmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Zhi-Hong Lu</last_name>
        <phone>+86 13891975018</phone>
        <email>deerlu23@163.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Shanghai Fourth People's Hospital Affiliated to Tongji University School of Medicine</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200123</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Lize Xiong, MD</last_name>
        <phone>+86 13609283068</phone>
        <email>mzkxlz@126.com</email>
      </contact>
      <contact_backup>
        <last_name>Xiya Yu, MD</last_name>
        <phone>+86 13764210333</phone>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
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      <citation>Lavon H, Matzner P, Benbenishty A, Sorski L, Rossene E, Haldar R, Elbaz E, Cata JP, Gottumukkala V, Ben-Eliyahu S. Dexmedetomidine promotes metastasis in rodent models of breast, lung, and colon cancers. Br J Anaesth. 2018 Jan;120(1):188-196. doi: 10.1016/j.bja.2017.11.004. Epub 2017 Nov 23.</citation>
      <PMID>29397129</PMID>
    </reference>
    <reference>
      <citation>Xing MW, Li CJ, Guo C, Wang BJ, Mu DL, Wang DX. Effect of intraoperative dexmedetomidine on long-term survival in older patients after major noncardiac surgery: 3-year follow-up of a randomized trial. J Clin Anesth. 2023 Jun;86:111068. doi: 10.1016/j.jclinane.2023.111068. Epub 2023 Feb 1.</citation>
      <PMID>36736209</PMID>
    </reference>
    <reference>
      <citation>Austin PC. An Introduction to Propensity Score Methods for Reducing the Effects of Confounding in Observational Studies. Multivariate Behav Res. 2011 May;46(3):399-424. doi: 10.1080/00273171.2011.568786. Epub 2011 Jun 8.</citation>
      <PMID>21818162</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 3, 2023</study_first_submitted>
    <study_first_submitted_qc>September 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Peking University First Hospital</investigator_affiliation>
      <investigator_full_name>Dong-Xin Wang</investigator_full_name>
      <investigator_title>Professor and Chairman, Department of Anesthesiology</investigator_title>
    </responsible_party>
    <keyword>Older patients</keyword>
    <keyword>Cancer surgery</keyword>
    <keyword>Dexmedetomidine</keyword>
    <keyword>Long-term survival</keyword>
    <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>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06030804
  org study id: 2023-227
  nct id: NCT06030804
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Along with aging population, cancer incidence and mortality are increasing. However, despite
        advances in oncology and surgery, long-term survival of cancer patients is far from optimal.
        Dexmedetomidine is a highly selective alpha 2 adrenergic receptor agonist with sedative,
        analgesic, and anxiolytic effects. Studies showed that perioperative use of dexmedetomidine
        reduces delirium and some non-delirium complications after surgery. In long-term follow-up
        studies of older patients who, for other reasons, were randomized to receive either
        dexmedetomidine or placebo during intra- or postoperative period, dexmedetomidine use was
        associated with improved long-term survival. This multicenter randomized trial aims to
        investigate the effect of perioperative dexmedetomidine on long-term outcomes in older
        patients undergoing cancer surgery.
  Along with aging population, cancer incidence and mortality are increasing. Surgical
        resection remains the mainstay treatment for solid organ cancer. However, despite advances in
        oncology and surgery, long-term survival of cancer patients is far from optimal. For example,
        the 5-year survival rate of cancer patients is about 36.9% in China, and the survival rate
        decreases for about 10% each year in older patients after cancer surgery. How to improve
        long-term survival after cancer surgery remains an urgent problem to be solved.
  
        Cancer death usually occur after cancer recurrence or metastasis. The development of cancer
        recurrence or metastasise after surgical resection depends on the balance between the
        anti-cancer defense function of host and the invasiveness of residual cancer cells. Studies
        showed that surgery, while resecting cancer mass, also releases cancer cells into the
        circulation. Surgical stress also impairs cell-mediated immunity and promote cancer growth.
  
        Dexmedetomidine is a highly selective alpha 2 adrenergic receptor agonist with sedative,
        analgesic, and anxiolytic effects. Studies showed that intraoperative use of dexmedetomidine
        reduces anesthetic and opioid consumption and relieves surgery-related stress response and
        inflammation. Studies also showed that perioperative use of dexmedetomidine reduces delirium,
        a commonly occurred complication in older patients, and some non-delirium complications after
        surgery.
  
        The effect of perioperative dexmedetomidine on long-term outcomes after cancer surgery
        remains unclear. In a long-term follow-up of older patients who were randomized to receive
        either low-dose dexmedetomidine or placebo during intensive care unit stay, dexmedetomidine
        use was associated with improved survival within 2 years. In a recent long-term follow-up of
        older patients who were randomized to receive either dexmedetomidine or placebo during
        surgery, dexmedetomidine use was associated with improved recurrence-free survival.
  
        The investigators hypothesize that perioperative use of dexmedetomidine may improve long-term
        survival after cancer surgery. This multicenter randomized trial aims to investigate the
        effect of perioperative dexmedetomidine on long-term outcomes in older patients undergoing
        cancer surgery.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Overall survival after surgery
  time frame: Up to 3 years after surgery of the last enrolled patient.
  description: Time interval from index surgery to all-cause death.
  measure: Progression-free survival after surgery
  time frame: Up to 3 years after surgery of the last enrolled patient.
  description: Time interval from index surgery to cancer recurrence/metastasis/progression or all-cause death, whichever comes first.
  measure: Event-free survival after surgery
  time frame: Up to 3 years after surgery of the last enrolled patient.
  description: Time interval from index surgery to cancer recurrence/metastasis/progression, new-onset cancer, new-onset serious illness (requiring hospitalization), or all-cause death, whichever comes first.
  measure: Cancer-specific survival after surgery
  time frame: Up to 3 years after surgery of the last enrolled patient.
  description: Time interval from index surgery to cancer-specific death, with deaths from other causes being censored at the time of death. Cancer-specific death is defined as death fully attributable to the cancer for which the index surgery is performed and usually involves cancer recurrence/metastasis/progression after exclusion of other causes such as stroke and myocardial infarction.
  measure: Rate of intensive care unit (ICU) admission after surgery.
  time frame: Up to 30 days after surgery.
  description: Percentage of patients who required ICU admission within 30 days after surgery.
  measure: Incidence of postoperative delirium.
  time frame: During the first 4 postoperative days.
  description: Delirium will be assessed with the 3D-Confusion Assessment Method (3D-CAM) or CAM for the Intensive Care Unit (CAM-ICU) twice daily during the first 4 postoperative days.
  measure: Intensity of pain after surgery.
  time frame: During the first 4 postoperative days.
  description: Intensity of pain will be assessed with the Numeric Rating Scale (NRS; an 11-point scale where 0=no pain and 10=the worst pain) twice daily during the first 4 postoperative days.
  measure: Subjective sleep quality after surgery.
  time frame: During the first 4 postoperative days.
  description: Subjective sleep quality will be assessed with the Numeric Rating Scale (NRS; an 11-point scale where 0=the best sleep and 10=the worst sleep) once daily during the first 4 postoperative days.
  measure: Length of stay in hospital after surgery.
  time frame: Up to 30 days after surgery.
  description: Length of stay in hospital after surgery.
  measure: Incidence of postoperative complications within 30 days.
  time frame: Up to 30 days after surgery.
  description: Postoperative complications are defined as new-onset medical events other than delirium that are deemed harmful and require therapeutic intervention, that is grade II or higher on the Clavien-Dindo classification.
  arm group label: Dexmedetomidine group
  arm group type: Experimental
  description: A loading dose of dexmedetomidine (0.6 μg/kg) will be administered over 10-15 minutes before anaesthesia induction, followed by a continuous infusion at a rate of 0.5 μg/kg/h till 1 hour before the end of surgery. Patient-controlled dexmedetomidine supplemented sufentanil analgesia will be provided after surgery: the formula contains a mixture of sufentanil (1.25 μg/ml) and dexmedetomidine (1.25 μg/ml), diluted with normal saline to a total volume of 160 ml; the analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with patient-controlled bolus of 2 ml each time and a lockout time of 8 minutes.
  arm group label: Control group
  arm group type: Placebo Comparator
  description: Volume-matched normal saline will be administered in the same rate and volume for the same duration as in the dexmedetomidine group during anesthesia. Patient-controlled sufentanil analgesia will be provided after surgery: the formula contains sufentanil (1.25 μg/ml), diluted with normal saline to a total volume of 160 ml; the analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with patient-controlled bolus of 2 ml each time and a lockout time of 8 minutes.
  intervention type: Drug
  intervention name: Dexmedetomidine
  description: A loading dose of dexmedetomidine (0.6 μg/kg) will be administered over 10-15 minutes before anaesthesia induction, followed by a continuous infusion at a rate of 0.5 μg/kg/hr till 1 hour before the end of surgery. Patient-controlled dexmedetomidine supplemented sufentanil analgesia will be provided after surgery: the formula contains a mixture of sufentanil (1.25 μg/ml) and dexmedetomidine (1.25 μg/ml), diluted with normal saline to a total volume of 160 ml; the analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with patient-controlled bolus of 2 ml each time and a lockout time of 8 minutes.
  arm group label: Dexmedetomidine group
  other name: Dexmedetomidine hydrochloride
  intervention type: Drug
  intervention name: Placebo
  description: Volume-matched normal saline will be administered in the same rate and volume for the same duration as in the dexmedetomidine group during anesthesia. Patient-controlled sufentanil analgesia will be provided after surgery: the formula contains sufentanil (1.25 μg/ml), diluted with normal saline to a total volume of 160 ml; the analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with patient-controlled bolus of 2 ml each time and a lockout time of 8 minutes.
  arm group label: Control group
  other name: Normal saline
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Dong-Xin Wang, MD,PhD
  role: Principal Investigator
  affiliation: Peking University First Hospital
  last name: Dong-Xin Wang, MD,PhD
  phone: 8610 83572784
  email: wangdongxin@hotmail.com
  last name: Jia-Hui Ma, PhD
  phone: 8610 83575138
  email: mjh@bjmu.edu.cn
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  facility: 
  status: Not yet recruiting
  contact: 
  contact backup: 
  facility: 
  status: Not yet recruiting
  contact: 
  contact backup: 
  country: China
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  citation: Lavon H, Matzner P, Benbenishty A, Sorski L, Rossene E, Haldar R, Elbaz E, Cata JP, Gottumukkala V, Ben-Eliyahu S. Dexmedetomidine promotes metastasis in rodent models of breast, lung, and colon cancers. Br J Anaesth. 2018 Jan;120(1):188-196. doi: 10.1016/j.bja.2017.11.004. Epub 2017 Nov 23.
  PMID: 29397129
  citation: Xing MW, Li CJ, Guo C, Wang BJ, Mu DL, Wang DX. Effect of intraoperative dexmedetomidine on long-term survival in older patients after major noncardiac surgery: 3-year follow-up of a randomized trial. J Clin Anesth. 2023 Jun;86:111068. doi: 10.1016/j.jclinane.2023.111068. Epub 2023 Feb 1.
  PMID: 36736209
  citation: Austin PC. An Introduction to Propensity Score Methods for Reducing the Effects of Confounding in Observational Studies. Multivariate Behav Res. 2011 May;46(3):399-424. doi: 10.1080/00273171.2011.568786. Epub 2011 Jun 8.
  PMID: 21818162
  responsible party type: Principal Investigator
  investigator affiliation: Peking University First Hospital
  investigator full name: Dong-Xin Wang
  investigator title: Professor and Chairman, Department of Anesthesiology
  mesh term: Dexmedetomidine
  sharing ipd: No