<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/NCT03290599</url>
  </required_header>
  <id_info>
    <org_study_id>1</org_study_id>
    <nct_id>NCT03290599</nct_id>
  </id_info>
  <brief_title>Effect of Preoperative Hospitalization Duration on Post-operative Cognitive Dysfunction</brief_title>
  <official_title>Effect of Preoperative Hospitalization Duration on Post-operative Cognitive Dysfunction in Patients Who Underwent Hip Surgery Under Regional Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Burcu Ozalp Horsanali</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kackar State Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Post-operative cognitive dysfunction is defined as a decrease in cognitive functions which&#xD;
      develop following surgery and anesthesia administration that can last up to weeks or even&#xD;
      months after surgery. In this study, our main objective was to investigate the effect of&#xD;
      preoperative hospitalisation period on early post operative cognitive dysfunction development&#xD;
      and its risk factors in patients who underwent total hip replacement surgery for hip&#xD;
      fractures under regional anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study evaluated Mini Mental Test scores of patients who received total hip replacement&#xD;
      surgery in Izmir Bozyaka Training and Research Hospital from November 2013 to September 2014.&#xD;
      In the assessment, Mini Mental Test (MMT) was used for literate and Modified Mini Mental Test&#xD;
      (MMMT) was used for illiterate patients. Test scores were obtained on the initial admission&#xD;
      day (MMT1), 24 hours prior to surgery (MMT2) and 24 hours after the surgery (MMT3). A drop of&#xD;
      4 points or more between each test was defined as significant cognitive dysfunction&#xD;
      development. Patients who did not have any change or a change less than 4 points between MMT1&#xD;
      and MMT3 were grouped as &quot;no cognitive dysfunction&quot; (Group 1) and patients with a difference&#xD;
      more than 4 points between MMT1 and MMT3 were grouped as &quot;cognitive dysfunction&quot; (Group 2).&#xD;
      All analyses were performed using those 2 patient groups.&#xD;
&#xD;
      Patients who were planned to undergo total hip replacement surgery without cement over 18&#xD;
      years of age and within ASA Group 1, 2 and 3 according to ASA physical status score were&#xD;
      included in the study.&#xD;
&#xD;
      Patients younger than 18, who did not speak Turkish, with known cancer history, previous&#xD;
      steroid treatment, SVO history in last 6 months, with central nervous system diseases&#xD;
      (current meningitis, encephalitis, tumors, major degenerative diseases), with dementia,&#xD;
      Alzheimer's and Parkinson's Disease, pregnant patients, patients with neuropsychiatric&#xD;
      diseases or received antidepressant, antipsychotic or anticonvulsive treatment in the last 6&#xD;
      months, uncooperative patients, patients with substance abuse problems, patients with severe&#xD;
      organ failure (end-stage liver failure, dialysis-dependent kidney failure), patients who&#xD;
      required ICU following surgery, patients where regional anesthesia was contraindicated&#xD;
      (Idiopathic intracranial hypertension (IIH), clotting disorders, infection on operational&#xD;
      site) were excluded from the study.&#xD;
&#xD;
      No premedication was done on patients during preoperative period. Hydration during&#xD;
      preoperative period was done by IV 0.9% NaCl aqueous solution with a fasting period of 6-10&#xD;
      hours prior to surgery.&#xD;
&#xD;
      In our study, combined spinal-epidural anesthesia was used for anesthesia for all the&#xD;
      patients. Surgical intervention was allowed on the patients with sensory block on T8&#xD;
      dermatome levels. Patients also received 0.5 mg IV bolus midazolam with Ramsey Sedation Scale&#xD;
      3.&#xD;
&#xD;
      During anesthesia, systolic blood pressure decreases more than 20% compared to preoperative&#xD;
      period was defined as hypotension. 5 mg IV Ephedrine was administered to the patients when&#xD;
      their arterial blood pressure levels stayed 50mmHg and below despite fluid replacement.&#xD;
      Bradycardia was defined as pulses below 40 bpm and was treated with 0.5 mg IV atropine.&#xD;
&#xD;
      Postoperative pain management was planned according to Visual Analogue Scale (VAS). In&#xD;
      patients with VAS score 3 and above, 10 ml isobaric bupivacaine 0.125% was administered&#xD;
      through epidural catheter. No additional medication (opiates or NSAIDs) were used for&#xD;
      analgesia.&#xD;
&#xD;
      Demographics, education levels, employment status, operation indications, ASA scores,&#xD;
      comorbid diseases and tobacco use of all patients were questioned and recorded. Scores of MMT&#xD;
      or MMMT of patients on their initial admission, 24 hours prior to surgery and 24 hours after&#xD;
      surgery and its parameters were all recorded and grouped.&#xD;
&#xD;
      The period from the initial admission to the surgery date was calculated and recorded.&#xD;
      Patients' hemoglobin, hematocrit, serum electrolyte levels on their admission, preoperative&#xD;
      and postoperative periods were recorded.&#xD;
&#xD;
      Finally, anesthesia duration, surgery duration, administered midazolam, atropine and&#xD;
      ephedrine doses, crystalloid, colloid, blood and blood products used during surgery and total&#xD;
      blood loss volume were all recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2013</start_date>
  <completion_date type="Actual">September 30, 2014</completion_date>
  <primary_completion_date type="Actual">September 30, 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Post operative Cognitive Dysfunction</measure>
    <time_frame>change of Mini mental test score from hospitalisation time to post operative 24th hour</time_frame>
    <description>Mini mental test</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">64</enrollment>
  <condition>Post Operative Cognitive Dysfunction</condition>
  <arm_group>
    <arm_group_label>No Post operative cognitive dysfunction</arm_group_label>
    <description>Patients who did not have any change or a change less than 4 points between MMT1 and MMT3</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Post operative cognitive dysfunction</arm_group_label>
    <description>Patients with a difference more than 4 points between MMT1 and MMT3</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mini Mental and Modified Mini Mental Test</intervention_name>
    <description>Mini Mental Test was used for literate patients and Modified mini mental test was used for illiterated patients</description>
    <arm_group_label>No Post operative cognitive dysfunction</arm_group_label>
    <arm_group_label>Post operative cognitive dysfunction</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who underwent total hip replacement surgery over 18 aged&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who were planned to undergo total hip replacement surgery without cement over&#xD;
             18 years of age and within ASA Group 1, 2 and 3 according to ASA physical status score&#xD;
             were included in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients younger than 18, who did not speak Turkish, with known cancer history,&#xD;
             previous steroid treatment, SVO history in last 6 months, with central nervous system&#xD;
             diseases (current meningitis, encephalitis, tumors, major degenerative diseases), with&#xD;
             dementia, Alzheimer's and Parkinson's Disease, pregnant patients, patients with&#xD;
             neuropsychiatric diseases or received antidepressant, antipsychotic or anticonvulsive&#xD;
             treatment in the last 6 months, uncooperative patients, patients with substance abuse&#xD;
             problems, patients with severe organ failure (end-stage liver failure,&#xD;
             dialysis-dependent kidney failure), patients who required ICU following surgery,&#xD;
             patients where regional anesthesia was contraindicated (Idiopathic intracranial&#xD;
             hypertension (IIH), clotting disorders, infection on operational site) were excluded&#xD;
             from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 17, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>September 20, 2017</last_update_submitted>
  <last_update_submitted_qc>September 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Kackar State Hospital</investigator_affiliation>
    <investigator_full_name>Burcu Ozalp Horsanali</investigator_full_name>
    <investigator_title>Burcu OZALP HORSANALI</investigator_title>
  </responsible_party>
  <keyword>Cognitive dysfunction</keyword>
  <keyword>Hip Surgery</keyword>
  <keyword>Mini mental Test,</keyword>
  <keyword>Preoperative Hospitalisation</keyword>
  <keyword>Spinal Anesthesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Cognitive Complications</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03290599
org study id: 1
nct id: NCT03290599
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Post-operative cognitive dysfunction is defined as a decrease in cognitive functions which
      develop following surgery and anesthesia administration that can last up to weeks or even
      months after surgery. In this study, our main objective was to investigate the effect of
      preoperative hospitalisation period on early post operative cognitive dysfunction development
      and its risk factors in patients who underwent total hip replacement surgery for hip
      fractures under regional anesthesia.
The study evaluated Mini Mental Test scores of patients who received total hip replacement
      surgery in Izmir Bozyaka Training and Research Hospital from November 2013 to September 2014.
      In the assessment, Mini Mental Test (MMT) was used for literate and Modified Mini Mental Test
      (MMMT) was used for illiterate patients. Test scores were obtained on the initial admission
      day (MMT1), 24 hours prior to surgery (MMT2) and 24 hours after the surgery (MMT3). A drop of
      4 points or more between each test was defined as significant cognitive dysfunction
      development. Patients who did not have any change or a change less than 4 points between MMT1
      and MMT3 were grouped as "no cognitive dysfunction" (Group 1) and patients with a difference
      more than 4 points between MMT1 and MMT3 were grouped as "cognitive dysfunction" (Group 2).
      All analyses were performed using those 2 patient groups.

      Patients who were planned to undergo total hip replacement surgery without cement over 18
      years of age and within ASA Group 1, 2 and 3 according to ASA physical status score were
      included in the study.

      Patients younger than 18, who did not speak Turkish, with known cancer history, previous
      steroid treatment, SVO history in last 6 months, with central nervous system diseases
      (current meningitis, encephalitis, tumors, major degenerative diseases), with dementia,
      Alzheimer's and Parkinson's Disease, pregnant patients, patients with neuropsychiatric
      diseases or received antidepressant, antipsychotic or anticonvulsive treatment in the last 6
      months, uncooperative patients, patients with substance abuse problems, patients with severe
      organ failure (end-stage liver failure, dialysis-dependent kidney failure), patients who
      required ICU following surgery, patients where regional anesthesia was contraindicated
      (Idiopathic intracranial hypertension (IIH), clotting disorders, infection on operational
      site) were excluded from the study.

      No premedication was done on patients during preoperative period. Hydration during
      preoperative period was done by IV 0.9% NaCl aqueous solution with a fasting period of 6-10
      hours prior to surgery.

      In our study, combined spinal-epidural anesthesia was used for anesthesia for all the
      patients. Surgical intervention was allowed on the patients with sensory block on T8
      dermatome levels. Patients also received 0.5 mg IV bolus midazolam with Ramsey Sedation Scale
      3.

      During anesthesia, systolic blood pressure decreases more than 20% compared to preoperative
      period was defined as hypotension. 5 mg IV Ephedrine was administered to the patients when
      their arterial blood pressure levels stayed 50mmHg and below despite fluid replacement.
      Bradycardia was defined as pulses below 40 bpm and was treated with 0.5 mg IV atropine.

      Postoperative pain management was planned according to Visual Analogue Scale (VAS). In
      patients with VAS score 3 and above, 10 ml isobaric bupivacaine 0.125% was administered
      through epidural catheter. No additional medication (opiates or NSAIDs) were used for
      analgesia.

      Demographics, education levels, employment status, operation indications, ASA scores,
      comorbid diseases and tobacco use of all patients were questioned and recorded. Scores of MMT
      or MMMT of patients on their initial admission, 24 hours prior to surgery and 24 hours after
      surgery and its parameters were all recorded and grouped.

      The period from the initial admission to the surgery date was calculated and recorded.
      Patients' hemoglobin, hematocrit, serum electrolyte levels on their admission, preoperative
      and postoperative periods were recorded.

      Finally, anesthesia duration, surgery duration, administered midazolam, atropine and
      ephedrine doses, crystalloid, colloid, blood and blood products used during surgery and total
      blood loss volume were all recorded.
observational model: Other
time perspective: Prospective
measure: Post operative Cognitive Dysfunction
time frame: change of Mini mental test score from hospitalisation time to post operative 24th hour
description: Mini mental test
arm group label: No Post operative cognitive dysfunction
description: Patients who did not have any change or a change less than 4 points between MMT1 and MMT3
arm group label: Post operative cognitive dysfunction
description: Patients with a difference more than 4 points between MMT1 and MMT3
intervention type: Other
intervention name: Mini Mental and Modified Mini Mental Test
description: Mini Mental Test was used for literate patients and Modified mini mental test was used for illiterated patients
arm group label: No Post operative cognitive dysfunction
arm group label: Post operative cognitive dysfunction
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor-Investigator
investigator affiliation: Kackar State Hospital
investigator full name: Burcu Ozalp Horsanali
investigator title: Burcu OZALP HORSANALI
mesh term: Postoperative Cognitive Complications
mesh term: Cognitive Dysfunction
sharing ipd: No