<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/NCT03012984</url>
  </required_header>
  <id_info>
    <org_study_id>2016-10</org_study_id>
    <nct_id>NCT03012984</nct_id>
  </id_info>
  <brief_title>Dexmedetomidine Supplemented Analgesia and Incidence of Postoperative Delirium</brief_title>
  <official_title>Impact of Dexmedetomidine Supplemented Analgesia on Incidence of Delirium in Elderly Patients After Cancer Surgery: a Multicenter Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University First Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Affiliated Hospital of Hebei University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Qingdao Municipal Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second Affiliated Hospital of Air Force Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking University International Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Guizhou Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Third Xiangya Hospital of Central South University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanxi Provincial Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tianjin Hospital of ITCWM-Nankai Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zhongda Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chongqing University Fuling Hospital</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>
      Delirium is a frequently occurred cerebral complication in elderly patients after surgery,&#xD;
      and its occurrence is associated with worse outcomes. Sleep disturbances is considered to be&#xD;
      one of the most important risk factors of postoperative delirium. Previous studies showed&#xD;
      that, for elderly patients admitted to the ICU after surgery, low-dose dexmedetomidine&#xD;
      infusion improved the quality of sleep and decreased the incidence of delirium. The&#xD;
      investigators hypothesize that, for elderly patients after cancer surgery, dexmedetomidine&#xD;
      supplemented analgesia can also decrease the incidence of delirium, possibly by improving&#xD;
      sleep quality. The purpose of this multicenter, randomized controlled trial is to investigate&#xD;
      the impact of dexmedetomidine supplemented analgesia on the incidence of delirium in elderly&#xD;
      patients after cancer surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Delirium is a state of acutely occurred and transient cerebral dysfunction. It is a common&#xD;
      complication in elderly patients after surgery. A systematic review showed that an average of&#xD;
      36.8% (range 0 to 73.5%) of surgical patients developed postoperative delirium, and its&#xD;
      occurrence increased with age. According to our previous studies, postoperative delirium&#xD;
      developed in 51.0% of patients after cardiac surgery and in 44.5% of patients after&#xD;
      non-cardiac surgery. The occurrence of delirium is associated with worse short-term outcomes,&#xD;
      including increased postoperative complications, prolonged hospital stay, and increased&#xD;
      in-hospital mortality; it is also associated with worse long-term outcomes, including&#xD;
      declined cognitive function, decreased quality of life, and increased post-hospital&#xD;
      mortality. Delirium is the result of multiple factors. Studies showed that postoperative pain&#xD;
      is an important risk factor of delirium, whereas good postoperative analgesia reduces the&#xD;
      incidence of delirium. For postoperative patients, sleep disturbances occurs frequently and&#xD;
      increases the risk of delirium, whereas improving sleep quality reduces the incidence of&#xD;
      delirium. Furthermore, the studies found that surgery related inflammatory response also&#xD;
      plays an important role in the development of delirium.&#xD;
&#xD;
      Dexmedetomidine is a highly selective alpha-2 (α2) adrenoreceptor agonist that provides&#xD;
      anxiolysis, sedation, hypnosis and analgesia. It exerts the sedative and hypnotic effects by&#xD;
      activating the endogenous sleep pathways, and produces a condition similar to phase 2&#xD;
      non-rapid eye movement sleep. For patients undergoing mechanical ventilation in the ICU,&#xD;
      dexmedetomidine sedation helps to maintain a normal circadian rhythm of sleep and improves&#xD;
      sleep architecture. Dexmedetomidine also provides analgesic effect by activating α2&#xD;
      adrenergic receptors in the dorsal horn of spinal cord. When used as a supplemental drug it&#xD;
      decreases intraoperative and postoperative requirement of opioids. Moreover, animal studies&#xD;
      showed that dexmedetomidine significantly inhibits the degree of inflammatory response&#xD;
      induced by endotoxin or during spinal cord injury. In clinical studies, dexmedetomidine&#xD;
      attenuates the degree of inflammatory response following Coronary Artery Bypass Grafting&#xD;
      surgery.&#xD;
&#xD;
      These effects of dexmedetomidine make it suitable for prevention of postoperative delirium in&#xD;
      high-risk patients. Studies have shown that, for ICU patients requiring mechanical&#xD;
      ventilation, sedation with dexmedetomidine reduces the incidence of delirium when compared&#xD;
      with other sedatives; for postoperative patients, dexmedetomidine administered in combined&#xD;
      with opioids improves analgesia and reduces opioid requirements. A recent study showed that,&#xD;
      for elderly patients admitted to the ICU after surgery, low-dose dexmedetomidine infusion (at&#xD;
      a rate of 0.1 ug/kg/h, for an average of 15 hours) improves analgesia for up to 24 hours,&#xD;
      ameliorates subjective sleep quality for up to 3 days, and reduces the incidence of delirium&#xD;
      during the first 7 postoperative days. The investigators hypothesized that the use of&#xD;
      dexmedetomidine as a supplement to patient-controlled intravenous analgesia may also reduce&#xD;
      the incidence of postoperative delirium.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 6, 2017</start_date>
  <completion_date type="Actual">June 11, 2022</completion_date>
  <primary_completion_date type="Actual">May 12, 2022</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>Incidence of delirium within 5 days after surgery</measure>
    <time_frame>During the first 5 days after surgery</time_frame>
    <description>Incidence of delirium within 5 days after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Daily prevalence of delirium during the first 5 postoperative days</measure>
    <time_frame>During the first 5 postoperative days</time_frame>
    <description>Daily prevalence of delirium during the first 5 postoperative days</description>
  </secondary_outcome>
  <secondary_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>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of non-delirium complications after surgery</measure>
    <time_frame>Up to 30 days after surgery</time_frame>
    <description>Incidence of non-delirium complications after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-day all-cause mortality after surgery</measure>
    <time_frame>At the time of 30 days after surgery</time_frame>
    <description>30-day all-cause mortality after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life in survival patients on the 30th day after surgery</measure>
    <time_frame>On the 30th day after surgery</time_frame>
    <description>Assessed with World Health Organization Quality of Life-Bref (WHOQOL-BREF)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function in survival patients on the 30th day after surgery</measure>
    <time_frame>On the 30th day after surgery</time_frame>
    <description>Assessed with Telephone Interview for Cognitive Status-Modified (TICS-M)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Richmond Agitation-Sedation Scale (RASS) score during the first 5 days after surgery</measure>
    <time_frame>During the first 5 days after surgery</time_frame>
    <description>Richmond Agitation-Sedation Scale (RASS) score during the first 5 days after surgery</description>
  </other_outcome>
  <other_outcome>
    <measure>Cumulative morphine consumption during the first 3 days after surgery</measure>
    <time_frame>During the first 3 days after surgery</time_frame>
    <description>Cumulative morphine consumption during the first 3 days after surgery</description>
  </other_outcome>
  <other_outcome>
    <measure>Numeric Rating Scale (NRS) pain score during the first 5 days after surgery</measure>
    <time_frame>During the first 5 days after surgery</time_frame>
    <description>Numeric Rating Scale (NRS) pain score during the first 5 days after surgery</description>
  </other_outcome>
  <other_outcome>
    <measure>Numeric Rating Scale (NRS) sleep quality score during the first 5 days after surgery</measure>
    <time_frame>During the first 5 days after surgery</time_frame>
    <description>Numeric Rating Scale (NRS) sleep quality score during the first 5 days after surgery</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1500</enrollment>
  <condition>Elderly</condition>
  <condition>Surgery</condition>
  <condition>Analgesia</condition>
  <condition>Dexmedetomidine</condition>
  <condition>Complication, Postoperative</condition>
  <condition>Delirium</condition>
  <arm_group>
    <arm_group_label>Dexmedetomidine group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dexmedetomidine supplemented morphine analgesia will be provided for patients in this group in the form of patient-controlled intravenous analgesia. The formula contains a mixture of morphine (0.5 mg/ml) and dexmedetomidine (1.25 ug/ml), diluted with normal saline to a total volume of 160 ml. 5-HT3 receptor antagonist is added when necessary. 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 from 6 to 8 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Morphine analgesia will be provided for patients in this group in the form of patient-controlled intravenous analgesia. The formula contains morphine (0.5 mg/ml), diluted with normal saline to a total volume of 160 ml. 5-HT3 receptor antagonist is added when necessary. 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 from 6 to 8 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine supplemented morphine analgesia</intervention_name>
    <description>Patients in this group will receive patient-controlled intravenous analgesia for 3 days after surgery. The formula is a mixture of dexmedetomidine (1.25 ug/ml) and morphine (0.5 mg/ml), diluted with normal saline to 160 ml. 5-HT3 receptor antagonist is added when necessary. The analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with a bolus dose of 2 ml each time and a lockout time from 6 to 8 minutes according to patients' condition.</description>
    <arm_group_label>Dexmedetomidine group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Morphine analgesia</intervention_name>
    <description>Patients in this group will receive patient-controlled intravenous analgesia for 3 days after surgery. The formula is morphine (0.5 mg/ml) diluted with normal saline to 160 ml. 5-HT3 receptor antagonist is added when necessary. The analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with a bolus dose of 2 ml each time and a lockout time from 6 to 8 minutes according to patients' condition.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;= 65 years, &lt; 90 years;&#xD;
&#xD;
          -  Scheduled to undergo surgery for primary solid organ cancer under general anesthesia,&#xD;
             with an expected duration of surgery &gt;=2 hours;&#xD;
&#xD;
          -  Planned to use patient-controlled intravenous analgesia after surgery;&#xD;
&#xD;
          -  Provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preoperative history of schizophrenia, epilepsy, parkinsonism or myasthenia gravis;&#xD;
&#xD;
          -  Preoperative radio- or chemotherapy;&#xD;
&#xD;
          -  Inability to communicate in the preoperative period because of coma, profound dementia&#xD;
             or language barrier;&#xD;
&#xD;
          -  Preoperative obstructive sleep apnea (previously diagnosed as obstructive sleep apnea,&#xD;
             or a STOP-Bang score &gt;= 3);&#xD;
&#xD;
          -  Brain trauma or neurosurgery;&#xD;
&#xD;
          -  Preoperative left ventricular ejection fraction &lt; 30%, sick sinus syndrome, severe&#xD;
             sinus bradycardia (&lt; 50 beats per minute), or second-degree or above atrioventricular&#xD;
             block without pacemaker;&#xD;
&#xD;
          -  Severe hepatic dysfunction (Child-Pugh class C) or severe renal dysfunction&#xD;
             (requirement of renal replacement therapy before surgery);&#xD;
&#xD;
          -  ASA classification &gt;= IV.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>90 Years</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>
  <location>
    <facility>
      <name>Peking University First Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100034</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking University International Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>102206</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chongqing University Fuling Hospital</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>408099</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guizhou Provincial People's Hospital</name>
      <address>
        <city>Guiyang</city>
        <state>Guizhou</state>
        <zip>550002</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Affiliated Hospital of Hebei University</name>
      <address>
        <city>Baoding</city>
        <state>Hebei</state>
        <zip>050031</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Third Xiangya Hospital of Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhongda Hospital Southeast University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Air Force Medical University</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710038</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qingdao Municipal Hospital</name>
      <address>
        <city>Qingdao</city>
        <state>Shandong</state>
        <zip>266011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanxi Provincial Cancer Hospital</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <zip>030013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Hospital of ITCWM-Nankai Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300100</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
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  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 31, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>July 30, 2023</last_update_submitted>
  <last_update_submitted_qc>July 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 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 and Critical Care Medicine</investigator_title>
  </responsible_party>
  <keyword>elderly</keyword>
  <keyword>surgery</keyword>
  <keyword>analgesia</keyword>
  <keyword>dexmedetomidine</keyword>
  <keyword>delirium</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
    <mesh_term>Postoperative Complications</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</mesh_term>
    <mesh_term>Morphine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03012984
org study id: 2016-10
nct id: NCT03012984
lead sponsor: 
collaborator: 
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has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Delirium is a frequently occurred cerebral complication in elderly patients after surgery,
      and its occurrence is associated with worse outcomes. Sleep disturbances is considered to be
      one of the most important risk factors of postoperative delirium. Previous studies showed
      that, for elderly patients admitted to the ICU after surgery, low-dose dexmedetomidine
      infusion improved the quality of sleep and decreased the incidence of delirium. The
      investigators hypothesize that, for elderly patients after cancer surgery, dexmedetomidine
      supplemented analgesia can also decrease the incidence of delirium, possibly by improving
      sleep quality. The purpose of this multicenter, randomized controlled trial is to investigate
      the impact of dexmedetomidine supplemented analgesia on the incidence of delirium in elderly
      patients after cancer surgery.
Delirium is a state of acutely occurred and transient cerebral dysfunction. It is a common
      complication in elderly patients after surgery. A systematic review showed that an average of
      36.8% (range 0 to 73.5%) of surgical patients developed postoperative delirium, and its
      occurrence increased with age. According to our previous studies, postoperative delirium
      developed in 51.0% of patients after cardiac surgery and in 44.5% of patients after
      non-cardiac surgery. The occurrence of delirium is associated with worse short-term outcomes,
      including increased postoperative complications, prolonged hospital stay, and increased
      in-hospital mortality; it is also associated with worse long-term outcomes, including
      declined cognitive function, decreased quality of life, and increased post-hospital
      mortality. Delirium is the result of multiple factors. Studies showed that postoperative pain
      is an important risk factor of delirium, whereas good postoperative analgesia reduces the
      incidence of delirium. For postoperative patients, sleep disturbances occurs frequently and
      increases the risk of delirium, whereas improving sleep quality reduces the incidence of
      delirium. Furthermore, the studies found that surgery related inflammatory response also
      plays an important role in the development of delirium.

      Dexmedetomidine is a highly selective alpha-2 (α2) adrenoreceptor agonist that provides
      anxiolysis, sedation, hypnosis and analgesia. It exerts the sedative and hypnotic effects by
      activating the endogenous sleep pathways, and produces a condition similar to phase 2
      non-rapid eye movement sleep. For patients undergoing mechanical ventilation in the ICU,
      dexmedetomidine sedation helps to maintain a normal circadian rhythm of sleep and improves
      sleep architecture. Dexmedetomidine also provides analgesic effect by activating α2
      adrenergic receptors in the dorsal horn of spinal cord. When used as a supplemental drug it
      decreases intraoperative and postoperative requirement of opioids. Moreover, animal studies
      showed that dexmedetomidine significantly inhibits the degree of inflammatory response
      induced by endotoxin or during spinal cord injury. In clinical studies, dexmedetomidine
      attenuates the degree of inflammatory response following Coronary Artery Bypass Grafting
      surgery.

      These effects of dexmedetomidine make it suitable for prevention of postoperative delirium in
      high-risk patients. Studies have shown that, for ICU patients requiring mechanical
      ventilation, sedation with dexmedetomidine reduces the incidence of delirium when compared
      with other sedatives; for postoperative patients, dexmedetomidine administered in combined
      with opioids improves analgesia and reduces opioid requirements. A recent study showed that,
      for elderly patients admitted to the ICU after surgery, low-dose dexmedetomidine infusion (at
      a rate of 0.1 ug/kg/h, for an average of 15 hours) improves analgesia for up to 24 hours,
      ameliorates subjective sleep quality for up to 3 days, and reduces the incidence of delirium
      during the first 7 postoperative days. The investigators hypothesized that the use of
      dexmedetomidine as a supplement to patient-controlled intravenous analgesia may also reduce
      the incidence of postoperative delirium.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Incidence of delirium within 5 days after surgery
time frame: During the first 5 days after surgery
description: Incidence of delirium within 5 days after surgery
measure: Daily prevalence of delirium during the first 5 postoperative days
time frame: During the first 5 postoperative days
description: Daily prevalence of delirium during the first 5 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 non-delirium complications after surgery
time frame: Up to 30 days after surgery
description: Incidence of non-delirium complications after surgery
measure: 30-day all-cause mortality after surgery
time frame: At the time of 30 days after surgery
description: 30-day all-cause mortality after surgery
measure: Quality of life in survival patients on the 30th day after surgery
time frame: On the 30th day after surgery
description: Assessed with World Health Organization Quality of Life-Bref (WHOQOL-BREF)
measure: Cognitive function in survival patients on the 30th day after surgery
time frame: On the 30th day after surgery
description: Assessed with Telephone Interview for Cognitive Status-Modified (TICS-M)
measure: Richmond Agitation-Sedation Scale (RASS) score during the first 5 days after surgery
time frame: During the first 5 days after surgery
description: Richmond Agitation-Sedation Scale (RASS) score during the first 5 days after surgery
measure: Cumulative morphine consumption during the first 3 days after surgery
time frame: During the first 3 days after surgery
description: Cumulative morphine consumption during the first 3 days after surgery
measure: Numeric Rating Scale (NRS) pain score during the first 5 days after surgery
time frame: During the first 5 days after surgery
description: Numeric Rating Scale (NRS) pain score during the first 5 days after surgery
measure: Numeric Rating Scale (NRS) sleep quality score during the first 5 days after surgery
time frame: During the first 5 days after surgery
description: Numeric Rating Scale (NRS) sleep quality score during the first 5 days after surgery
arm group label: Dexmedetomidine group
arm group type: Experimental
description: Dexmedetomidine supplemented morphine analgesia will be provided for patients in this group in the form of patient-controlled intravenous analgesia. The formula contains a mixture of morphine (0.5 mg/ml) and dexmedetomidine (1.25 ug/ml), diluted with normal saline to a total volume of 160 ml. 5-HT3 receptor antagonist is added when necessary. 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 from 6 to 8 minutes.
arm group label: Control group
arm group type: Placebo Comparator
description: Morphine analgesia will be provided for patients in this group in the form of patient-controlled intravenous analgesia. The formula contains morphine (0.5 mg/ml), diluted with normal saline to a total volume of 160 ml. 5-HT3 receptor antagonist is added when necessary. 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 from 6 to 8 minutes.
intervention type: Drug
intervention name: Dexmedetomidine supplemented morphine analgesia
description: Patients in this group will receive patient-controlled intravenous analgesia for 3 days after surgery. The formula is a mixture of dexmedetomidine (1.25 ug/ml) and morphine (0.5 mg/ml), diluted with normal saline to 160 ml. 5-HT3 receptor antagonist is added when necessary. The analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with a bolus dose of 2 ml each time and a lockout time from 6 to 8 minutes according to patients' condition.
arm group label: Dexmedetomidine group
intervention type: Drug
intervention name: Morphine analgesia
description: Patients in this group will receive patient-controlled intravenous analgesia for 3 days after surgery. The formula is morphine (0.5 mg/ml) diluted with normal saline to 160 ml. 5-HT3 receptor antagonist is added when necessary. The analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with a bolus dose of 2 ml each time and a lockout time from 6 to 8 minutes according to patients' condition.
arm group label: Control group
criteria: 
gender: All
minimum age: 65 Years
maximum age: 90 Years
healthy volunteers: No
last name: Dong-Xin Wang, MD,PhD
role: Principal Investigator
affiliation: Peking University First Hospital
facility: 
facility: 
facility: 
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country: China
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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 and Critical Care Medicine
mesh term: Delirium
mesh term: Postoperative Complications
mesh term: Dexmedetomidine
mesh term: Morphine
sharing ipd: No