<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/NCT03289325</url>
  </required_header>
  <id_info>
    <org_study_id>2016-1188</org_study_id>
    <nct_id>NCT03289325</nct_id>
  </id_info>
  <brief_title>Dexmedetomidine and Long-term Outcomes in Elderly Patients After Cardiac Surgery</brief_title>
  <official_title>Impact of Perioperative Dexmedetomidine on Long-term Outcomes in Elderly Patients After Cardiac Surgery: 6-year Follow-up of a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University First Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chinese Academy of Medical Sciences, Fuwai 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>
      A retrospective study showed that intraoperative dexmedetomidine administration was&#xD;
      associated with decreased risk of 1-year mortality after cardiac surgery. In a previous&#xD;
      randomized controlled trial, 285 elderly patients undergoing cardiac surgery were randomized&#xD;
      to receive either perioperative dexmedetomidine or placebo (normal saline) administration.&#xD;
      The purpose of this 6-year follow-up study is to investigate whether perioperative&#xD;
      dexmedetomidine can improve long-term outcomes in those recruited elderly patients after&#xD;
      cardiac surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dexmedetomidine is a highly selective alpha 2-adrenergic receptor agonist that provides&#xD;
      anti-anxiety, sedation, and modest analgesic effects. In a retrospective cohort study of&#xD;
      patients undergoing cardiac surgery, perioperative dexmedetomidine administration was&#xD;
      associated with decreased risk of 1-year mortality. Theoretically, perioperative&#xD;
      dexmedetomidine may exert the following favorable for cardiac surgery patients: (1) reduces&#xD;
      perioperative opioid consumption and thereby mitigates opioid-induced immunosuppression, (2)&#xD;
      dampens hyper-inflammatory response induced by surgery, and (3) improves postoperative sleep&#xD;
      quality. However, prospective studies investigating the long-term effects of perioperative&#xD;
      dexmedetomidine in cardiac surgery patients are still lacking.&#xD;
&#xD;
      In a previous randomized controlled trial, 285 patients of 60 years or older who were&#xD;
      scheduled to undergo coronary artery bypass graft surgery and/or valve replacement surgery&#xD;
      were randomized to receive either perioperative dexmedetomidine administration (0.6&#xD;
      microgram/kg in 10 minutes before anesthesia induction, followed by a continuous infusion at&#xD;
      a rate of 0.4 microgram/kg/h until the end of surgery, then a continuous infusion at a rate&#xD;
      of 0.1 microgram/kg/h until the end of mechanical ventilation) or placebo (normal saline,&#xD;
      administered in the same rate or volume for the same duration as in the dexmedetomidine&#xD;
      group). The results showed that perioperative dexmedetomidine reduced the incidence of&#xD;
      pulmonary complications and shortened the duration of mechanical ventilation after surgery.&#xD;
&#xD;
      The purpose of this 6-year follow-up study is to investigate the effects of perioperative&#xD;
      dexmedetomidine on the long-term outcomes in elderly patients after cardiac surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 1, 2016</start_date>
  <completion_date type="Anticipated">May 2022</completion_date>
  <primary_completion_date type="Anticipated">April 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>Overall survival after surgery</measure>
    <time_frame>Up to 6 years after surgery</time_frame>
    <description>Overall survival after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major adverse cardiovascular events-free survival after surgery</measure>
    <time_frame>Up to 6 years after surgery</time_frame>
    <description>Major adverse cardiovascular events include cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and myocardial revascularization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital-free survival after surgery</measure>
    <time_frame>Up to 6 years after surgery</time_frame>
    <description>Event indicates any medical condition that lead to hospitalization after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function in 6-year survivors after surgery</measure>
    <time_frame>At the 6th year after surgery</time_frame>
    <description>Cognitive function is assessed with Telephone Interview for Cognitive Status-Modified (TICS-M; scores range from 0 to 50, with higher score indicating better cognitive function).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life in 6-year survivors after surgery</measure>
    <time_frame>At the 6th year after surgery</time_frame>
    <description>Health related quality of life is assessed with the short-form 36-item health survey questionnaire (SF-36). The SF-36 scale measures eight aspects of health status, i.e., physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. It also measures changes of subjective healthy status during the last year (reported health transition). The scores of the above 9 items are calculated separately with scores range from 0 to 100, with higher score indicating better quality.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">285</enrollment>
  <condition>Cardiac Surgery</condition>
  <condition>Dexmedetomidine</condition>
  <condition>Long-term Outcome</condition>
  <condition>Mortality</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>DEX group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The active drug (dexmedetomidine hydrochloride for injection) will be administered during a period from before anesthesia induction until the end of mechanical ventilation after surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CTRL group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The placebo drug (normal saline, or 0.9% sodium chloride for injection) will be administered in the same rate and volume for a same duration as that in the DEX group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dexmedetomidine hydrochloride for injection</intervention_name>
    <description>Before anesthesia, dexmedetomidine hydrochloride for injection (200 ug/2 ml) will be diluted with normal saline to 50 ml (final dexmedetomidine concentration 4 ug/ml).&#xD;
Before anesthesia induction, a loading dose will be administered by intravenous infusion at a rate of [0.9*kg] ml/h for 10 minutes (i.e., dexmedetomidine 0.6 ug/kg in 10 minutes), followed by continuous infusion at a rate of [0.1*kg] ml/h (i.e., dexmedetomidine at a rate of 0.4 ug/kg/h) until the end of surgery.&#xD;
After surgery, the infusion rate will be decreased to [0.025*kg] ml/h (i.e., dexmedetomidine at a rate of 0.1 ug/kg/h) and continued until the end of mechanical ventilation.</description>
    <arm_group_label>DEX group</arm_group_label>
    <other_name>Aibeining (trade name)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.9% sodium chloride for injection</intervention_name>
    <description>Before anesthesia, 0.9% sodium chloride for injection 50 ml will be prepared.&#xD;
Before anesthesia induction, a loading dose will be administered by intravenous infusion at a rate of [0.9*kg] ml/h for 10 minutes, followed by continuous infusion at a rate of [0.1*kg] ml/h until the end of surgery.&#xD;
After surgery, the infusion rate will be decreased to [0.025*kg] ml/h and continued until the end of mechanical ventilation.</description>
    <arm_group_label>CTRL group</arm_group_label>
    <other_name>Normal saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age of 60 years or older;&#xD;
&#xD;
          2. Scheduled to undergo cardiac surgery (coronary artery bypass graft and/or valve&#xD;
             replacement surgery);&#xD;
&#xD;
          3. Provide written informed consents.&#xD;
&#xD;
        Exclusion Criteria: Patients who meet any of the following criteria will be excluded.&#xD;
&#xD;
          1. Preoperative history of schizophrenia, epilepsia, Parkinson syndrome, or severe&#xD;
             dementia;&#xD;
&#xD;
          2. Inability to communicate in the preoperative period because of severe visual/auditory&#xD;
             dysfunction or language barrier;&#xD;
&#xD;
          3. History of brain injury or neurosurgery;&#xD;
&#xD;
          4. Preoperative sick sinus syndrome, severe bradycardia (HR &lt; 50 bpm), second-degree or&#xD;
             above atrioventricular block without pacemaker;&#xD;
&#xD;
          5. Severe hepatic dysfunction (Child-Pugh class C);&#xD;
&#xD;
          6. Severe renal dysfunction (requirement of renal replacement therapy);&#xD;
&#xD;
          7. Other conditions that are considered unsuitable for participation.&#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>
  <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_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Guenther U, Radtke FM. Delirium in the postanaesthesia period. Curr Opin Anaesthesiol. 2011 Dec;24(6):670-5. doi: 10.1097/ACO.0b013e32834c7b44.</citation>
    <PMID>21971396</PMID>
  </reference>
  <reference>
    <citation>Morandi A, Pandharipande PP, Jackson JC, Bellelli G, Trabucchi M, Ely EW. Understanding terminology of delirium and long-term cognitive impairment in critically ill patients. Best Pract Res Clin Anaesthesiol. 2012 Sep;26(3):267-76. doi: 10.1016/j.bpa.2012.08.001.</citation>
    <PMID>23040280</PMID>
  </reference>
  <reference>
    <citation>Groen JA, Banayan D, Gupta S, Xu S, Bhalerao S. Treatment of delirium following cardiac surgery. J Card Surg. 2012 Sep;27(5):589-93. doi: 10.1111/j.1540-8191.2012.01508.x.</citation>
    <PMID>22978835</PMID>
  </reference>
  <reference>
    <citation>Ely EW, Gautam S, Margolin R, Francis J, May L, Speroff T, Truman B, Dittus R, Bernard R, Inouye SK. The impact of delirium in the intensive care unit on hospital length of stay. Intensive Care Med. 2001 Dec;27(12):1892-900. doi: 10.1007/s00134-001-1132-2. Epub 2001 Nov 8.</citation>
    <PMID>11797025</PMID>
  </reference>
  <reference>
    <citation>Girard TD, Shintani AK, Ely EW. Comment on &quot;Incidence, risk factors and consequences of ICU delirium&quot; by Ouimet et al. Intensive Care Med. 2007 Aug;33(8):1479-80; author reply 1481-2. doi: 10.1007/s00134-007-0698-8. Epub 2007 Jun 5. No abstract available.</citation>
    <PMID>17549453</PMID>
  </reference>
  <reference>
    <citation>Thomason JW, Shintani A, Peterson JF, Pun BT, Jackson JC, Ely EW. Intensive care unit delirium is an independent predictor of longer hospital stay: a prospective analysis of 261 non-ventilated patients. Crit Care. 2005 Aug;9(4):R375-81. doi: 10.1186/cc3729. Epub 2005 Jun 1.</citation>
    <PMID>16137350</PMID>
  </reference>
  <reference>
    <citation>Milbrandt EB, Deppen S, Harrison PL, Shintani AK, Speroff T, Stiles RA, Truman B, Bernard GR, Dittus RS, Ely EW. Costs associated with delirium in mechanically ventilated patients. Crit Care Med. 2004 Apr;32(4):955-62. doi: 10.1097/01.ccm.0000119429.16055.92.</citation>
    <PMID>15071384</PMID>
  </reference>
  <reference>
    <citation>Hopkins RO, Jackson JC. Short- and long-term cognitive outcomes in intensive care unit survivors. Clin Chest Med. 2009 Mar;30(1):143-53, ix. doi: 10.1016/j.ccm.2008.11.001.</citation>
    <PMID>19186286</PMID>
  </reference>
  <reference>
    <citation>Jackson JC, Gordon SM, Hart RP, Hopkins RO, Ely EW. The association between delirium and cognitive decline: a review of the empirical literature. Neuropsychol Rev. 2004 Jun;14(2):87-98. doi: 10.1023/b:nerv.0000028080.39602.17.</citation>
    <PMID>15264710</PMID>
  </reference>
  <reference>
    <citation>Vaurio LE, Sands LP, Wang Y, Mullen EA, Leung JM. Postoperative delirium: the importance of pain and pain management. Anesth Analg. 2006 Apr;102(4):1267-73. doi: 10.1213/01.ane.0000199156.59226.af.</citation>
    <PMID>16551935</PMID>
  </reference>
  <reference>
    <citation>Halaszynski TM. Pain management in the elderly and cognitively impaired patient: the role of regional anesthesia and analgesia. Curr Opin Anaesthesiol. 2009 Oct;22(5):594-9. doi: 10.1097/ACO.0b013e32833020dc.</citation>
    <PMID>19623056</PMID>
  </reference>
  <reference>
    <citation>Rudolph JL, Ramlawi B, Kuchel GA, McElhaney JE, Xie D, Sellke FW, Khabbaz K, Levkoff SE, Marcantonio ER. Chemokines are associated with delirium after cardiac surgery. J Gerontol A Biol Sci Med Sci. 2008 Feb;63(2):184-9. doi: 10.1093/gerona/63.2.184.</citation>
    <PMID>18314455</PMID>
  </reference>
  <reference>
    <citation>de Rooij SE, van Munster BC, Korevaar JC, Levi M. Cytokines and acute phase response in delirium. J Psychosom Res. 2007 May;62(5):521-5. doi: 10.1016/j.jpsychores.2006.11.013.</citation>
    <PMID>17467406</PMID>
  </reference>
  <reference>
    <citation>Roth-Isigkeit A, Borstel TV, Seyfarth M, Schmucker P. Perioperative serum levels of tumour-necrosis-factor alpha (TNF-alpha), IL-1 beta, IL-6, IL-10 and soluble IL-2 receptor in patients undergoing cardiac surgery with cardiopulmonary bypass without and with correction for haemodilution. Clin Exp Immunol. 1999 Nov;118(2):242-6. doi: 10.1046/j.1365-2249.1999.01050.x.</citation>
    <PMID>10540185</PMID>
  </reference>
  <reference>
    <citation>Holmes JH 4th, Connolly NC, Paull DL, Hill ME, Guyton SW, Ziegler SF, Hall RA. Magnitude of the inflammatory response to cardiopulmonary bypass and its relation to adverse clinical outcomes. Inflamm Res. 2002 Dec;51(12):579-86. doi: 10.1007/pl00012432.</citation>
    <PMID>12558191</PMID>
  </reference>
  <reference>
    <citation>Bidwell J. Interventions for preventing delirium in hospitalized non-ICU patients: A Cochrane review summary. Int J Nurs Stud. 2017 May;70:142-143. doi: 10.1016/j.ijnurstu.2016.11.010. Epub 2016 Nov 17. No abstract available.</citation>
    <PMID>28160968</PMID>
  </reference>
  <reference>
    <citation>Liu C, Zhang Y, She S, Xu L, Ruan X. A randomised controlled trial of dexmedetomidine for suspension laryngoscopy. Anaesthesia. 2013 Jan;68(1):60-6. doi: 10.1111/j.1365-2044.2012.07331.x. Epub 2012 Oct 29.</citation>
    <PMID>23106186</PMID>
  </reference>
  <reference>
    <citation>Gozalo-Marcilla M, Hopster K, Gasthuys F, Hatz L, Krajewski AE, Schauvliege S. Effects of a constant-rate infusion of dexmedetomidine on the minimal alveolar concentration of sevoflurane in ponies. Equine Vet J. 2013 Mar;45(2):204-8. doi: 10.1111/j.2042-3306.2012.00613.x. Epub 2012 Aug 1.</citation>
    <PMID>22853551</PMID>
  </reference>
  <reference>
    <citation>Bekker A, Haile M, Kline R, Didehvar S, Babu R, Martiniuk F, Urban M. The effect of intraoperative infusion of dexmedetomidine on the quality of recovery after major spinal surgery. J Neurosurg Anesthesiol. 2013 Jan;25(1):16-24. doi: 10.1097/ANA.0b013e31826318af.</citation>
    <PMID>22824921</PMID>
  </reference>
  <reference>
    <citation>Shim JJ, Leung JM. An update on delirium in the postoperative setting: prevention, diagnosis and management. Best Pract Res Clin Anaesthesiol. 2012 Sep;26(3):327-43. doi: 10.1016/j.bpa.2012.08.003.</citation>
    <PMID>23040284</PMID>
  </reference>
  <reference>
    <citation>Park JK, Cheong SH, Lee KM, Lim SH, Lee JH, Cho K, Kim MH, Kim HT. Does dexmedetomidine reduce postoperative pain after laparoscopic cholecystectomy with multimodal analgesia? Korean J Anesthesiol. 2012 Nov;63(5):436-40. doi: 10.4097/kjae.2012.63.5.436. Epub 2012 Nov 16.</citation>
    <PMID>23198038</PMID>
  </reference>
  <reference>
    <citation>Anger KE. Dexmedetomidine: a review of its use for the management of pain, agitation, and delirium in the intensive care unit. Curr Pharm Des. 2013;19(22):4003-13. doi: 10.2174/1381612811319220009.</citation>
    <PMID>23228319</PMID>
  </reference>
  <reference>
    <citation>Ji F, Li Z, Nguyen H, Young N, Shi P, Fleming N, Liu H. Response to letters regarding article, &quot;perioperative dexmedetomidine improves outcomes of cardiac surgery&quot;. Circulation. 2013 Oct 15;128(16):e339-40. doi: 10.1161/CIRCULATIONAHA.113.005450. No abstract available.</citation>
    <PMID>24126331</PMID>
  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>March 7, 2022</last_update_submitted>
  <last_update_submitted_qc>March 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2022</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>Cardiac surgery</keyword>
  <keyword>Dexmedetomidine</keyword>
  <keyword>Long-term outcome</keyword>
  <keyword>Mortality</keyword>
  <keyword>Quality of life</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>


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/NCT03289325
org study id: 2016-1188
nct id: NCT03289325
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A retrospective study showed that intraoperative dexmedetomidine administration was
      associated with decreased risk of 1-year mortality after cardiac surgery. In a previous
      randomized controlled trial, 285 elderly patients undergoing cardiac surgery were randomized
      to receive either perioperative dexmedetomidine or placebo (normal saline) administration.
      The purpose of this 6-year follow-up study is to investigate whether perioperative
      dexmedetomidine can improve long-term outcomes in those recruited elderly patients after
      cardiac surgery.
Dexmedetomidine is a highly selective alpha 2-adrenergic receptor agonist that provides
      anti-anxiety, sedation, and modest analgesic effects. In a retrospective cohort study of
      patients undergoing cardiac surgery, perioperative dexmedetomidine administration was
      associated with decreased risk of 1-year mortality. Theoretically, perioperative
      dexmedetomidine may exert the following favorable for cardiac surgery patients: (1) reduces
      perioperative opioid consumption and thereby mitigates opioid-induced immunosuppression, (2)
      dampens hyper-inflammatory response induced by surgery, and (3) improves postoperative sleep
      quality. However, prospective studies investigating the long-term effects of perioperative
      dexmedetomidine in cardiac surgery patients are still lacking.

      In a previous randomized controlled trial, 285 patients of 60 years or older who were
      scheduled to undergo coronary artery bypass graft surgery and/or valve replacement surgery
      were randomized to receive either perioperative dexmedetomidine administration (0.6
      microgram/kg in 10 minutes before anesthesia induction, followed by a continuous infusion at
      a rate of 0.4 microgram/kg/h until the end of surgery, then a continuous infusion at a rate
      of 0.1 microgram/kg/h until the end of mechanical ventilation) or placebo (normal saline,
      administered in the same rate or volume for the same duration as in the dexmedetomidine
      group). The results showed that perioperative dexmedetomidine reduced the incidence of
      pulmonary complications and shortened the duration of mechanical ventilation after surgery.

      The purpose of this 6-year follow-up study is to investigate the effects of perioperative
      dexmedetomidine on the long-term outcomes in elderly patients after cardiac 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 6 years after surgery
description: Overall survival after surgery
measure: Major adverse cardiovascular events-free survival after surgery
time frame: Up to 6 years after surgery
description: Major adverse cardiovascular events include cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and myocardial revascularization.
measure: Hospital-free survival after surgery
time frame: Up to 6 years after surgery
description: Event indicates any medical condition that lead to hospitalization after surgery.
measure: Cognitive function in 6-year survivors after surgery
time frame: At the 6th year after surgery
description: Cognitive function is assessed with Telephone Interview for Cognitive Status-Modified (TICS-M; scores range from 0 to 50, with higher score indicating better cognitive function).
measure: Health related quality of life in 6-year survivors after surgery
time frame: At the 6th year after surgery
description: Health related quality of life is assessed with the short-form 36-item health survey questionnaire (SF-36). The SF-36 scale measures eight aspects of health status, i.e., physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. It also measures changes of subjective healthy status during the last year (reported health transition). The scores of the above 9 items are calculated separately with scores range from 0 to 100, with higher score indicating better quality.
arm group label: DEX group
arm group type: Experimental
description: The active drug (dexmedetomidine hydrochloride for injection) will be administered during a period from before anesthesia induction until the end of mechanical ventilation after surgery.
arm group label: CTRL group
arm group type: Placebo Comparator
description: The placebo drug (normal saline, or 0.9% sodium chloride for injection) will be administered in the same rate and volume for a same duration as that in the DEX group.
intervention type: Drug
intervention name: dexmedetomidine hydrochloride for injection
description: Before anesthesia, dexmedetomidine hydrochloride for injection (200 ug/2 ml) will be diluted with normal saline to 50 ml (final dexmedetomidine concentration 4 ug/ml).
Before anesthesia induction, a loading dose will be administered by intravenous infusion at a rate of [0.9*kg] ml/h for 10 minutes (i.e., dexmedetomidine 0.6 ug/kg in 10 minutes), followed by continuous infusion at a rate of [0.1*kg] ml/h (i.e., dexmedetomidine at a rate of 0.4 ug/kg/h) until the end of surgery.
After surgery, the infusion rate will be decreased to [0.025*kg] ml/h (i.e., dexmedetomidine at a rate of 0.1 ug/kg/h) and continued until the end of mechanical ventilation.
arm group label: DEX group
other name: Aibeining (trade name)
intervention type: Drug
intervention name: 0.9% sodium chloride for injection
description: Before anesthesia, 0.9% sodium chloride for injection 50 ml will be prepared.
Before anesthesia induction, a loading dose will be administered by intravenous infusion at a rate of [0.9*kg] ml/h for 10 minutes, followed by continuous infusion at a rate of [0.1*kg] ml/h until the end of surgery.
After surgery, the infusion rate will be decreased to [0.025*kg] ml/h and continued until the end of mechanical ventilation.
arm group label: CTRL 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
facility: 
country: China
citation: Guenther U, Radtke FM. Delirium in the postanaesthesia period. Curr Opin Anaesthesiol. 2011 Dec;24(6):670-5. doi: 10.1097/ACO.0b013e32834c7b44.
PMID: 21971396
citation: Morandi A, Pandharipande PP, Jackson JC, Bellelli G, Trabucchi M, Ely EW. Understanding terminology of delirium and long-term cognitive impairment in critically ill patients. Best Pract Res Clin Anaesthesiol. 2012 Sep;26(3):267-76. doi: 10.1016/j.bpa.2012.08.001.
PMID: 23040280
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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: Dexmedetomidine
sharing ipd: No