<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/NCT03818009</url>
  </required_header>
  <id_info>
    <org_study_id>Beni-Suef 17</org_study_id>
    <nct_id>NCT03818009</nct_id>
  </id_info>
  <brief_title>Effect of General Anesthesia on Early Postoperative Cognitive Function in Cesarean Section</brief_title>
  <official_title>Effect of General Anesthesia on Early Postoperative Cognitive Dysfunction in Elective Versus Emergency Cesarean Section</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beni-Suef University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beni-Suef University</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>
      Cognitive dysfunction is the impairment of the mental process of perception, memory and&#xD;
      information processing. The preoperative cognitive state is important, as mild cognitive&#xD;
      impairment may be worsened following a cesarean section. Our study will aim to assess the&#xD;
      incidence of early cognitive dysfunction after elective and emergent cesarean section under&#xD;
      general anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Mechanisms that lead to cognitive decline after anesthesia and surgery remain still unclear&#xD;
      and mixed. Some studies suggested that an important role is played by the immune response to&#xD;
      surgery. The inflammatory response could contribute to the development of postoperative&#xD;
      cognitive decline (POCD0 through secretion of cortisol, cytokines, and other inflammatory&#xD;
      mediators. Comparing the effects of general and spinal anesthesia on pregnant patients&#xD;
      undergoing an elective cesarean section, found no cognitive change after both anesthesias.&#xD;
      Our observational comparative study will be carried out at Beni Suef University Hospital. We&#xD;
      will compare early cognitive functions undergoing general anesthesia in patients undergoing&#xD;
      elective and emergency cesarean section.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 14, 2019</start_date>
  <completion_date type="Actual">September 20, 2020</completion_date>
  <primary_completion_date type="Actual">September 20, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative cognitive decline (POCD)</measure>
    <time_frame>3 hours postoperative</time_frame>
    <description>New impairment of memory directly post operative which will be assessed by psychometric questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>impaired performance on intellectual tasks</measure>
    <time_frame>3 days postoperative</time_frame>
    <description>New impairment of using mind in daily tasks directly post operative which will be assessed through a questionnaire</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">58</enrollment>
  <condition>Anesthesia Morbidity</condition>
  <condition>Cesarean Section Complications</condition>
  <arm_group>
    <arm_group_label>women undergoing elective CS under general anesthesia</arm_group_label>
    <description>Early postoperative assessment of the cognitive function of patients through evaluation document which will be filled by the anesthesiologist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>women undergoing emergency CS under general anesthesia</arm_group_label>
    <description>Early postoperative assessment of the cognitive function of patients through evaluation document which will be filled by the anesthesiologist.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Assessment document</intervention_name>
    <description>The anesthesiologist will evaluate through his sheet women's cognitive functions.</description>
    <arm_group_label>women undergoing elective CS under general anesthesia</arm_group_label>
    <arm_group_label>women undergoing emergency CS under general anesthesia</arm_group_label>
    <other_name>Anesthesiologist evaluation sheet</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women in reproductive age period between 25 and 35 years booked for an elective or&#xD;
        emergency cesarean section.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women in reproductive age period between 25 and 35 years&#xD;
&#xD;
          -  Women booked for an elective or emergency cesarean section.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mental disorder preoperative&#xD;
&#xD;
          -  Medical conditions ( as Hypertension or diabetes or cardiac diseases)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nesreen Abdel Fattah Abdullah Shehata</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <results_reference>
    <citation>Rasmussen LS, O'Brien JT, Silverstein JH, Johnson TW, Siersma VD, Canet J, Jolles J, Hanning CD, Kuipers HM, Abildstrom H, Papaioannou A, Raeder J, Yli-Hankala A, Sneyd JR, Munoz L, Moller JT; ISPOCD2 Investigators. Is peri-operative cortisol secretion related to post-operative cognitive dysfunction? Acta Anaesthesiol Scand. 2005 Oct;49(9):1225-31. doi: 10.1111/j.1399-6576.2005.00791.x.</citation>
    <PMID>16146456</PMID>
  </results_reference>
  <results_reference>
    <citation>Wan Y, Xu J, Ma D, Zeng Y, Cibelli M, Maze M. Postoperative impairment of cognitive function in rats: a possible role for cytokine-mediated inflammation in the hippocampus. Anesthesiology. 2007 Mar;106(3):436-43. doi: 10.1097/00000542-200703000-00007.</citation>
    <PMID>17325501</PMID>
  </results_reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>January 20, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>November 16, 2020</last_update_submitted>
  <last_update_submitted_qc>November 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beni-Suef University</investigator_affiliation>
    <investigator_full_name>Nesreen Abdel Fattah Abdullah Shehata</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>Cognitive function postoperative</keyword>
  <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/NCT03818009
org study id: Beni-Suef 17
nct id: NCT03818009
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cognitive dysfunction is the impairment of the mental process of perception, memory and
      information processing. The preoperative cognitive state is important, as mild cognitive
      impairment may be worsened following a cesarean section. Our study will aim to assess the
      incidence of early cognitive dysfunction after elective and emergent cesarean section under
      general anesthesia.
Mechanisms that lead to cognitive decline after anesthesia and surgery remain still unclear
      and mixed. Some studies suggested that an important role is played by the immune response to
      surgery. The inflammatory response could contribute to the development of postoperative
      cognitive decline (POCD0 through secretion of cortisol, cytokines, and other inflammatory
      mediators. Comparing the effects of general and spinal anesthesia on pregnant patients
      undergoing an elective cesarean section, found no cognitive change after both anesthesias.
      Our observational comparative study will be carried out at Beni Suef University Hospital. We
      will compare early cognitive functions undergoing general anesthesia in patients undergoing
      elective and emergency cesarean section.
observational model: Cohort
time perspective: Prospective
measure: postoperative cognitive decline (POCD)
time frame: 3 hours postoperative
description: New impairment of memory directly post operative which will be assessed by psychometric questionnaire
measure: impaired performance on intellectual tasks
time frame: 3 days postoperative
description: New impairment of using mind in daily tasks directly post operative which will be assessed through a questionnaire
arm group label: women undergoing elective CS under general anesthesia
description: Early postoperative assessment of the cognitive function of patients through evaluation document which will be filled by the anesthesiologist.
arm group label: women undergoing emergency CS under general anesthesia
description: Early postoperative assessment of the cognitive function of patients through evaluation document which will be filled by the anesthesiologist.
intervention type: Other
intervention name: Assessment document
description: The anesthesiologist will evaluate through his sheet women's cognitive functions.
arm group label: women undergoing elective CS under general anesthesia
arm group label: women undergoing emergency CS under general anesthesia
other name: Anesthesiologist evaluation sheet
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 25 Years
maximum age: 35 Years
healthy volunteers: No
facility: 
country: Egypt
citation: Rasmussen LS, O'Brien JT, Silverstein JH, Johnson TW, Siersma VD, Canet J, Jolles J, Hanning CD, Kuipers HM, Abildstrom H, Papaioannou A, Raeder J, Yli-Hankala A, Sneyd JR, Munoz L, Moller JT; ISPOCD2 Investigators. Is peri-operative cortisol secretion related to post-operative cognitive dysfunction? Acta Anaesthesiol Scand. 2005 Oct;49(9):1225-31. doi: 10.1111/j.1399-6576.2005.00791.x.
PMID: 16146456
citation: Wan Y, Xu J, Ma D, Zeng Y, Cibelli M, Maze M. Postoperative impairment of cognitive function in rats: a possible role for cytokine-mediated inflammation in the hippocampus. Anesthesiology. 2007 Mar;106(3):436-43. doi: 10.1097/00000542-200703000-00007.
PMID: 17325501
responsible party type: Principal Investigator
investigator affiliation: Beni-Suef University
investigator full name: Nesreen Abdel Fattah Abdullah Shehata
investigator title: Assistant professor
sharing ipd: No