xml: <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/NCT05970055</url>
    </required_header>
    <id_info>
      <org_study_id>WolloU</org_study_id>
      <nct_id>NCT05970055</nct_id>
    </id_info>
    <brief_title>Prevalence and Associated Factors of Post-operative Nausea and Vomiting</brief_title>
    <official_title>Prevalence and Associated Factors of Post-operative Nausea and Vomiting Among Adult Patients Undergoing Elective Surgery in DCSH, Dessie, Northeast Ethiopia, 2022</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sara Timerga</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Wollo 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>
        Postoperative nausea and vomiting (PONV) is a surgical complication defined as any nausea,&#xD;
        and vomiting with in the first 24-48 hours after surgery in inpatients. Nausea is an&#xD;
        unpleasant feeling or desire to vomit without expulsive muscular movement, while vomiting is&#xD;
        a forceful expulsion or reflux of the gastric contents through the mouth. Postoperative&#xD;
        nausea and vomiting is one of the most common complication associated anesthesia and surgery.&#xD;
        It is considered the most common cause of morbidity, and it has significant effects on&#xD;
        patient satisfaction. In spite of recent development of anesthesia and surgical techniques,&#xD;
        the incidence of PONV remains high. This common anesthetic and surgical side effect has been&#xD;
        reported to increase patient dissatisfaction and can be just as distressing to patients as&#xD;
        postoperative pain is.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Postoperative nausea and vomiting is caused by multiple factors; patient related, anesthesia&#xD;
        and surgery related risk factors have been identified. Patient related factors include female&#xD;
        gender post-puberty, nonsmoking status, history of PONV or motion sickness, and childhood&#xD;
        after infancy and younger adulthood. Use of volatile anesthetics, nitrous oxide, large-dose&#xD;
        neostigmine, or intraoperative or postoperative opioids are factors related to anesthesia,&#xD;
        while the type of procedures like gynecologic, ophthalmological, ontological, thyroid surgery&#xD;
        laparoscopic, abdominal surgery and duration of the procedure are some of surgery related&#xD;
        risk factors.&#xD;
  &#xD;
        The incidence of PONV for over multiple individual studies conducted around the world, has&#xD;
        been estimated to be 25% to 30% and up to 80% in high risk groups. The incidence of PONV is&#xD;
        estimated to range from 20%-36%.&#xD;
  &#xD;
        Post-operative nausea and vomiting imposes multiple impacts on patients. The main one being a&#xD;
        decrease satisfaction, but more importantly it leads to dehydration, electrolyte imbalance,&#xD;
        aspiration of gastric secretions, esophageal rupture, bleeding, increased morbidity, and&#xD;
        delayed discharge from hospital.&#xD;
  &#xD;
        The study aimed to assess the incidence and associated factors of post-operative nausea and&#xD;
        vomiting, which is believed to be a main contributing factor to dissatisfaction and delayed&#xD;
        recovery seen in our country. The study was done from February to April 2022 in patients&#xD;
        undergoing elective surgery at Dessie comprehensive specialized hospital, Ethiopia.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 1, 2022</start_date>
    <completion_date type="Actual">July 30, 2022</completion_date>
    <primary_completion_date type="Actual">April 30, 2022</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>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>post-operative nausea and vomiting</measure>
      <time_frame>24 hours</time_frame>
      <description>Postoperative nausea and vomiting (PONV) is defined as any nausea, retching, or vomiting occurring during the first 24-48 h after surgery.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">677</enrollment>
    <condition>Postoperative Nausea and Vomiting</condition>
    <arm_group>
      <arm_group_label>PONV and Non PONV</arm_group_label>
      <description>PONV- patients who developed nausea and vomiting postoperatively Non PONV- patients who did not develop nausea and vomiting postoperatively</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>elective surgery</intervention_name>
      <description>All elective surgical procedures performed under the study period will be included.</description>
      <arm_group_label>PONV and Non PONV</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          All adult, elective patients who underwent elective surgery under anesthesia at the Dessie&#xD;
          comprehensive specialized hospital during the study period&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All adult patients, who underwent elective surgery under anesthesia in the study&#xD;
               period.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who didn't gain their consciousness postoperatively, patients who underwent&#xD;
               emergency surgery, patients who were re-operated on during the study period, surgical&#xD;
               patients medical illness that predispose them to nausea and vomiting, and patients&#xD;
               discharged before 24 hours postoperatively&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Sara Timerga</last_name>
      <role>Principal Investigator</role>
      <affiliation>Wollo University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Wollo Univeersity</name>
        <address>
          <city>Dessie</city>
          <zip>1145</zip>
          <country>Ethiopia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Ethiopia</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 23, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 23, 2023</last_update_submitted>
    <last_update_submitted_qc>July 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Wollo University</investigator_affiliation>
      <investigator_full_name>Sara Timerga</investigator_full_name>
      <investigator_title>Lecturer</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Nausea</mesh_term>
      <mesh_term>Vomiting</mesh_term>
      <mesh_term>Postoperative Nausea and Vomiting</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>The plan to share IPD will depend on the requests.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05970055
  org study id: WolloU
  nct id: NCT05970055
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Postoperative nausea and vomiting (PONV) is a surgical complication defined as any nausea,
        and vomiting with in the first 24-48 hours after surgery in inpatients. Nausea is an
        unpleasant feeling or desire to vomit without expulsive muscular movement, while vomiting is
        a forceful expulsion or reflux of the gastric contents through the mouth. Postoperative
        nausea and vomiting is one of the most common complication associated anesthesia and surgery.
        It is considered the most common cause of morbidity, and it has significant effects on
        patient satisfaction. In spite of recent development of anesthesia and surgical techniques,
        the incidence of PONV remains high. This common anesthetic and surgical side effect has been
        reported to increase patient dissatisfaction and can be just as distressing to patients as
        postoperative pain is.
  Postoperative nausea and vomiting is caused by multiple factors; patient related, anesthesia
        and surgery related risk factors have been identified. Patient related factors include female
        gender post-puberty, nonsmoking status, history of PONV or motion sickness, and childhood
        after infancy and younger adulthood. Use of volatile anesthetics, nitrous oxide, large-dose
        neostigmine, or intraoperative or postoperative opioids are factors related to anesthesia,
        while the type of procedures like gynecologic, ophthalmological, ontological, thyroid surgery
        laparoscopic, abdominal surgery and duration of the procedure are some of surgery related
        risk factors.
  
        The incidence of PONV for over multiple individual studies conducted around the world, has
        been estimated to be 25% to 30% and up to 80% in high risk groups. The incidence of PONV is
        estimated to range from 20%-36%.
  
        Post-operative nausea and vomiting imposes multiple impacts on patients. The main one being a
        decrease satisfaction, but more importantly it leads to dehydration, electrolyte imbalance,
        aspiration of gastric secretions, esophageal rupture, bleeding, increased morbidity, and
        delayed discharge from hospital.
  
        The study aimed to assess the incidence and associated factors of post-operative nausea and
        vomiting, which is believed to be a main contributing factor to dissatisfaction and delayed
        recovery seen in our country. The study was done from February to April 2022 in patients
        undergoing elective surgery at Dessie comprehensive specialized hospital, Ethiopia.
  observational model: Other
  time perspective: Cross-Sectional
  measure: post-operative nausea and vomiting
  time frame: 24 hours
  description: Postoperative nausea and vomiting (PONV) is defined as any nausea, retching, or vomiting occurring during the first 24-48 h after surgery.
  arm group label: PONV and Non PONV
  description: PONV- patients who developed nausea and vomiting postoperatively Non PONV- patients who did not develop nausea and vomiting postoperatively
  intervention type: Procedure
  intervention name: elective surgery
  description: All elective surgical procedures performed under the study period will be included.
  arm group label: PONV and Non PONV
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Sara Timerga
  role: Principal Investigator
  affiliation: Wollo University
  facility: 
  country: Ethiopia
  responsible party type: Sponsor-Investigator
  investigator affiliation: Wollo University
  investigator full name: Sara Timerga
  investigator title: Lecturer
  mesh term: Nausea
  mesh term: Vomiting
  mesh term: Postoperative Nausea and Vomiting
  sharing ipd: Undecided
  ipd description: The plan to share IPD will depend on the requests.