<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/NCT04488952</url>
  </required_header>
  <id_info>
    <org_study_id>20193357001-XZ01</org_study_id>
    <nct_id>NCT04488952</nct_id>
  </id_info>
  <brief_title>The Effects of Different Anesthesia Methods on Perioperative Neurocognitive Disorders in the Elderly</brief_title>
  <official_title>The Effects of Different Anesthesia Methods on Perioperative Neurocognitive Disorders in the Elderly: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shenzhen Second People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shenzhen Second People's Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      Perioperative Neurocognitive Disorders(PND) is a common perioperative complication among the&#xD;
      elderly, especially in the plastic surgery. Different anesthesia methods have different&#xD;
      incidences of PND, but it's still unknow which is better between spinal anesthesia and nerve&#xD;
      block combined with general anesthesia. We will apply a psychometric battery test which&#xD;
      contain different cognitive domains to estimate the incidence of PND at a week a month and a&#xD;
      year after surgery with different anesthesia methods. Study has showed that functional&#xD;
      magnetic resonance imaging (fMRI) could detect a cognitive decline through spontaneous&#xD;
      neuronal activity in the cortex and hippocampus. In our study, multi-mode imaging technology&#xD;
      is used to conduct in-depth research on MRI and make correlation analysis with cognitive&#xD;
      function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 8, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of PND seven days after surgery</measure>
    <time_frame>seven days after surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of PND one month after surgery</measure>
    <time_frame>one month after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of PND one year after surgery</measure>
    <time_frame>one year after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital stay</measure>
    <time_frame>one to two weeks after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients entrance the ward of ICU after surgery</measure>
    <time_frame>one week post-operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality rate</measure>
    <time_frame>one year after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative complications</measure>
    <time_frame>one month post-operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ADL of frontal lobe，temporal lobe and occipital lobe</measure>
    <time_frame>one day pre-operation, one week post-operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ADL of frontal lobe</measure>
    <time_frame>one day pre-operation, one week post-operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BOLD of the whole brain</measure>
    <time_frame>one day pre-operation, one week post-operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ADL of temporal lobe</measure>
    <time_frame>one day pre-operation, one week post-operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ADL of occipital lobe</measure>
    <time_frame>one day pre-operation, one week post-operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>One year event-free survival</measure>
    <time_frame>one year after surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">350</enrollment>
  <condition>PND</condition>
  <arm_group>
    <arm_group_label>nerve block combined with general anesthesia group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this group receive nerve block combined with general anesthesia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>spinal anesthesia group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this group receive spinal anesthesia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This group is used to obtain the learning effect.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>nerve block combined with general anesthesia</intervention_name>
    <description>Patients in this group receive nerve block combined with general anesthesia.</description>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>nerve block combined with general anesthesia group</arm_group_label>
    <arm_group_label>spinal anesthesia group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>spinal anesthesia</intervention_name>
    <description>Patients in this group receive spinal anesthesia.</description>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>nerve block combined with general anesthesia group</arm_group_label>
    <arm_group_label>spinal anesthesia group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged 60-85years&#xD;
&#xD;
          -  ASA I-III&#xD;
&#xD;
          -  Received elective surgery of unilateral lower extremity orthopedics&#xD;
&#xD;
          -  The anesthesia lasted more than 2 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Zhiheng Liu, MD</last_name>
    <phone>+86-0755-83366388</phone>
    <email>15818585570@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nanbo Luo, MD</last_name>
    <phone>+86-0755-83366388</phone>
    <email>316916645@qq.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Shenzhen Second People's Hospital</name>
      <address>
        <city>Shenzhen</city>
        <state>Guangdong</state>
        <zip>518035</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nanbo Luo, MD</last_name>
      <phone>+8615112389303</phone>
      <email>316916645@qq.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Bittner EA, Yue Y, Xie Z. Brief review: anesthetic neurotoxicity in the elderly, cognitive dysfunction and Alzheimer's disease. Can J Anaesth. 2011 Feb;58(2):216-23. doi: 10.1007/s12630-010-9418-x. Epub 2010 Dec 21.</citation>
    <PMID>21174183</PMID>
  </reference>
  <reference>
    <citation>Yildizeli B, Ozyurtkan MO, Batirel HF, Kuscu K, Bekiroglu N, Yuksel M. Factors associated with postoperative delirium after thoracic surgery. Ann Thorac Surg. 2005 Mar;79(3):1004-9. doi: 10.1016/j.athoracsur.2004.06.022.</citation>
    <PMID>15734423</PMID>
  </reference>
  <reference>
    <citation>Mason SE, Noel-Storr A, Ritchie CW. The impact of general and regional anesthesia on the incidence of post-operative cognitive dysfunction and post-operative delirium: a systematic review with meta-analysis. J Alzheimers Dis. 2010;22 Suppl 3:67-79. doi: 10.3233/JAD-2010-101086.</citation>
    <PMID>20858956</PMID>
  </reference>
  <reference>
    <citation>Alkire MT, Pomfrett CJ, Haier RJ, Gianzero MV, Chan CM, Jacobsen BP, Fallon JH. Functional brain imaging during anesthesia in humans: effects of halothane on global and regional cerebral glucose metabolism. Anesthesiology. 1999 Mar;90(3):701-9. doi: 10.1097/00000542-199903000-00011.</citation>
    <PMID>10078670</PMID>
  </reference>
  <reference>
    <citation>Peng L, Xu L, Ouyang W. Role of peripheral inflammatory markers in postoperative cognitive dysfunction (POCD): a meta-analysis. PLoS One. 2013 Nov 13;8(11):e79624. doi: 10.1371/journal.pone.0079624. eCollection 2013.</citation>
    <PMID>24236147</PMID>
  </reference>
  <reference>
    <citation>Silbert B, Evered L, Scott DA, McMahon S, Choong P, Ames D, Maruff P, Jamrozik K. Preexisting cognitive impairment is associated with postoperative cognitive dysfunction after hip joint replacement surgery. Anesthesiology. 2015 Jun;122(6):1224-34. doi: 10.1097/ALN.0000000000000671.</citation>
    <PMID>25859906</PMID>
  </reference>
  <reference>
    <citation>Squire LR. Memory and the hippocampus: a synthesis from findings with rats, monkeys, and humans. Psychol Rev. 1992 Apr;99(2):195-231. doi: 10.1037/0033-295x.99.2.195. Erratum In: Psychol Rev 1992 Jul;99(3):582.</citation>
    <PMID>1594723</PMID>
  </reference>
  <reference>
    <citation>Zola-Morgan S, Squire LR, Amaral DG. Human amnesia and the medial temporal region: enduring memory impairment following a bilateral lesion limited to field CA1 of the hippocampus. J Neurosci. 1986 Oct;6(10):2950-67. doi: 10.1523/JNEUROSCI.06-10-02950.1986.</citation>
    <PMID>3760943</PMID>
  </reference>
  <reference>
    <citation>Price CC, Tanner JJ, Schmalfuss I, Garvan CW, Gearen P, Dickey D, Heilman K, McDonagh DL, Libon DJ, Leonard C, Bowers D, Monk TG. A pilot study evaluating presurgery neuroanatomical biomarkers for postoperative cognitive decline after total knee arthroplasty in older adults. Anesthesiology. 2014 Mar;120(3):601-13. doi: 10.1097/ALN.0000000000000080.</citation>
    <PMID>24534857</PMID>
  </reference>
  <reference>
    <citation>Hole A, Terjesen T, Breivik H. Epidural versus general anaesthesia for total hip arthroplasty in elderly patients. Acta Anaesthesiol Scand. 1980 Aug;24(4):279-87. doi: 10.1111/j.1399-6576.1980.tb01549.x.</citation>
    <PMID>7468115</PMID>
  </reference>
  <reference>
    <citation>Berggren D, Gustafson Y, Eriksson B, Bucht G, Hansson LI, Reiz S, Winblad B. Postoperative confusion after anesthesia in elderly patients with femoral neck fractures. Anesth Analg. 1987 Jun;66(6):497-504.</citation>
    <PMID>3578861</PMID>
  </reference>
  <reference>
    <citation>Williams-Russo P, Sharrock NE, Mattis S, Szatrowski TP, Charlson ME. Cognitive effects after epidural vs general anesthesia in older adults. A randomized trial. JAMA. 1995 Jul 5;274(1):44-50.</citation>
    <PMID>7791257</PMID>
  </reference>
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    <citation>Moller JT, Cluitmans P, Rasmussen LS, Houx P, Rasmussen H, Canet J, Rabbitt P, Jolles J, Larsen K, Hanning CD, Langeron O, Johnson T, Lauven PM, Kristensen PA, Biedler A, van Beem H, Fraidakis O, Silverstein JH, Beneken JE, Gravenstein JS. Long-term postoperative cognitive dysfunction in the elderly ISPOCD1 study. ISPOCD investigators. International Study of Post-Operative Cognitive Dysfunction. Lancet. 1998 Mar 21;351(9106):857-61. doi: 10.1016/s0140-6736(97)07382-0. Erratum In: Lancet 1998 Jun 6;351(9117):1742.</citation>
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    <PMID>12648190</PMID>
  </reference>
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    <citation>O'Hara DA, Duff A, Berlin JA, Poses RM, Lawrence VA, Huber EC, Noveck H, Strom BL, Carson JL. The effect of anesthetic technique on postoperative outcomes in hip fracture repair. Anesthesiology. 2000 Apr;92(4):947-57. doi: 10.1097/00000542-200004000-00011.</citation>
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    <citation>Shi J, Tian J, Wei M, Miao Y, Wang Y. The utility of the Hopkins Verbal Learning Test (Chinese version) for screening dementia and mild cognitive impairment in a Chinese population. BMC Neurol. 2012 Nov 7;12:136. doi: 10.1186/1471-2377-12-136.</citation>
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    <citation>Norkiene I, Samalavicius R, Ivaskevicius J, Budrys V, Paulauskiene K. Asymptomatic carotid artery stenosis and cognitive outcomes after coronary artery bypass grafting. Scand Cardiovasc J. 2011 Jun;45(3):169-73. doi: 10.3109/14017431.2011.562525. Epub 2011 Mar 15.</citation>
    <PMID>21405959</PMID>
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    <citation>Knopman DS, Roberts RO, Geda YE, Pankratz VS, Christianson TJ, Petersen RC, Rocca WA. Validation of the telephone interview for cognitive status-modified in subjects with normal cognition, mild cognitive impairment, or dementia. Neuroepidemiology. 2010;34(1):34-42. doi: 10.1159/000255464. Epub 2009 Nov 5.</citation>
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    <citation>Evered L, Silbert B, Knopman DS, Scott DA, DeKosky ST, Rasmussen LS, Oh ES, Crosby G, Berger M, Eckenhoff RG; Nomenclature Consensus Working Group. Recommendations for the nomenclature of cognitive change associated with anaesthesia and surgery-2018. Br J Anaesth. 2018 Nov;121(5):1005-1012. doi: 10.1016/j.bja.2017.11.087. Epub 2018 Jun 15.</citation>
    <PMID>30336844</PMID>
  </reference>
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    <citation>Li WX, Luo RY, Chen C, Li X, Ao JS, Liu Y, Yin YQ. Effects of propofol, dexmedetomidine, and midazolam on postoperative cognitive dysfunction in elderly patients: a randomized controlled preliminary trial. Chin Med J (Engl). 2019 Feb;132(4):437-445. doi: 10.1097/CM9.0000000000000098.</citation>
    <PMID>30707179</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>April 26, 2022</last_update_submitted>
  <last_update_submitted_qc>April 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shenzhen Second People's Hospital</investigator_affiliation>
    <investigator_full_name>ZhiHeng Liu</investigator_full_name>
    <investigator_title>Chair of Department of Anesthesiology</investigator_title>
  </responsible_party>
  <keyword>PND,anesthesia method, elderly</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neurocognitive Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</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/NCT04488952
org study id: 20193357001-XZ01
nct id: NCT04488952
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Perioperative Neurocognitive Disorders(PND) is a common perioperative complication among the
      elderly, especially in the plastic surgery. Different anesthesia methods have different
      incidences of PND, but it's still unknow which is better between spinal anesthesia and nerve
      block combined with general anesthesia. We will apply a psychometric battery test which
      contain different cognitive domains to estimate the incidence of PND at a week a month and a
      year after surgery with different anesthesia methods. Study has showed that functional
      magnetic resonance imaging (fMRI) could detect a cognitive decline through spontaneous
      neuronal activity in the cortex and hippocampus. In our study, multi-mode imaging technology
      is used to conduct in-depth research on MRI and make correlation analysis with cognitive
      function.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence of PND seven days after surgery
time frame: seven days after surgery
measure: Incidence of PND one month after surgery
time frame: one month after surgery
measure: Incidence of PND one year after surgery
time frame: one year after surgery
measure: Hospital stay
time frame: one to two weeks after surgery
measure: Number of patients entrance the ward of ICU after surgery
time frame: one week post-operation
measure: Mortality rate
time frame: one year after surgery
measure: Postoperative complications
time frame: one month post-operation
measure: ADL of frontal lobe，temporal lobe and occipital lobe
time frame: one day pre-operation, one week post-operation
measure: ADL of frontal lobe
time frame: one day pre-operation, one week post-operation
measure: BOLD of the whole brain
time frame: one day pre-operation, one week post-operation
measure: ADL of temporal lobe
time frame: one day pre-operation, one week post-operation
measure: ADL of occipital lobe
time frame: one day pre-operation, one week post-operation
measure: One year event-free survival
time frame: one year after surgery
arm group label: nerve block combined with general anesthesia group
arm group type: Experimental
description: Patients in this group receive nerve block combined with general anesthesia.
arm group label: spinal anesthesia group
arm group type: Experimental
description: Patients in this group receive spinal anesthesia.
arm group label: control group
arm group type: Placebo Comparator
description: This group is used to obtain the learning effect.
intervention type: Device
intervention name: nerve block combined with general anesthesia
description: Patients in this group receive nerve block combined with general anesthesia.
arm group label: control group
arm group label: nerve block combined with general anesthesia group
arm group label: spinal anesthesia group
intervention type: Device
intervention name: spinal anesthesia
description: Patients in this group receive spinal anesthesia.
arm group label: control group
arm group label: nerve block combined with general anesthesia group
arm group label: spinal anesthesia group
criteria: 
gender: All
minimum age: 60 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Zhiheng Liu, MD
phone: +86-0755-83366388
email: 15818585570@163.com
last name: Nanbo Luo, MD
phone: +86-0755-83366388
email: 316916645@qq.com
facility: 
status: Recruiting
contact: 
country: China
citation: Bittner EA, Yue Y, Xie Z. Brief review: anesthetic neurotoxicity in the elderly, cognitive dysfunction and Alzheimer's disease. Can J Anaesth. 2011 Feb;58(2):216-23. doi: 10.1007/s12630-010-9418-x. Epub 2010 Dec 21.
PMID: 21174183
citation: Yildizeli B, Ozyurtkan MO, Batirel HF, Kuscu K, Bekiroglu N, Yuksel M. Factors associated with postoperative delirium after thoracic surgery. Ann Thorac Surg. 2005 Mar;79(3):1004-9. doi: 10.1016/j.athoracsur.2004.06.022.
PMID: 15734423
citation: Mason SE, Noel-Storr A, Ritchie CW. The impact of general and regional anesthesia on the incidence of post-operative cognitive dysfunction and post-operative delirium: a systematic review with meta-analysis. J Alzheimers Dis. 2010;22 Suppl 3:67-79. doi: 10.3233/JAD-2010-101086.
PMID: 20858956
citation: Alkire MT, Pomfrett CJ, Haier RJ, Gianzero MV, Chan CM, Jacobsen BP, Fallon JH. Functional brain imaging during anesthesia in humans: effects of halothane on global and regional cerebral glucose metabolism. Anesthesiology. 1999 Mar;90(3):701-9. doi: 10.1097/00000542-199903000-00011.
PMID: 10078670
citation: Peng L, Xu L, Ouyang W. Role of peripheral inflammatory markers in postoperative cognitive dysfunction (POCD): a meta-analysis. PLoS One. 2013 Nov 13;8(11):e79624. doi: 10.1371/journal.pone.0079624. eCollection 2013.
PMID: 24236147
citation: Silbert B, Evered L, Scott DA, McMahon S, Choong P, Ames D, Maruff P, Jamrozik K. Preexisting cognitive impairment is associated with postoperative cognitive dysfunction after hip joint replacement surgery. Anesthesiology. 2015 Jun;122(6):1224-34. doi: 10.1097/ALN.0000000000000671.
PMID: 25859906
citation: Squire LR. Memory and the hippocampus: a synthesis from findings with rats, monkeys, and humans. Psychol Rev. 1992 Apr;99(2):195-231. doi: 10.1037/0033-295x.99.2.195. Erratum In: Psychol Rev 1992 Jul;99(3):582.
PMID: 1594723
citation: Zola-Morgan S, Squire LR, Amaral DG. Human amnesia and the medial temporal region: enduring memory impairment following a bilateral lesion limited to field CA1 of the hippocampus. J Neurosci. 1986 Oct;6(10):2950-67. doi: 10.1523/JNEUROSCI.06-10-02950.1986.
PMID: 3760943
citation: Price CC, Tanner JJ, Schmalfuss I, Garvan CW, Gearen P, Dickey D, Heilman K, McDonagh DL, Libon DJ, Leonard C, Bowers D, Monk TG. A pilot study evaluating presurgery neuroanatomical biomarkers for postoperative cognitive decline after total knee arthroplasty in older adults. Anesthesiology. 2014 Mar;120(3):601-13. doi: 10.1097/ALN.0000000000000080.
PMID: 24534857
citation: Hole A, Terjesen T, Breivik H. Epidural versus general anaesthesia for total hip arthroplasty in elderly patients. Acta Anaesthesiol Scand. 1980 Aug;24(4):279-87. doi: 10.1111/j.1399-6576.1980.tb01549.x.
PMID: 7468115
citation: Berggren D, Gustafson Y, Eriksson B, Bucht G, Hansson LI, Reiz S, Winblad B. Postoperative confusion after anesthesia in elderly patients with femoral neck fractures. Anesth Analg. 1987 Jun;66(6):497-504.
PMID: 3578861
citation: Williams-Russo P, Sharrock NE, Mattis S, Szatrowski TP, Charlson ME. Cognitive effects after epidural vs general anesthesia in older adults. A randomized trial. JAMA. 1995 Jul 5;274(1):44-50.
PMID: 7791257
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responsible party type: Principal Investigator
investigator affiliation: Shenzhen Second People's Hospital
investigator full name: ZhiHeng Liu
investigator title: Chair of Department of Anesthesiology
mesh term: Neurocognitive Disorders
mesh term: Anesthetics
sharing ipd: No