<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/NCT04438915</url>
  </required_header>
  <id_info>
    <org_study_id>FMBSUREC/03052020/Bahr</org_study_id>
    <nct_id>NCT04438915</nct_id>
  </id_info>
  <brief_title>The Effect of Obesity on the Incidence of Postoperative Cognitive Dysfunction in Gynecological Day Case Surgery</brief_title>
  <official_title>The Effect of Obesity on the Incidence of Postoperative Cognitive Dysfunction in Gynecological Day-case Surgery</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>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>
      Cognitive dysfunction is the impairment of mental process of perception. memory and&#xD;
      information processing which allow the human to acquire knowledge and plan for the future.&#xD;
      The etiology of Post operative cognitive dysfunction (POCD) is unclear and seems to be&#xD;
      multifactorial involving a combination of patient, surgical, anesthetic and environmental&#xD;
      factors. The definition of day surgery in Great Britain and Ireland is clear; the patient is&#xD;
      admitted and discharged on the same day.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cognitive dysfunction is the impairment of mental process of perception. memory and&#xD;
      information processing which allow the human to acquire knowledge and plan for the future.&#xD;
      The etiology of Post operative cognitive dysfunction (POCD) is unclear and seems to be&#xD;
      multifactorial involving a combination of patient, surgical, anesthetic and environmental&#xD;
      factors. It can be a manifestation of transient or permanent cerebral injury. While cognitive&#xD;
      function tends to improve overmonths to years postoperatively in affected individuals, some&#xD;
      proportion has seemingly permanent cognitive injury. Most of the studies of POCD, however,&#xD;
      have methodological difficulties, as pointed out by Newman and colleagues in their review of&#xD;
      more than 40 studies.&#xD;
&#xD;
      The overweight/obese population has been steadily increasing worldwide. According to the WHO,&#xD;
      with1.3 billion overweight (25 &lt; body mass index [BMI] &lt; 30) people and 600 million obese&#xD;
      (BMI &gt; 30) people in the world, the obesity rate exceeds10% for both genders and has more&#xD;
      than doubled during the past 40 years. Furthermore, It considered as seven of the top10&#xD;
      causes of death / physical disability and chronic disorders such as cancer and diabetes,&#xD;
      which are closely related to obesity.&#xD;
&#xD;
      The definition of day surgery in Great Britain and Ireland is clear; the patient is admitted&#xD;
      and discharged on the same day, with day surgery as the intended management. The term '23-h&#xD;
      stay' is used in the United states healthcare system. Obesity itself is not a&#xD;
      contraindication to day surgery, as morbidly obese patients can be safely managed by experts,&#xD;
      provided appropriate resources are available. This includes factoring in additional time for&#xD;
      anaesthesia and surgery as well as the presence of skilled assistants and equipment.&#xD;
&#xD;
      The incidence of complications during the operation or in the early recovery phase is greater&#xD;
      in patients with increasing body mass index. However, these problems would still occur with&#xD;
      inpatient care and have usually resolved or been successfully treated by the time a day-case&#xD;
      patient would be discharged. In addition, obese patients benefit from short-duration&#xD;
      anaesthetic techniques and early mobilisation associated with day surgery.&#xD;
&#xD;
      Our study will aim to assess the early cognitive dysfunction after general anesthesia in&#xD;
      normal weight patients, overweight and mild obese patients in gynacological day-case surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2020</start_date>
  <completion_date type="Actual">May 20, 2021</completion_date>
  <primary_completion_date type="Actual">May 20, 2021</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>Diagnostic</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>The doctor who ask the MMS is not informed about the design of the study .</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative cognitive dysfunction( POCD )</measure>
    <time_frame>1 hour Preoperative _ then 1 hour , 6 hours and 24 hour postoperatively</time_frame>
    <description>Mini Mental State a practical method for grading the cognitive state ( Max score 30 degree ) Orientation 10 degree , Registration 3 degree , Attention&amp;Calculation 5 degree , Recall 3 degree , language 9 degree .&#xD;
Decrease 2 or more than Preoperative score will indicate POCD.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>weight ln kilograms (KG ) and Height in meters (M ) will be combined to report Body mass index (BMI ) . BMI = KG/ M^2 .</measure>
    <time_frame>Preoperative.</time_frame>
    <description>To show the effect of obesity on POCD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital signs: HR (beat/min), MAP (mmHg) and peripheral Oxygen saturation (Spo2) %</measure>
    <time_frame>immediately prior to induction of anesthesia and subsequently every 5 min till the termination of anesthesia.</time_frame>
    <description>To make other factors irrelevant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of surgery in minutes</measure>
    <time_frame>Intraoperative</time_frame>
    <description>To make other factors irrelevant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AGE in years</measure>
    <time_frame>Preoperative</time_frame>
    <description>To make other factors irrelevant</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">138</enrollment>
  <condition>Postoperative Cognitive Dysfunction</condition>
  <arm_group>
    <arm_group_label>Average weight .control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Average weight BMI (18.5_25)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Overweight</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Overweight BMI ( 25_30 )</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mild obese</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mild obese BMI (30_35 )</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Effect of Obesity on incidence of Postoperative cognitive in Gynecological Day- Day- case surgery</intervention_name>
    <description>The effect of obesity on the incidence of postoperative cognitive dysfunction in Gynecological day-case surgery</description>
    <arm_group_label>Mild obese</arm_group_label>
    <arm_group_label>Overweight</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aging 20_40 years, ASA physical status I undergoing hysteroscopy procedures&#xD;
&#xD;
          -  All patients can read and write well&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients not ASA1 Patients receiving sedatives as midazolam. Pregnant Patients . Patients&#xD;
        with cerebrovascular diseases . Patients with history of allergy to the drugs used in the&#xD;
        study or patients with substance abuse .&#xD;
&#xD;
        Time of anesthesia less than 30 minute ,or more than one hour . Irrigation fluid rather&#xD;
        than warm saline(40 degree ) or fluid volume more than 1500 ml&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Gynecological Day- case surgery</gender_description>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amira F Elgaml</last_name>
    <role>Study Director</role>
    <affiliation>Faculty of medicine.Beni-suef university</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of medicine.Beni-suef university</name>
      <address>
        <city>Cairo</city>
        <zip>11865</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>June 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>July 19, 2021</last_update_submitted>
  <last_update_submitted_qc>July 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beni-Suef University</investigator_affiliation>
    <investigator_full_name>Mahmoud Hussein Bahr</investigator_full_name>
    <investigator_title>Lecturer in Anaesthesia , Surgical ICU and Pain management department . Faculty of medicine .</investigator_title>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Day-case Surgery</keyword>
  <keyword>Postoperative cognitive dysfunction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Postoperative Cognitive Complications</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The effect of obesity on the incidence of postoperative cognitive dysfunction in Gynecological Day- case surgery</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>6 months</ipd_time_frame>
    <ipd_access_criteria>The effect of obesity on the incidence of postoperative cognitive dysfunction in Gynecological Day- case surgery</ipd_access_criteria>
    <ipd_url>http://www.bsu.edu.eg</ipd_url>
  </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/NCT04438915
org study id: FMBSUREC/03052020/Bahr
nct id: NCT04438915
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Cognitive dysfunction is the impairment of mental process of perception. memory and
      information processing which allow the human to acquire knowledge and plan for the future.
      The etiology of Post operative cognitive dysfunction (POCD) is unclear and seems to be
      multifactorial involving a combination of patient, surgical, anesthetic and environmental
      factors. The definition of day surgery in Great Britain and Ireland is clear; the patient is
      admitted and discharged on the same day.
Cognitive dysfunction is the impairment of mental process of perception. memory and
      information processing which allow the human to acquire knowledge and plan for the future.
      The etiology of Post operative cognitive dysfunction (POCD) is unclear and seems to be
      multifactorial involving a combination of patient, surgical, anesthetic and environmental
      factors. It can be a manifestation of transient or permanent cerebral injury. While cognitive
      function tends to improve overmonths to years postoperatively in affected individuals, some
      proportion has seemingly permanent cognitive injury. Most of the studies of POCD, however,
      have methodological difficulties, as pointed out by Newman and colleagues in their review of
      more than 40 studies.

      The overweight/obese population has been steadily increasing worldwide. According to the WHO,
      with1.3 billion overweight (25 < body mass index [BMI] < 30) people and 600 million obese
      (BMI > 30) people in the world, the obesity rate exceeds10% for both genders and has more
      than doubled during the past 40 years. Furthermore, It considered as seven of the top10
      causes of death / physical disability and chronic disorders such as cancer and diabetes,
      which are closely related to obesity.

      The definition of day surgery in Great Britain and Ireland is clear; the patient is admitted
      and discharged on the same day, with day surgery as the intended management. The term '23-h
      stay' is used in the United states healthcare system. Obesity itself is not a
      contraindication to day surgery, as morbidly obese patients can be safely managed by experts,
      provided appropriate resources are available. This includes factoring in additional time for
      anaesthesia and surgery as well as the presence of skilled assistants and equipment.

      The incidence of complications during the operation or in the early recovery phase is greater
      in patients with increasing body mass index. However, these problems would still occur with
      inpatient care and have usually resolved or been successfully treated by the time a day-case
      patient would be discharged. In addition, obese patients benefit from short-duration
      anaesthetic techniques and early mobilisation associated with day surgery.

      Our study will aim to assess the early cognitive dysfunction after general anesthesia in
      normal weight patients, overweight and mild obese patients in gynacological day-case surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Investigator)
masking description: The doctor who ask the MMS is not informed about the design of the study .
measure: Postoperative cognitive dysfunction( POCD )
time frame: 1 hour Preoperative _ then 1 hour , 6 hours and 24 hour postoperatively
description: Mini Mental State a practical method for grading the cognitive state ( Max score 30 degree ) Orientation 10 degree , Registration 3 degree , Attention&Calculation 5 degree , Recall 3 degree , language 9 degree .
Decrease 2 or more than Preoperative score will indicate POCD.
measure: weight ln kilograms (KG ) and Height in meters (M ) will be combined to report Body mass index (BMI ) . BMI = KG/ M^2 .
time frame: Preoperative.
description: To show the effect of obesity on POCD
measure: Vital signs: HR (beat/min), MAP (mmHg) and peripheral Oxygen saturation (Spo2) %
time frame: immediately prior to induction of anesthesia and subsequently every 5 min till the termination of anesthesia.
description: To make other factors irrelevant
measure: Time of surgery in minutes
time frame: Intraoperative
description: To make other factors irrelevant
measure: AGE in years
time frame: Preoperative
description: To make other factors irrelevant
arm group label: Average weight .control group
arm group type: No Intervention
description: Average weight BMI (18.5_25)
arm group label: Overweight
arm group type: Active Comparator
description: Overweight BMI ( 25_30 )
arm group label: Mild obese
arm group type: Active Comparator
description: Mild obese BMI (30_35 )
intervention type: Behavioral
intervention name: Effect of Obesity on incidence of Postoperative cognitive in Gynecological Day- Day- case surgery
description: The effect of obesity on the incidence of postoperative cognitive dysfunction in Gynecological day-case surgery
arm group label: Mild obese
arm group label: Overweight
criteria: 
gender: Female
gender based: Yes
gender description: Gynecological Day- case surgery
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: No
last name: Amira F Elgaml
role: Study Director
affiliation: Faculty of medicine.Beni-suef university
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Beni-Suef University
investigator full name: Mahmoud Hussein Bahr
investigator title: Lecturer in Anaesthesia , Surgical ICU and Pain management department . Faculty of medicine .
mesh term: Obesity
mesh term: Postoperative Cognitive Complications
mesh term: Cognitive Dysfunction
sharing ipd: Yes
ipd description: The effect of obesity on the incidence of postoperative cognitive dysfunction in Gynecological Day- case surgery
ipd info type: Study Protocol
ipd time frame: 6 months
ipd access criteria: The effect of obesity on the incidence of postoperative cognitive dysfunction in Gynecological Day- case surgery
ipd url: http://www.bsu.edu.eg