<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/NCT03249701</url>
  </required_header>
  <id_info>
    <org_study_id>SZH-A-20170501-R2</org_study_id>
    <nct_id>NCT03249701</nct_id>
  </id_info>
  <brief_title>Electrical Acupoint Stimulation for Postoperative Recovery</brief_title>
  <acronym>EAS</acronym>
  <official_title>Electrical Acupoint Stimulation for Postoperative Recovery After Knee Arthroplasty. A Randomized, Double-blind, Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shandong University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shandong University of Traditional Chinese Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study investigates electrical acupoint stimulation (EAS) administered in peri-operation&#xD;
      for improving postoperative recovery in elder patients, who accept knee arthroplasty. the&#xD;
      surgery cause to change of stress response, which might be associated with postoperative&#xD;
      recovery of patient Totally, three groups are created, 1/3 participants receive&#xD;
      transcutaneous electrical acupoint stimulation, 1/3 participants receive electroacupuncture,&#xD;
      the rest 1/3 will use sham transcutaneous electrical acupoint stimulation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Theoretically, the application of electrical acupoint stimulation (EAS) base on the theory of&#xD;
      traditional Chinese medicine. It deems that a surgery might consume Qi, then cause to&#xD;
      imbalance of Qi and Blood, especially in elder patients. Besides, surgery lead to change of&#xD;
      stress response (hormones). The EAS administration intra-operatively perhaps be beneficial to&#xD;
      recovery of patients, reduce the incidence of postoperative complications. The main possible&#xD;
      mechanism was stress response regulation. The hypothesis is that the EAS improve&#xD;
      postoperative recovery of patient through regulating stress response.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">May 1, 2018</start_date>
  <completion_date type="Anticipated">October 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2019</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>
    <intervention_model_description>The participants divided into 3 groups randomized, one group receive transcutaneous electrical acupoint stimulation, one group receive electroacupuncture, the third group only connect to acupoints without stimulation.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>The intervention administered randomly to the participants. The participants, care providers, investigator, outcomes assessor done their job, separately. The blind will be controlled by a assigned investigator.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The postoperative recovery</measure>
    <time_frame>7 days</time_frame>
    <description>Record the postoperative recovery after surgery through quality of recovery-40 questionnaire.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The adverse event</measure>
    <time_frame>7 days</time_frame>
    <description>Record all the adverse events appeared during the entire trail, which might cause to skin rash, allergic reaction, et al.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The level of stress response</measure>
    <time_frame>up to 7 days</time_frame>
    <description>Assess the level of preoperative stress response at 1, 3, 7 days after operation. It mainly include Adrenocorticotropic Hormone (ACTH), Cortisol (COR), Adrenaline (E), norepinephrine (NE). All measures unit is pg/ml.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative complications</measure>
    <time_frame>7 days</time_frame>
    <description>Record the incidence of any postoperative complications during 7 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The level of inflammatory response by TNF-a, IL-1, IL-6, IL-10</measure>
    <time_frame>up to 7 days</time_frame>
    <description>Assess the level of perioperative inflammatory response at 1, 3, 7 days after operation. It mainly include Tumor Necrosis Factor-a (TNF-a), Interleukins-1 (IL-1), Interleukins-6 (IL-6), Interleukins-10 (IL-10). All measures unit is ng/ml.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The level of inflammatory response by C-reactive protein</measure>
    <time_frame>up to 7 days</time_frame>
    <description>Assess the level of perioperative inflammatory response at 1, 3, 7 days after operation through C-reactive protein. the unit is mg/L.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Age in years</measure>
    <time_frame>1 day</time_frame>
    <description>Once patients enrolled, the age (years) need to be recorded ahead of operation.</description>
  </other_outcome>
  <other_outcome>
    <measure>ASA classification status</measure>
    <time_frame>1 day</time_frame>
    <description>Once patients enrolled, the ASA condition need to be recorded ahead of operation depend on the ASA classification.</description>
  </other_outcome>
  <other_outcome>
    <measure>Gender</measure>
    <time_frame>1 day</time_frame>
    <description>Once patients enrolled, the gender need to be recorded ahead of operation.</description>
  </other_outcome>
  <other_outcome>
    <measure>Weight in kilograms</measure>
    <time_frame>1 day</time_frame>
    <description>Once patients enrolled, the weight (kilograms) need to be recorded ahead of operation.</description>
  </other_outcome>
  <other_outcome>
    <measure>Height in meters</measure>
    <time_frame>1 day</time_frame>
    <description>Once patients enrolled, the height (meters) need to be recorded ahead of operation.</description>
  </other_outcome>
  <other_outcome>
    <measure>BMI in kg/m^2</measure>
    <time_frame>1 day</time_frame>
    <description>Once patients enrolled, the BMI (weight and height will be combined to report BMI in kg/m^2) will be reported base on weight and height ahead of operation.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Postoperative Complications</condition>
  <condition>Postoperative Nausea and Vomiting</condition>
  <condition>Postoperative Infection</condition>
  <condition>Postoperative Delirium</condition>
  <condition>Postoperative Pneumonia</condition>
  <condition>Deep Vein Thrombosis</condition>
  <condition>Postoperative Retention of Urine</condition>
  <condition>Postoperative Recovery</condition>
  <arm_group>
    <arm_group_label>TEAS group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transcutaneous Electrical Acupoint Stimulation on Neiguan, Quchi, Zusanli, Sanyinjiao. Intensity: maximal tolerance by subject; Time span: 30minutes before anesthesia induction and 30 minutes after wound closure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Electroacupuncture group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Hand-needle on Neiguan, Quchi, Zusanli, Sanyinjiao.Intensity: maximal tolerance by subject; Time span: 30minutes before anesthesia induction and 30 minutes after wound closure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham TEAS group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham transcutaneous electrical acupoint stimulation on Neiguan, Quchi, Zusanli, Sanyinjiao; Intensity: maximal tolerance by subject; Time span: 30minutes before anesthesia induction and 30 minutes after wound closure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcutaneous Electrical Acupoint Stimulation</intervention_name>
    <description>The intervention will be administered by electrical acupoint machine, the brand is Great Wall.</description>
    <arm_group_label>TEAS group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electroacupuncture</intervention_name>
    <description>The intervention will be administered by electrical acupoint machine, the brand is Great Wall.</description>
    <arm_group_label>Electroacupuncture group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>sham Transcutaneous Electrical Acupoint Stimulation</intervention_name>
    <description>The intervention will be administered by transcutaneous electrical acupoint machine, even no truly actualized.</description>
    <arm_group_label>sham TEAS group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Agree to sign the contract&#xD;
&#xD;
          -  The patients receive total hip or knee arthroplasty&#xD;
&#xD;
          -  Epidural anesthesia administered&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patients' age out of range setting&#xD;
&#xD;
          -  Forbidden to the administration of transcutaneous electrical acupoint stimulation&#xD;
&#xD;
          -  Communication disorder&#xD;
&#xD;
          -  The patients who had medical history of cerebral vascular diseases, deep vein&#xD;
             thrombosis, urinary retention, nausea and vomiting.&#xD;
&#xD;
          -  The patients who attended another trial in the past three months&#xD;
&#xD;
          -  Emergency surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Su Fan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shandong University of Traditional Chinese Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>zhang weiliang, MD</last_name>
    <phone>086-0531-68617021</phone>
    <phone_ext>6114</phone_ext>
    <email>hezhangweiliang@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Su Fan, MD</last_name>
    <phone>086-0531-68617023</phone>
    <phone_ext>6114</phone_ext>
    <email>boatsail@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Affiliated hospital of shandong university of traditional chinese medicine</name>
      <address>
        <city>Ji'nan</city>
        <state>Shandong</state>
        <zip>250011</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>zhang weiliang, MD</last_name>
      <phone>086-0531-68617021</phone>
      <phone_ext>6114</phone_ext>
      <email>hezhangweiliang@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Su Fan, MD</last_name>
      <phone>086-0531-68617023</phone>
      <phone_ext>6114</phone_ext>
      <email>boatsail@163.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Coburn M, Fahlenkamp A, Zoremba N, Schaelte G. Postoperative cognitive dysfunction: Incidence and prophylaxis. Anaesthesist. 2010 Feb;59(2):177-84; quiz 185. doi: 10.1007/s00101-009-1657-2.</citation>
    <PMID>20084351</PMID>
  </results_reference>
  <results_reference>
    <citation>Choi JB, Shim YH, Lee YW, Lee JS, Choi JR, Chang CH. Incidence and risk factors of postoperative nausea and vomiting in patients with fentanyl-based intravenous patient-controlled analgesia and single antiemetic prophylaxis. Yonsei Med J. 2014 Sep;55(5):1430-5. doi: 10.3349/ymj.2014.55.5.1430.</citation>
    <PMID>25048507</PMID>
  </results_reference>
  <results_reference>
    <citation>Office of the Surgeon General (US); National Heart, Lung, and Blood Institute (US). The Surgeon General's Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism. Rockville (MD): Office of the Surgeon General (US); 2008. Available from http://www.ncbi.nlm.nih.gov/books/NBK44178/</citation>
    <PMID>20669525</PMID>
  </results_reference>
  <results_reference>
    <citation>Montazeri AS, Hamidzadeh A, Raei M, Mohammadiun M, Montazeri AS, Mirshahi R, Rohani H. Evaluation of Oral Ginger Efficacy against Postoperative Nausea and Vomiting: A Randomized, Double - Blinded Clinical Trial. Iran Red Crescent Med J. 2013 Dec;15(12):e12268. doi: 10.5812/ircmj.12268. Epub 2013 Dec 5.</citation>
    <PMID>24693389</PMID>
  </results_reference>
  <results_reference>
    <citation>Sorrell JM. Postoperative cognitive dysfunction in older adults: a call for nursing involvement. J Psychosoc Nurs Ment Health Serv. 2014 Nov;52(11):17-20. doi: 10.3928/02793695-20141021-03.</citation>
    <PMID>25375388</PMID>
  </results_reference>
  <results_reference>
    <citation>Ge Y, Ma Z, Shi H, Zhao Y, Gu X, Wei H. [Incidence and risk factors of postoperative cognitive dysfunction in patients underwent coronary artery bypass grafting surgery]. Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2014 Oct;39(10):1049-55. doi: 10.11817/j.issn.1672-7347.2014.10.011. Chinese.</citation>
    <PMID>25355258</PMID>
  </results_reference>
  <results_reference>
    <citation>Tsay SL, Cho YC, Chen ML. Acupressure and Transcutaneous Electrical Acupoint Stimulation in improving fatigue, sleep quality and depression in hemodialysis patients. Am J Chin Med. 2004;32(3):407-16. doi: 10.1142/S0192415X04002065.</citation>
    <PMID>15344424</PMID>
  </results_reference>
  <results_reference>
    <citation>Kabalak AA, Akcay M, Akcay F, Gogus N. Transcutaneous electrical acupoint stimulation versus ondansetron in the prevention of postoperative vomiting following pediatric tonsillectomy. J Altern Complement Med. 2005 Jun;11(3):407-13. doi: 10.1089/acm.2005.11.407.</citation>
    <PMID>15992223</PMID>
  </results_reference>
  <results_reference>
    <citation>Yao Y, Zhao Q, Gong C, Wu Y, Chen Y, Qiu L, Wu X, Chen Y. Transcutaneous Electrical Acupoint Stimulation Improves the Postoperative Quality of Recovery and Analgesia after Gynecological Laparoscopic Surgery: A Randomized Controlled Trial. Evid Based Complement Alternat Med. 2015;2015:324360. doi: 10.1155/2015/324360. Epub 2015 Jun 11.</citation>
    <PMID>26170873</PMID>
  </results_reference>
  <results_reference>
    <citation>Zheng LH, Sun H, Wang GN, Liang J, Wu HX. Effect of transcutaneous electrical acupoint stimulation on nausea and vomiting induced by patient controlled intravenous analgesia with tramadol. Chin J Integr Med. 2008 Mar;14(1):61-4. doi: 10.1007/s11655-007-9006-2.</citation>
    <PMID>18219451</PMID>
  </results_reference>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>March 30, 2018</last_update_submitted>
  <last_update_submitted_qc>March 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shandong University of Traditional Chinese Medicine</investigator_affiliation>
    <investigator_full_name>weiliang zhang</investigator_full_name>
    <investigator_title>Affiliated Hospital of Shandong University of Traditional Chinese Medicine</investigator_title>
  </responsible_party>
  <keyword>Acupoint Stimulation</keyword>
  <keyword>postoperative recovery</keyword>
  <keyword>Postoperative Complications</keyword>
  <keyword>Peri-operation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergence Delirium</mesh_term>
    <mesh_term>Urinary Retention</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Venous Thrombosis</mesh_term>
    <mesh_term>Vomiting</mesh_term>
    <mesh_term>Postoperative Complications</mesh_term>
    <mesh_term>Postoperative Nausea and Vomiting</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD sharing content included the intervention protocol, record or data collected for the primary and secondary outcome measures.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data will be available within 6 months of study completion, forever.</ipd_time_frame>
    <ipd_access_criteria>Anyone are available to access the data collected on this website with requiring to sign the Data Access Agreement.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 28, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/01/NCT03249701/ICF_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 28, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/01/NCT03249701/Prot_SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03249701
org study id: SZH-A-20170501-R2
nct id: NCT03249701
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study investigates electrical acupoint stimulation (EAS) administered in peri-operation
      for improving postoperative recovery in elder patients, who accept knee arthroplasty. the
      surgery cause to change of stress response, which might be associated with postoperative
      recovery of patient Totally, three groups are created, 1/3 participants receive
      transcutaneous electrical acupoint stimulation, 1/3 participants receive electroacupuncture,
      the rest 1/3 will use sham transcutaneous electrical acupoint stimulation.
Theoretically, the application of electrical acupoint stimulation (EAS) base on the theory of
      traditional Chinese medicine. It deems that a surgery might consume Qi, then cause to
      imbalance of Qi and Blood, especially in elder patients. Besides, surgery lead to change of
      stress response (hormones). The EAS administration intra-operatively perhaps be beneficial to
      recovery of patients, reduce the incidence of postoperative complications. The main possible
      mechanism was stress response regulation. The hypothesis is that the EAS improve
      postoperative recovery of patient through regulating stress response.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The participants divided into 3 groups randomized, one group receive transcutaneous electrical acupoint stimulation, one group receive electroacupuncture, the third group only connect to acupoints without stimulation.
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: The intervention administered randomly to the participants. The participants, care providers, investigator, outcomes assessor done their job, separately. The blind will be controlled by a assigned investigator.
measure: The postoperative recovery
time frame: 7 days
description: Record the postoperative recovery after surgery through quality of recovery-40 questionnaire.
measure: The adverse event
time frame: 7 days
description: Record all the adverse events appeared during the entire trail, which might cause to skin rash, allergic reaction, et al.
measure: The level of stress response
time frame: up to 7 days
description: Assess the level of preoperative stress response at 1, 3, 7 days after operation. It mainly include Adrenocorticotropic Hormone (ACTH), Cortisol (COR), Adrenaline (E), norepinephrine (NE). All measures unit is pg/ml.
measure: Postoperative complications
time frame: 7 days
description: Record the incidence of any postoperative complications during 7 days
measure: The level of inflammatory response by TNF-a, IL-1, IL-6, IL-10
time frame: up to 7 days
description: Assess the level of perioperative inflammatory response at 1, 3, 7 days after operation. It mainly include Tumor Necrosis Factor-a (TNF-a), Interleukins-1 (IL-1), Interleukins-6 (IL-6), Interleukins-10 (IL-10). All measures unit is ng/ml.
measure: The level of inflammatory response by C-reactive protein
time frame: up to 7 days
description: Assess the level of perioperative inflammatory response at 1, 3, 7 days after operation through C-reactive protein. the unit is mg/L.
measure: Age in years
time frame: 1 day
description: Once patients enrolled, the age (years) need to be recorded ahead of operation.
measure: ASA classification status
time frame: 1 day
description: Once patients enrolled, the ASA condition need to be recorded ahead of operation depend on the ASA classification.
measure: Gender
time frame: 1 day
description: Once patients enrolled, the gender need to be recorded ahead of operation.
measure: Weight in kilograms
time frame: 1 day
description: Once patients enrolled, the weight (kilograms) need to be recorded ahead of operation.
measure: Height in meters
time frame: 1 day
description: Once patients enrolled, the height (meters) need to be recorded ahead of operation.
measure: BMI in kg/m^2
time frame: 1 day
description: Once patients enrolled, the BMI (weight and height will be combined to report BMI in kg/m^2) will be reported base on weight and height ahead of operation.
arm group label: TEAS group
arm group type: Experimental
description: Transcutaneous Electrical Acupoint Stimulation on Neiguan, Quchi, Zusanli, Sanyinjiao. Intensity: maximal tolerance by subject; Time span: 30minutes before anesthesia induction and 30 minutes after wound closure.
arm group label: Electroacupuncture group
arm group type: Placebo Comparator
description: Hand-needle on Neiguan, Quchi, Zusanli, Sanyinjiao.Intensity: maximal tolerance by subject; Time span: 30minutes before anesthesia induction and 30 minutes after wound closure.
arm group label: sham TEAS group
arm group type: Sham Comparator
description: Sham transcutaneous electrical acupoint stimulation on Neiguan, Quchi, Zusanli, Sanyinjiao; Intensity: maximal tolerance by subject; Time span: 30minutes before anesthesia induction and 30 minutes after wound closure.
intervention type: Device
intervention name: Transcutaneous Electrical Acupoint Stimulation
description: The intervention will be administered by electrical acupoint machine, the brand is Great Wall.
arm group label: TEAS group
intervention type: Device
intervention name: Electroacupuncture
description: The intervention will be administered by electrical acupoint machine, the brand is Great Wall.
arm group label: Electroacupuncture group
intervention type: Device
intervention name: sham Transcutaneous Electrical Acupoint Stimulation
description: The intervention will be administered by transcutaneous electrical acupoint machine, even no truly actualized.
arm group label: sham TEAS group
criteria: 
gender: All
minimum age: 65 Years
maximum age: 85 Years
healthy volunteers: No
last name: Su Fan, MD
role: Principal Investigator
affiliation: Shandong University of Traditional Chinese Medicine
last name: zhang weiliang, MD
phone: 086-0531-68617021
phone ext: 6114
email: hezhangweiliang@163.com
last name: Su Fan, MD
phone: 086-0531-68617023
phone ext: 6114
email: boatsail@163.com
facility: 
contact: 
contact backup: 
country: China
citation: Coburn M, Fahlenkamp A, Zoremba N, Schaelte G. Postoperative cognitive dysfunction: Incidence and prophylaxis. Anaesthesist. 2010 Feb;59(2):177-84; quiz 185. doi: 10.1007/s00101-009-1657-2.
PMID: 20084351
citation: Choi JB, Shim YH, Lee YW, Lee JS, Choi JR, Chang CH. Incidence and risk factors of postoperative nausea and vomiting in patients with fentanyl-based intravenous patient-controlled analgesia and single antiemetic prophylaxis. Yonsei Med J. 2014 Sep;55(5):1430-5. doi: 10.3349/ymj.2014.55.5.1430.
PMID: 25048507
citation: Office of the Surgeon General (US); National Heart, Lung, and Blood Institute (US). The Surgeon General's Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism. Rockville (MD): Office of the Surgeon General (US); 2008. Available from http://www.ncbi.nlm.nih.gov/books/NBK44178/
PMID: 20669525
citation: Montazeri AS, Hamidzadeh A, Raei M, Mohammadiun M, Montazeri AS, Mirshahi R, Rohani H. Evaluation of Oral Ginger Efficacy against Postoperative Nausea and Vomiting: A Randomized, Double - Blinded Clinical Trial. Iran Red Crescent Med J. 2013 Dec;15(12):e12268. doi: 10.5812/ircmj.12268. Epub 2013 Dec 5.
PMID: 24693389
citation: Sorrell JM. Postoperative cognitive dysfunction in older adults: a call for nursing involvement. J Psychosoc Nurs Ment Health Serv. 2014 Nov;52(11):17-20. doi: 10.3928/02793695-20141021-03.
PMID: 25375388
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responsible party type: Principal Investigator
investigator affiliation: Shandong University of Traditional Chinese Medicine
investigator full name: weiliang zhang
investigator title: Affiliated Hospital of Shandong University of Traditional Chinese Medicine
mesh term: Emergence Delirium
mesh term: Urinary Retention
mesh term: Thrombosis
mesh term: Venous Thrombosis
mesh term: Vomiting
mesh term: Postoperative Complications
mesh term: Postoperative Nausea and Vomiting
sharing ipd: Yes
ipd description: IPD sharing content included the intervention protocol, record or data collected for the primary and secondary outcome measures.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Data will be available within 6 months of study completion, forever.
ipd access criteria: Anyone are available to access the data collected on this website with requiring to sign the Data Access Agreement.
provided document: 
provided document: 