<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/NCT02213380</url>
  </required_header>
  <id_info>
    <org_study_id>RAGA-Delirium</org_study_id>
    <nct_id>NCT02213380</nct_id>
  </id_info>
  <brief_title>Effect of Anesthesia on Post-operative Delirium in Elderly Patients Undergoing Hip Fracture Surgery</brief_title>
  <acronym>RAGADelirium</acronym>
  <official_title>Effect of Regional Anaesthesia and General Anaesthesia on Postoperative Delirium in Elderly Patients Undergoing Hip Fracture Surgery: a Multicenter Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wenzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Research Institute for Family Planning, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Wenzhou Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is evaluate postoperative delirium after general anesthesia and&#xD;
      regional anesthesia in elderly patients undergoing hip fracture surgery. Our research&#xD;
      hypotheses are: (1) regional anesthesia may contribute to decrease the incidence of&#xD;
      postoperative delirium. (2) Regional anesthesia may improve the outcome of elderly patient&#xD;
      and reduce healthcare costs associated with postoperative delirium. (3) Postoperative&#xD;
      delirium may result in poor long-term functional outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperative delirium (POD) is an acute confusional state associated with changes in&#xD;
      consciousness, arousal level and cognitive status. Elderly patients with hip fractures have&#xD;
      the high incidence of delirium. The high risk factor of delirium include: Age 65 years or&#xD;
      older, cognitive impairment/dementia, current hip fracture, severe illness and so on. Many&#xD;
      previous studies predict that the majority of general anesthetic and sedative agents can&#xD;
      favour postoperative delirium. However, none of studies have investigated the effect of&#xD;
      general anesthesia and the effect of regional anesthesia and general anesthesia on the&#xD;
      postoperative delirium in elderly patients undergoing hip fracture surgery in China. This&#xD;
      multicentre, prospective, randomized controlled clinical trial is designed to evaluate&#xD;
      postoperative delirium after general anesthesia and regional anesthesia in elderly patients&#xD;
      undergoing hip fracture surgery. Our research hypotheses are: (1) regional anesthesia may&#xD;
      contribute to decrease the incidence of postoperative delirium. (2) Regional anesthesia may&#xD;
      improve the outcome of elderly patient and reduce healthcare costs associated with&#xD;
      postoperative delirium. (3) Postoperative delirium may result in poor long-term functional&#xD;
      outcomes.&#xD;
&#xD;
      This trial has the following nine investigational centers: Department of Anesthesiology, The&#xD;
      Second Affiliated Hospital &amp; Yuying Children hospital of Wenzhou Medical University, Wenzhou,&#xD;
      China; Department of Anesthesiology, Tongji Hospital, Tongji Medical college, Huazhong&#xD;
      University of Science &amp; Technology, Wuhan, China; Department of Anesthesiology, West China&#xD;
      Hospital of Sichuan University, Chengdu, China; Department of Anesthesiology, Southwest&#xD;
      Hospital, Chongqing, China; Department of Anesthesiology, The Second Affiliated Hospital of&#xD;
      Zhejiang University School of Medicine, Hangzhou, China; Department of Anesthesiology,&#xD;
      Beijing Jishuitan Hospital, Beijing, China; Department of Anesthesiology, The First&#xD;
      Affiliated Hospital of Nanchang University, Nanchang, China; Department of Anesthesiology,&#xD;
      The Second Hospital of Anhui Medical University, Anhui, China; The First Affiliated Hospital&#xD;
      of Wenzhou Medical University, Wenzhou, China;&#xD;
&#xD;
      Eligible patients will be assigned into two study groups (group RA: regional anesthesia will&#xD;
      be used, group GA: General anesthesia will be used) by centre-minimization randomization (web&#xD;
      or telephone). There are 3 stratification factors: age (65-79,≥80), presence of delirium(yes,&#xD;
      no), dementia(yes, no). There will be two teams of investigators involved in trial procedure&#xD;
      and the patient's follow-up. Investigator A (experienced anesthetist), who are competent in&#xD;
      caring for patients undergoing hip fracture surgery, will perform following works, which&#xD;
      includes informed consent, randomization, anesthesia and recovery parameters. Investigator B&#xD;
      will visit patient the day before surgery and 7days after surgery or until discharge to&#xD;
      assess patient for presence, type and severity of delirium, collect other data during in&#xD;
      hospital stay and follow up patients at 6 and 12 months. Investigator B will receive uniform&#xD;
      training of using of CAM, Delirium Rating Scale-Revised-98 (DRS-R-98), MMSE and other test&#xD;
      used in this trial) and will be not clear about protocol.&#xD;
&#xD;
      Within 24 h before surgery, cognitive function of each patient will be assessed with the&#xD;
      MMSE, the presence of delirium will be diagnosed with the CAM, the type and severity of&#xD;
      delirium will be assessed with DRS-R-98 and the pain will be assessed with a 100-mm visual&#xD;
      analog scale (VAS). Routine monitoring (NBP, continuous ECG, and pulse oximetry) was&#xD;
      initiated on all patients. Premedication for anesthesia will be avoided before surgery. Any&#xD;
      medication impairing cognitive function will not be recommended, if administered, must be&#xD;
      recorded it in detail.&#xD;
&#xD;
      Investigator A will allocated the patient into group GA or group RA according the&#xD;
      centre-randomization with a unique registration number for each eligible patient. Treatment&#xD;
      protocols for both groups will also stipulate no sedative be administrated during operation.&#xD;
      Routine monitoring was initiated on all patients. Hypotension (Systolic Blood Pressure&lt;90mmHg&#xD;
      or drop of Mean Arterial Pressure&gt;30%) should be treated with vasoactive agents or fluid&#xD;
      boluses as deemed appropriate by anesthetists.&#xD;
&#xD;
      Postoperative analgesia will be administered according to the local procedures of each&#xD;
      clinical trial site, aiming to maintain a VAS pain score ≤ 30 mm. Both groups will receive&#xD;
      routine postoperative care on orthopedic ward.&#xD;
&#xD;
      All randomized patients will be followed up to 7 days after surgery (or discharge from the&#xD;
      hospital). The 7 days follow-up includes: CAM, DRS-98-R (if applicable), VAS, Analgesic use&#xD;
      (if applicable), Sedative use (if applicable), Post-operative morbidity and laboratory&#xD;
      results (including serum hemoglobin, hematocrit, leucocytes, aspartate aminotransferase&#xD;
      (AST), alanine aminotransferase (ALT), albumin, serum creatinine and urea concentrations,&#xD;
      serum sodium and potassium and serum glucose concentration). Concomitant medications, adverse&#xD;
      events and serious adverse events are record in all study visits. Economic parameters&#xD;
      include: time to be discharged from post operation, total cost in hospital and cost for&#xD;
      anesthesia of patient. Investigator B will also assess patient with POD in clinic or at their&#xD;
      residence at 6 and 12 months to assess for presence of delirium, its type and severity (CAM,&#xD;
      DRS-98-R), cognitive function using MMSE, and quality of life using The MOS 36-item&#xD;
      Short-Form Health Survey (SF-36) questionnaire.&#xD;
&#xD;
      The study will be monitored regularly by the clinical research associate (CRA) through visits&#xD;
      or telephone. CRA will verify the consistency of the data recorded on the case report forms&#xD;
      with the source documents and the management of therapeutic batches, the presence and&#xD;
      completeness of the investigator file.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">January 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</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>Single (Outcomes Assessor)</masking>
    <masking_description>Data collectors or outcome assessors, e.g. the medical staff who provide post-operative care in the ward and visit patients for preoperational assessment, hospital visits and subsequent follow-ups, will be blinded from group allocation throughout the study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Post-operative Delirium in 7 Days Post Operation</measure>
    <time_frame>in 7 days post operation</time_frame>
    <description>Post-operative delirium diagnosed with Confusion Assessment Method</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Post-operative Delirium</measure>
    <time_frame>within fist 7days post operation</time_frame>
    <description>Number of participants with delirium includes patients who had delirium in the post in the first 7 post-operative days.&#xD;
The severity of delirium was described using a severity score from 0 (no delirium) to 39 (highest severity) and subtypes of delirium as hyperactive, hypoactive or mixed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of Delirium</measure>
    <time_frame>within first 7days post operation</time_frame>
    <description>The worst severity scores of delirium was diagnosed with the DRS-R-98 within 7 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Subtypes of Delirium Diagnosed in 7 Days Post Operation</measure>
    <time_frame>within first 7 days post operation</time_frame>
    <description>The subtypes of delirium diagnosed with the Delirium Rating Scale-Revised-98 (DRS-R-98).&#xD;
Patients with the hyperactive subtype may be agitated, disoriented, and delusional, and may experience hallucinations. This presentation can be confused with that of schizophrenia, agitated dementia, or a psychotic disorder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30 Day Mortality</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>Mortality within 30 days post operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute Pain Score Using Visual Analogue Scale (VAS)</measure>
    <time_frame>In 7days post operation</time_frame>
    <description>The worst pain score within 7 days post-operation in both groups. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between no pain(0 point) to worst pain (100 points).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Hospital Stay</measure>
    <time_frame>till the day of discharge from hospital, an average of 7 days</time_frame>
    <description>Length of hospital stay are measured from the anesthesia starting day to the discharge day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Costs of Anesthetic Procedure</measure>
    <time_frame>1 day after operation</time_frame>
    <description>Costs of anesthetic procedure only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total In-hospital Costs</measure>
    <time_frame>till the day of discharge</time_frame>
    <description>Entire expenditure in-hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6 Months Incidence of Delirium</measure>
    <time_frame>6 months after discharge</time_frame>
    <description>in clinic or at their residence, diagnosed with Confusion Assessment Method (CAM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>12 Months Incidence of Delirium</measure>
    <time_frame>12 months after discharge</time_frame>
    <description>in clinic or at their residence, diagnosed with Confusion Assessment Method (CAM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6 Months Quality of Life</measure>
    <time_frame>6 months after discharge</time_frame>
    <description>using 36-Item Short Form Survey (SF-36) questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>12 Months Quality of Life</measure>
    <time_frame>12months after discharge</time_frame>
    <description>using 36-Item Short Form Survey (SF-36) questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">950</enrollment>
  <condition>Post Operative Delirium</condition>
  <arm_group>
    <arm_group_label>group GA</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>General anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group RA</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Regional anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>method of anesthesia</intervention_name>
    <description>General anesthesia and regional anesthesia.&#xD;
General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.&#xD;
Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA</description>
    <arm_group_label>group GA</arm_group_label>
    <arm_group_label>group RA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  older patient (≥65 years)&#xD;
&#xD;
          -  patient with hip fracture and planned hip fracture surgery&#xD;
&#xD;
          -  patient willing to complete this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient with multiple trauma or multiple fractures, pathological fractures, pelvic&#xD;
             fractures, femur fractures&#xD;
&#xD;
          -  contraindication (serious illness or medical conditions) for general anesthesia&#xD;
&#xD;
          -  contraindication (infection at the site of needle insertion, coagulopathy,&#xD;
             international normalized ratio &gt;1.4, platelet count &lt;80×109 litre-1, allergy to local&#xD;
             anaesthetics and so on) for regional anesthesia;&#xD;
&#xD;
          -  patient who cannot complete the preoperative mental tests (CAM and/or Mini-Mental&#xD;
             State Examination (MMSE)) of this clinical trial&#xD;
&#xD;
          -  patient known to susceptible to malignant hyperthermia&#xD;
&#xD;
          -  known allergy or hypersensitivity to any drugs administered during this clinical trial&#xD;
&#xD;
          -  previous participation in this clinical trial&#xD;
&#xD;
          -  participation in another clinical trial within 4 weeks prior to selection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fang Gao, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>The Second Affiliated Hospital &amp; Yuying Children hospital of Wenzhou Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Qingquan Lian, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>The Second Affiliated Hospital &amp; Yuying Children hospital of Wenzhou Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jun Li, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>The Second Affiliated Hospital &amp; Yuying Children hospital of Wenzhou Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ting Li, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Second Affiliated Hospital &amp; Yuying Children hospital of Wenzhou Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joice Yeung, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Heart of England NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Teresa Moledy</last_name>
    <role>Study Director</role>
    <affiliation>Heart of England NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Second Hospital of Anhui Medical University</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230601</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tongji Hospital, Tongji Medical college</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Nanchang University</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <zip>330006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West China Hospital of Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The People's Hospital of Lishi</name>
      <address>
        <city>Lishi</city>
        <state>Zhejiang</state>
        <zip>323000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Central Hospital of Lishui City</name>
      <address>
        <city>Lishui</city>
        <state>Zhejiang</state>
        <zip>323000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ningbo No.2 Hospital</name>
      <address>
        <city>Ningbo</city>
        <state>Zhejiang</state>
        <zip>315010</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ningbo No.6 Hospital</name>
      <address>
        <city>Ningbo</city>
        <state>Zhejiang</state>
        <zip>315040</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taizhou Hospital of Zhejiang Province</name>
      <address>
        <city>Taizhou</city>
        <state>Zhejiang</state>
        <zip>317000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Wenzhou Medical University</name>
      <address>
        <city>Wenzhou</city>
        <state>Zhejiang</state>
        <zip>325000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Jishuitan Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southwest Hospital</name>
      <address>
        <city>Chongqing</city>
        <zip>400038</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
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    <citation>Rasmussen LS, Johnson T, Kuipers HM, Kristensen D, Siersma VD, Vila P, Jolles J, Papaioannou A, Abildstrom H, Silverstein JH, Bonal JA, Raeder J, Nielsen IK, Korttila K, Munoz L, Dodds C, Hanning CD, Moller JT; ISPOCD2(International Study of Postoperative Cognitive Dysfunction) Investigators. Does anaesthesia cause postoperative cognitive dysfunction? A randomised study of regional versus general anaesthesia in 438 elderly patients. Acta Anaesthesiol Scand. 2003 Mar;47(3):260-6. doi: 10.1034/j.1399-6576.2003.00057.x.</citation>
    <PMID>12648190</PMID>
  </reference>
  <reference>
    <citation>Sieber FE, Zakriya KJ, Gottschalk A, Blute MR, Lee HB, Rosenberg PB, Mears SC. Sedation depth during spinal anesthesia and the development of postoperative delirium in elderly patients undergoing hip fracture repair. Mayo Clin Proc. 2010 Jan;85(1):18-26. doi: 10.4065/mcp.2009.0469. Erratum In: Mayo Clin Proc. 2010 Apr;85(4):400. Dosage error in article text.</citation>
    <PMID>20042557</PMID>
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    <citation>Abou-Setta AM, Beaupre LA, Rashiq S, Dryden DM, Hamm MP, Sadowski CA, Menon MR, Majumdar SR, Wilson DM, Karkhaneh M, Mousavi SS, Wong K, Tjosvold L, Jones CA. Comparative effectiveness of pain management interventions for hip fracture: a systematic review. Ann Intern Med. 2011 Aug 16;155(4):234-45. doi: 10.7326/0003-4819-155-4-201108160-00346.</citation>
    <PMID>21844549</PMID>
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    <citation>Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. doi: 10.7326/0003-4819-113-12-941.</citation>
    <PMID>2240918</PMID>
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    <citation>Folstein MF, Folstein SE, McHugh PR. &quot;Mini-mental state&quot;. A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.</citation>
    <PMID>1202204</PMID>
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    <citation>Trzepacz PT, Mittal D, Torres R, Kanary K, Norton J, Jimerson N. Validation of the Delirium Rating Scale-revised-98: comparison with the delirium rating scale and the cognitive test for delirium. J Neuropsychiatry Clin Neurosci. 2001 Spring;13(2):229-42. doi: 10.1176/jnp.13.2.229. Erratum In: J Neuropsychiatry Clin Neurosci 2001 Summer;13(3):433.</citation>
    <PMID>11449030</PMID>
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    <citation>Huang MC, Lee CH, Lai YC, Kao YF, Lin HY, Chen CH. Chinese version of the Delirium Rating Scale-Revised-98: reliability and validity. Compr Psychiatry. 2009 Jan-Feb;50(1):81-5. doi: 10.1016/j.comppsych.2008.05.011. Epub 2008 Aug 23.</citation>
    <PMID>19059519</PMID>
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    <citation>McHorney CA, Ware JE Jr, Lu JF, Sherbourne CD. The MOS 36-item Short-Form Health Survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. Med Care. 1994 Jan;32(1):40-66. doi: 10.1097/00005650-199401000-00004.</citation>
    <PMID>8277801</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <results_first_submitted>October 26, 2020</results_first_submitted>
  <results_first_submitted_qc>January 27, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">January 28, 2021</results_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">May 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wenzhou Medical University</investigator_affiliation>
    <investigator_full_name>Ting Li</investigator_full_name>
    <investigator_title>associate chief physician</investigator_title>
  </responsible_party>
  <keyword>delirium</keyword>
  <keyword>general anesthesia</keyword>
  <keyword>regional anesthesia</keyword>
  <keyword>elderly patient</keyword>
  <keyword>hip fracture</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
    <mesh_term>Emergence Delirium</mesh_term>
    <mesh_term>Hip Fractures</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 8, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/80/NCT02213380/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 15, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/80/NCT02213380/SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Group RA</title>
          <description>Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA</description>
        </group>
        <group group_id="P2">
          <title>Group GA</title>
          <description>General anesthesia (general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Underwent Randomization</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="476"/>
                <participants group_id="P2" count="474"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="471"/>
                <participants group_id="P2" count="471"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Not treated</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Per-protocol Analysis</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="471"/>
                <participants group_id="P2" count="471"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="439"/>
                <participants group_id="P2" count="435"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="36"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="36"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>950 patients were randomized and by intention-to-treat principal, 471 patients entered in to the RA group and 471 entered into the GA group.</population>
      <group_list>
        <group group_id="B1">
          <title>Group GA</title>
          <description>General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.</description>
        </group>
        <group group_id="B2">
          <title>Group RA</title>
          <description>Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="471"/>
            <count group_id="B2" value="471"/>
            <count group_id="B3" value="942"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="471"/>
                    <count group_id="B2" value="471"/>
                    <count group_id="B3" value="942"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76.69" spread="6.57"/>
                    <measurement group_id="B2" value="77" spread="6.5"/>
                    <measurement group_id="B3" value="76.84" spread="6.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="471"/>
                    <count group_id="B2" value="471"/>
                    <count group_id="B3" value="942"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="352"/>
                    <measurement group_id="B2" value="343"/>
                    <measurement group_id="B3" value="695"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="119"/>
                    <measurement group_id="B2" value="128"/>
                    <measurement group_id="B3" value="247"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="471"/>
                    <count group_id="B2" value="471"/>
                    <count group_id="B3" value="942"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21.79" spread="3.33"/>
                    <measurement group_id="B2" value="21.71" spread="3.48"/>
                    <measurement group_id="B3" value="21.75" spread="3.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Level of education</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="471"/>
                    <count group_id="B2" value="471"/>
                    <count group_id="B3" value="942"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Illiterate</title>
                  <measurement_list>
                    <measurement group_id="B1" value="282"/>
                    <measurement group_id="B2" value="286"/>
                    <measurement group_id="B3" value="568"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Elementary school</title>
                  <measurement_list>
                    <measurement group_id="B1" value="119"/>
                    <measurement group_id="B2" value="124"/>
                    <measurement group_id="B3" value="243"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Secondary school or above</title>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="131"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Type of fracture</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="471"/>
                    <count group_id="B2" value="471"/>
                    <count group_id="B3" value="942"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Femoral neck fracture</title>
                  <measurement_list>
                    <measurement group_id="B1" value="264"/>
                    <measurement group_id="B2" value="278"/>
                    <measurement group_id="B3" value="542"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Fracture of femoral head</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Intertrochanteric</title>
                  <measurement_list>
                    <measurement group_id="B1" value="200"/>
                    <measurement group_id="B2" value="183"/>
                    <measurement group_id="B3" value="383"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Subtrochanteric</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ASA class</title>
          <description>American Society of Anesthesiologists (ASA) physical status classification system is a system for assessing the fitness of patients before surgery, the higher of the grade the worse.&#xD;
I A normal healthy patient II A patient with mild systemic disease III A patient with severe systemic disease IV A patient with severe systemic disease that is a constant threat to life.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="471"/>
                    <count group_id="B2" value="471"/>
                    <count group_id="B3" value="942"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>I</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>II</title>
                  <measurement_list>
                    <measurement group_id="B1" value="363"/>
                    <measurement group_id="B2" value="350"/>
                    <measurement group_id="B3" value="713"/>
                  </measurement_list>
                </category>
                <category>
                  <title>III</title>
                  <measurement_list>
                    <measurement group_id="B1" value="90"/>
                    <measurement group_id="B2" value="98"/>
                    <measurement group_id="B3" value="188"/>
                  </measurement_list>
                </category>
                <category>
                  <title>IV</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mini-mental State Examination</title>
          <description>The Mini-Mental State Exam (MMSE) is a widely used test of cognitive function among the elderly; it includes tests of orientation, attention, memory, language and visual-spatial skills, and measured by scores range from zero [severe cognitive impairment] to 30 [normal cognition].</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="471"/>
                    <count group_id="B2" value="471"/>
                    <count group_id="B3" value="942"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19.59" spread="6.41"/>
                    <measurement group_id="B2" value="19.39" spread="6.27"/>
                    <measurement group_id="B3" value="19.49" spread="6.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pre-operative delirium</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="471"/>
                    <count group_id="B2" value="471"/>
                    <count group_id="B3" value="942"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Comorbidities</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Respiratory system disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="471"/>
                    <count group_id="B2" value="471"/>
                    <count group_id="B3" value="942"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Central nervous system disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="471"/>
                    <count group_id="B2" value="471"/>
                    <count group_id="B3" value="942"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="65"/>
                    <measurement group_id="B3" value="122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urinary system disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="471"/>
                    <count group_id="B2" value="471"/>
                    <count group_id="B3" value="942"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="117"/>
                    <measurement group_id="B2" value="112"/>
                    <measurement group_id="B3" value="229"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gastrointestinal system disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="471"/>
                    <count group_id="B2" value="471"/>
                    <count group_id="B3" value="942"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="145"/>
                    <measurement group_id="B2" value="173"/>
                    <measurement group_id="B3" value="318"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematologic system disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="471"/>
                    <count group_id="B2" value="471"/>
                    <count group_id="B3" value="942"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cardiovascular system disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="471"/>
                    <count group_id="B2" value="471"/>
                    <count group_id="B3" value="942"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="300"/>
                    <measurement group_id="B2" value="280"/>
                    <measurement group_id="B3" value="580"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Post-operative Delirium in 7 Days Post Operation</title>
        <description>Post-operative delirium diagnosed with Confusion Assessment Method</description>
        <time_frame>in 7 days post operation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group RA</title>
            <description>Method of anesthesia: regional anesthesia&#xD;
method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia.&#xD;
General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.&#xD;
Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA</description>
          </group>
          <group group_id="O2">
            <title>Group GA</title>
            <description>Method of anesthesia: general anesthesia&#xD;
method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia.&#xD;
General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.&#xD;
Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Post-operative Delirium in 7 Days Post Operation</title>
          <description>Post-operative delirium diagnosed with Confusion Assessment Method</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="471"/>
                <count group_id="O2" value="470"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Post-operative Delirium</title>
        <description>Number of participants with delirium includes patients who had delirium in the post in the first 7 post-operative days.&#xD;
The severity of delirium was described using a severity score from 0 (no delirium) to 39 (highest severity) and subtypes of delirium as hyperactive, hypoactive or mixed.</description>
        <time_frame>within fist 7days post operation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group RA</title>
            <description>Method of anesthesia: regional anesthesia&#xD;
method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia.&#xD;
General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.&#xD;
Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA</description>
          </group>
          <group group_id="O2">
            <title>Group GA</title>
            <description>Method of anesthesia: general anesthesia&#xD;
method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia.&#xD;
General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.&#xD;
Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Post-operative Delirium</title>
          <description>Number of participants with delirium includes patients who had delirium in the post in the first 7 post-operative days.&#xD;
The severity of delirium was described using a severity score from 0 (no delirium) to 39 (highest severity) and subtypes of delirium as hyperactive, hypoactive or mixed.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>1 episode of POD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2 episodes of POD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=3 episodes of POD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Severity of Delirium</title>
        <description>The worst severity scores of delirium was diagnosed with the DRS-R-98 within 7 days</description>
        <time_frame>within first 7days post operation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group RA</title>
            <description>Method of anesthesia: regional anesthesia&#xD;
method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia.&#xD;
General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.&#xD;
Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA</description>
          </group>
          <group group_id="O2">
            <title>Group GA</title>
            <description>Method of anesthesia: general anesthesia&#xD;
method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia.&#xD;
General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.&#xD;
Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA</description>
          </group>
        </group_list>
        <measure>
          <title>Severity of Delirium</title>
          <description>The worst severity scores of delirium was diagnosed with the DRS-R-98 within 7 days</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.48" spread="7.16"/>
                    <measurement group_id="O2" value="24.22" spread="7.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Subtypes of Delirium Diagnosed in 7 Days Post Operation</title>
        <description>The subtypes of delirium diagnosed with the Delirium Rating Scale-Revised-98 (DRS-R-98).&#xD;
Patients with the hyperactive subtype may be agitated, disoriented, and delusional, and may experience hallucinations. This presentation can be confused with that of schizophrenia, agitated dementia, or a psychotic disorder.</description>
        <time_frame>within first 7 days post operation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group RA</title>
            <description>Method of anesthesia: regional anesthesia&#xD;
method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia.&#xD;
General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.&#xD;
Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA</description>
          </group>
          <group group_id="O2">
            <title>Group GA</title>
            <description>Method of anesthesia: general anesthesia&#xD;
method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia.&#xD;
General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.&#xD;
Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA</description>
          </group>
        </group_list>
        <measure>
          <title>The Subtypes of Delirium Diagnosed in 7 Days Post Operation</title>
          <description>The subtypes of delirium diagnosed with the Delirium Rating Scale-Revised-98 (DRS-R-98).&#xD;
Patients with the hyperactive subtype may be agitated, disoriented, and delusional, and may experience hallucinations. This presentation can be confused with that of schizophrenia, agitated dementia, or a psychotic disorder.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hyperactive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hypoactive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mixed motor</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No motor</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>30 Day Mortality</title>
        <description>Mortality within 30 days post operation</description>
        <time_frame>30 days after surgery</time_frame>
        <population>6 patients in RA were lost to 30-day follow-up and 24 patients in GA were lost to 30-day follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>Group RA</title>
            <description>Method of anesthesia: regional anesthesia&#xD;
method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia.&#xD;
General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.&#xD;
Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA</description>
          </group>
          <group group_id="O2">
            <title>Group GA</title>
            <description>Method of anesthesia: general anesthesia&#xD;
method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia.&#xD;
General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.&#xD;
Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA</description>
          </group>
        </group_list>
        <measure>
          <title>30 Day Mortality</title>
          <description>Mortality within 30 days post operation</description>
          <population>6 patients in RA were lost to 30-day follow-up and 24 patients in GA were lost to 30-day follow-up.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="465"/>
                <count group_id="O2" value="447"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Acute Pain Score Using Visual Analogue Scale (VAS)</title>
        <description>The worst pain score within 7 days post-operation in both groups. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between no pain(0 point) to worst pain (100 points).</description>
        <time_frame>In 7days post operation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group RA</title>
            <description>Method of anesthesia: regional anesthesia&#xD;
method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia.&#xD;
General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.&#xD;
Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA</description>
          </group>
          <group group_id="O2">
            <title>Group GA</title>
            <description>Method of anesthesia: general anesthesia&#xD;
method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia.&#xD;
General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.&#xD;
Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA</description>
          </group>
        </group_list>
        <measure>
          <title>Acute Pain Score Using Visual Analogue Scale (VAS)</title>
          <description>The worst pain score within 7 days post-operation in both groups. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between no pain(0 point) to worst pain (100 points).</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="471"/>
                <count group_id="O2" value="470"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="20"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Length of Hospital Stay</title>
        <description>Length of hospital stay are measured from the anesthesia starting day to the discharge day</description>
        <time_frame>till the day of discharge from hospital, an average of 7 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group RA</title>
            <description>Method of anesthesia: regional anesthesia&#xD;
method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia.&#xD;
General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.&#xD;
Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA</description>
          </group>
          <group group_id="O2">
            <title>Group GA</title>
            <description>Method of anesthesia: general anesthesia&#xD;
method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia.&#xD;
General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.&#xD;
Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Hospital Stay</title>
          <description>Length of hospital stay are measured from the anesthesia starting day to the discharge day</description>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="471"/>
                <count group_id="O2" value="471"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" lower_limit="5" upper_limit="10"/>
                    <measurement group_id="O2" value="7" lower_limit="6" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Costs of Anesthetic Procedure</title>
        <description>Costs of anesthetic procedure only</description>
        <time_frame>1 day after operation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group RA</title>
            <description>Method of anesthesia: regional anesthesia&#xD;
method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia.&#xD;
General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.&#xD;
Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA</description>
          </group>
          <group group_id="O2">
            <title>Group GA</title>
            <description>Method of anesthesia: general anesthesia&#xD;
method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia.&#xD;
General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.&#xD;
Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA</description>
          </group>
        </group_list>
        <measure>
          <title>Costs of Anesthetic Procedure</title>
          <description>Costs of anesthetic procedure only</description>
          <units>dollars</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="471"/>
                <count group_id="O2" value="471"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="159" lower_limit="110" upper_limit="220"/>
                    <measurement group_id="O2" value="268" lower_limit="201" upper_limit="359"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total In-hospital Costs</title>
        <description>Entire expenditure in-hospital</description>
        <time_frame>till the day of discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group RA</title>
            <description>Method of anesthesia: regional anesthesia&#xD;
method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia.&#xD;
General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.&#xD;
Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA</description>
          </group>
          <group group_id="O2">
            <title>Group GA</title>
            <description>Method of anesthesia: general anesthesia&#xD;
method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia.&#xD;
General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.&#xD;
Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA</description>
          </group>
        </group_list>
        <measure>
          <title>Total In-hospital Costs</title>
          <description>Entire expenditure in-hospital</description>
          <units>dollars</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="471"/>
                <count group_id="O2" value="471"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5582" lower_limit="4598" upper_limit="7362"/>
                    <measurement group_id="O2" value="5908" lower_limit="4778" upper_limit="7631"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>6 Months Incidence of Delirium</title>
        <description>in clinic or at their residence, diagnosed with Confusion Assessment Method (CAM)</description>
        <time_frame>6 months after discharge</time_frame>
        <posting_date>12/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>12 Months Incidence of Delirium</title>
        <description>in clinic or at their residence, diagnosed with Confusion Assessment Method (CAM)</description>
        <time_frame>12 months after discharge</time_frame>
        <posting_date>12/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>6 Months Quality of Life</title>
        <description>using 36-Item Short Form Survey (SF-36) questionnaire</description>
        <time_frame>6 months after discharge</time_frame>
        <posting_date>12/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>12 Months Quality of Life</title>
        <description>using 36-Item Short Form Survey (SF-36) questionnaire</description>
        <time_frame>12months after discharge</time_frame>
        <posting_date>12/2023</posting_date>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Before discharge day with an average of 7 days, and for all cause mortality, is up to postoperative 30 days.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Group RA</title>
          <description>Method of anesthesia: regional anesthesia&#xD;
method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia.&#xD;
General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.&#xD;
Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA</description>
        </group>
        <group group_id="E2">
          <title>Group GA</title>
          <description>Method of anesthesia: general anesthesia&#xD;
method of anesthesia: Method of anesthesia includes: general anesthesia and regional anesthesia.&#xD;
General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.&#xD;
Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="471"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="471"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="471"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="471"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="471"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="471"/>
              </event>
              <event>
                <sub_title>acute left heart failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="471"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="471"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>acute gastric perforation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="471"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="471"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>stroke</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="471"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="471"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>lung infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="471"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="471"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="83" subjects_at_risk="471"/>
                <counts group_id="E2" subjects_affected="79" subjects_at_risk="471"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <description>Anemia (myoglobin&lt; 81g/L)</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="471"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="471"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="471"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="471"/>
              </event>
              <event>
                <sub_title>Chest distress</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="471"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="471"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea and vomiting</sub_title>
                <counts group_id="E1" subjects_affected="47" subjects_at_risk="471"/>
                <counts group_id="E2" subjects_affected="34" subjects_at_risk="471"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="471"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="471"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="471"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="471"/>
              </event>
              <event>
                <sub_title>Acute gastric perforation*</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="471"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="471"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Numbness in the back</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="471"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="471"/>
              </event>
              <event>
                <sub_title>Shiver</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="471"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="471"/>
              </event>
              <event>
                <sub_title>Pharyngodynia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="471"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="471"/>
              </event>
              <event>
                <sub_title>Hematoma in neck</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="471"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="471"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <description>Hyperglycaemia (The elevated blood glucose is clinically significant compared to the baseline value, judged by the investigator)</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="471"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="471"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache and dizziness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="471"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="471"/>
              </event>
              <event>
                <sub_title>Stroke</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="471"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="471"/>
              </event>
              <event>
                <sub_title>Cerebrospinal fluid leak</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="471"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="471"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="471"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="471"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoxemia</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="471"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="471"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin allergy</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="471"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="471"/>
              </event>
              <event>
                <sub_title>Mild burns of skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="471"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="471"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="471"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="471"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="471"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="471"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Ting Li</name_or_title>
      <organization>The second affiliated hospital and Yuying children's hospital of Wenzhou medical university</organization>
      <phone>008613587876896</phone>
      <email>liting1021@aliyun.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02213380
org study id: RAGA-Delirium
nct id: NCT02213380
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is evaluate postoperative delirium after general anesthesia and
      regional anesthesia in elderly patients undergoing hip fracture surgery. Our research
      hypotheses are: (1) regional anesthesia may contribute to decrease the incidence of
      postoperative delirium. (2) Regional anesthesia may improve the outcome of elderly patient
      and reduce healthcare costs associated with postoperative delirium. (3) Postoperative
      delirium may result in poor long-term functional outcomes.
Postoperative delirium (POD) is an acute confusional state associated with changes in
      consciousness, arousal level and cognitive status. Elderly patients with hip fractures have
      the high incidence of delirium. The high risk factor of delirium include: Age 65 years or
      older, cognitive impairment/dementia, current hip fracture, severe illness and so on. Many
      previous studies predict that the majority of general anesthetic and sedative agents can
      favour postoperative delirium. However, none of studies have investigated the effect of
      general anesthesia and the effect of regional anesthesia and general anesthesia on the
      postoperative delirium in elderly patients undergoing hip fracture surgery in China. This
      multicentre, prospective, randomized controlled clinical trial is designed to evaluate
      postoperative delirium after general anesthesia and regional anesthesia in elderly patients
      undergoing hip fracture surgery. Our research hypotheses are: (1) regional anesthesia may
      contribute to decrease the incidence of postoperative delirium. (2) Regional anesthesia may
      improve the outcome of elderly patient and reduce healthcare costs associated with
      postoperative delirium. (3) Postoperative delirium may result in poor long-term functional
      outcomes.

      This trial has the following nine investigational centers: Department of Anesthesiology, The
      Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University, Wenzhou,
      China; Department of Anesthesiology, Tongji Hospital, Tongji Medical college, Huazhong
      University of Science & Technology, Wuhan, China; Department of Anesthesiology, West China
      Hospital of Sichuan University, Chengdu, China; Department of Anesthesiology, Southwest
      Hospital, Chongqing, China; Department of Anesthesiology, The Second Affiliated Hospital of
      Zhejiang University School of Medicine, Hangzhou, China; Department of Anesthesiology,
      Beijing Jishuitan Hospital, Beijing, China; Department of Anesthesiology, The First
      Affiliated Hospital of Nanchang University, Nanchang, China; Department of Anesthesiology,
      The Second Hospital of Anhui Medical University, Anhui, China; The First Affiliated Hospital
      of Wenzhou Medical University, Wenzhou, China;

      Eligible patients will be assigned into two study groups (group RA: regional anesthesia will
      be used, group GA: General anesthesia will be used) by centre-minimization randomization (web
      or telephone). There are 3 stratification factors: age (65-79,≥80), presence of delirium(yes,
      no), dementia(yes, no). There will be two teams of investigators involved in trial procedure
      and the patient's follow-up. Investigator A (experienced anesthetist), who are competent in
      caring for patients undergoing hip fracture surgery, will perform following works, which
      includes informed consent, randomization, anesthesia and recovery parameters. Investigator B
      will visit patient the day before surgery and 7days after surgery or until discharge to
      assess patient for presence, type and severity of delirium, collect other data during in
      hospital stay and follow up patients at 6 and 12 months. Investigator B will receive uniform
      training of using of CAM, Delirium Rating Scale-Revised-98 (DRS-R-98), MMSE and other test
      used in this trial) and will be not clear about protocol.

      Within 24 h before surgery, cognitive function of each patient will be assessed with the
      MMSE, the presence of delirium will be diagnosed with the CAM, the type and severity of
      delirium will be assessed with DRS-R-98 and the pain will be assessed with a 100-mm visual
      analog scale (VAS). Routine monitoring (NBP, continuous ECG, and pulse oximetry) was
      initiated on all patients. Premedication for anesthesia will be avoided before surgery. Any
      medication impairing cognitive function will not be recommended, if administered, must be
      recorded it in detail.

      Investigator A will allocated the patient into group GA or group RA according the
      centre-randomization with a unique registration number for each eligible patient. Treatment
      protocols for both groups will also stipulate no sedative be administrated during operation.
      Routine monitoring was initiated on all patients. Hypotension (Systolic Blood Pressure<90mmHg
      or drop of Mean Arterial Pressure>30%) should be treated with vasoactive agents or fluid
      boluses as deemed appropriate by anesthetists.

      Postoperative analgesia will be administered according to the local procedures of each
      clinical trial site, aiming to maintain a VAS pain score ≤ 30 mm. Both groups will receive
      routine postoperative care on orthopedic ward.

      All randomized patients will be followed up to 7 days after surgery (or discharge from the
      hospital). The 7 days follow-up includes: CAM, DRS-98-R (if applicable), VAS, Analgesic use
      (if applicable), Sedative use (if applicable), Post-operative morbidity and laboratory
      results (including serum hemoglobin, hematocrit, leucocytes, aspartate aminotransferase
      (AST), alanine aminotransferase (ALT), albumin, serum creatinine and urea concentrations,
      serum sodium and potassium and serum glucose concentration). Concomitant medications, adverse
      events and serious adverse events are record in all study visits. Economic parameters
      include: time to be discharged from post operation, total cost in hospital and cost for
      anesthesia of patient. Investigator B will also assess patient with POD in clinic or at their
      residence at 6 and 12 months to assess for presence of delirium, its type and severity (CAM,
      DRS-98-R), cognitive function using MMSE, and quality of life using The MOS 36-item
      Short-Form Health Survey (SF-36) questionnaire.

      The study will be monitored regularly by the clinical research associate (CRA) through visits
      or telephone. CRA will verify the consistency of the data recorded on the case report forms
      with the source documents and the management of therapeutic batches, the presence and
      completeness of the investigator file.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
masking description: Data collectors or outcome assessors, e.g. the medical staff who provide post-operative care in the ward and visit patients for preoperational assessment, hospital visits and subsequent follow-ups, will be blinded from group allocation throughout the study.
measure: Number of Participants With Post-operative Delirium in 7 Days Post Operation
time frame: in 7 days post operation
description: Post-operative delirium diagnosed with Confusion Assessment Method
measure: Number of Participants With Post-operative Delirium
time frame: within fist 7days post operation
description: Number of participants with delirium includes patients who had delirium in the post in the first 7 post-operative days.
The severity of delirium was described using a severity score from 0 (no delirium) to 39 (highest severity) and subtypes of delirium as hyperactive, hypoactive or mixed.
measure: Severity of Delirium
time frame: within first 7days post operation
description: The worst severity scores of delirium was diagnosed with the DRS-R-98 within 7 days
measure: The Subtypes of Delirium Diagnosed in 7 Days Post Operation
time frame: within first 7 days post operation
description: The subtypes of delirium diagnosed with the Delirium Rating Scale-Revised-98 (DRS-R-98).
Patients with the hyperactive subtype may be agitated, disoriented, and delusional, and may experience hallucinations. This presentation can be confused with that of schizophrenia, agitated dementia, or a psychotic disorder.
measure: 30 Day Mortality
time frame: 30 days after surgery
description: Mortality within 30 days post operation
measure: Acute Pain Score Using Visual Analogue Scale (VAS)
time frame: In 7days post operation
description: The worst pain score within 7 days post-operation in both groups. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between no pain(0 point) to worst pain (100 points).
measure: Length of Hospital Stay
time frame: till the day of discharge from hospital, an average of 7 days
description: Length of hospital stay are measured from the anesthesia starting day to the discharge day
measure: Costs of Anesthetic Procedure
time frame: 1 day after operation
description: Costs of anesthetic procedure only
measure: Total In-hospital Costs
time frame: till the day of discharge
description: Entire expenditure in-hospital
measure: 6 Months Incidence of Delirium
time frame: 6 months after discharge
description: in clinic or at their residence, diagnosed with Confusion Assessment Method (CAM)
measure: 12 Months Incidence of Delirium
time frame: 12 months after discharge
description: in clinic or at their residence, diagnosed with Confusion Assessment Method (CAM)
measure: 6 Months Quality of Life
time frame: 6 months after discharge
description: using 36-Item Short Form Survey (SF-36) questionnaire
measure: 12 Months Quality of Life
time frame: 12months after discharge
description: using 36-Item Short Form Survey (SF-36) questionnaire
arm group label: group GA
arm group type: Other
description: General anesthesia
arm group label: group RA
arm group type: Other
description: Regional anesthesia
intervention type: Procedure
intervention name: method of anesthesia
description: General anesthesia and regional anesthesia.
General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.
Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA
arm group label: group GA
arm group label: group RA
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Fang Gao, M.D.
role: Study Chair
affiliation: The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University
last name: Qingquan Lian, M.D.
role: Study Chair
affiliation: The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University
last name: Jun Li, M.D.
role: Study Director
affiliation: The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University
last name: Ting Li, M.D.
role: Principal Investigator
affiliation: The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University
last name: Joice Yeung, M.D.
role: Study Director
affiliation: Heart of England NHS Foundation Trust
last name: Teresa Moledy
role: Study Director
affiliation: Heart of England NHS Foundation Trust
facility: 
facility: 
facility: 
facility: 
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facility: 
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facility: 
country: China
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responsible party type: Principal Investigator
investigator affiliation: Wenzhou Medical University
investigator full name: Ting Li
investigator title: associate chief physician
mesh term: Delirium
mesh term: Emergence Delirium
mesh term: Hip Fractures
mesh term: Anesthetics
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