<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/NCT04411069</url>
  </required_header>
  <id_info>
    <org_study_id>NP 1336/18</org_study_id>
    <nct_id>NCT04411069</nct_id>
  </id_info>
  <brief_title>Simplified Algorithm for the Prevention of Postoperative Nausea and Vomiting in an Oncological Hospital</brief_title>
  <official_title>Simplified Algorithm for the Prevention of Postoperative Nausea and Vomiting in an Oncological Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto do Cancer do Estado de São Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto do Cancer do Estado de São Paulo</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>
      Previous history of nausea and vomiting induced by prior chemotherapy still not included as&#xD;
      predictive factor of postoperative nausea and vomiting, although has been demonstrated that&#xD;
      has influence in postoperative outcome.&#xD;
&#xD;
      The project aims to evaluate the efficacy of a simplified algorithm in prevention&#xD;
      postoperative nausea and vomiting , with pacients with previous history of nausea and&#xD;
      vomiting induced by prior chemotherapy, submitted to medium or large surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Quasi-experimental study, with evaluation after the application of a specific postoperative&#xD;
      nausea and vomiting prevention algorithm for cancer patients.&#xD;
&#xD;
      The study will be carried out in 2 phases:&#xD;
&#xD;
      Phase 1: Team training. In this phase, a protocol was established for PONV prophylaxis, using&#xD;
      two questions:&#xD;
&#xD;
        1. Patient undergoing chemotherapy before surgery;&#xD;
&#xD;
        2. Patient presented chemotherapy induced nausea and vomiting (CINV).&#xD;
&#xD;
      If the answer is yes to both questions, the anesthetist administers 3 antiemetics (4mg&#xD;
      dexametasone, 4mg ondansetron and 0,625mg droperidol). If the answer is no to one of the&#xD;
      questions, the anesthetist administers 2 antiemetics (4mg dexametasone and 4mg ondansetron);&#xD;
      In this phase, educational measures will be implemented by team meetings and individual&#xD;
      approach of all anesthesiologists at ICESP to present the study project and the algorithm. A&#xD;
      summary of the the study will be sent daily through the social network Whats App®.&#xD;
&#xD;
      The number of patients was calculated taking into account adherence to the new prophylaxis&#xD;
      protocol for post-operative nausea and vomiting. If we consider an alpha error of 5% and test&#xD;
      power of 80%, to have a NVPO reduction of 41% (current overall incidence) to 25% (incidence&#xD;
      after protocol adherence) in high-risk patients, we need to study 270 patients (135 each&#xD;
      group adherence and non-adherence to the protocol).&#xD;
&#xD;
      Phase 2: Post-training assessment. In the second phase of the study, after the end of the&#xD;
      dissemination of the protocol among doctors, the patients will be evaluated on the first&#xD;
      postoperative day. The following variables were analyzed: sex, race, age, body mass index,&#xD;
      general state of American Society of Anesthesiologist, Apfel scale, type of surgery and&#xD;
      anesthesia, use and type of opioids, history of chemotherapy induced nausea and vomiting,&#xD;
      type of antiemetics used in the operating room and in the first postoperative day, duration&#xD;
      of anesthesia and surgery and nausea and vomiting in 6 and 24 hours after surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 20, 2019</start_date>
  <completion_date type="Actual">March 20, 2021</completion_date>
  <primary_completion_date type="Actual">March 20, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>The patient didn't know if he received the third anti emetic</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative nausea and vomiting</measure>
    <time_frame>from 0 to 24 postoperative hours</time_frame>
    <description>record of any episode of nausea and or vomiting in the 24 postoperative hours</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changing in the institutional protocol</measure>
    <time_frame>from the begining to the study to the end of the study (2 years)</time_frame>
    <description>number of patients with chemotherapy-induced nausea and vomiting that received 3 antiemetics in the operating room</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">270</enrollment>
  <condition>Postoperative Nausea</condition>
  <condition>Postoperative Vomiting</condition>
  <arm_group>
    <arm_group_label>Patients without previous CINV</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients who didn't have chemotherapy or that didn´t have any nausea and/or vomiting induced by chemotherapy (CINV) before surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with previous CINV</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients who had previous nausea and vomiting induced by chemoterapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Droperidol</intervention_name>
    <description>Pacients who had nausea and vomiting induced by chemotherapy will receive three anti emetic drugs: 4mg dexametasone, 4 mg ondansetron and 0,625 mg droperidol</description>
    <arm_group_label>Patients with previous CINV</arm_group_label>
    <other_name>Intravenous droperidol</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients who underwent medium to large surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are unable to communicate (orotracheal intubation after the surgery,&#xD;
             confusion or agitation) or understand the Portuguese language;&#xD;
&#xD;
          -  Insulin dependent patients&#xD;
&#xD;
          -  Patients who underwent emergency surgery and neurosurgery&#xD;
&#xD;
          -  Pacients who had an increased QT interval on the electrocardiogram&#xD;
&#xD;
          -  History of allergy to dexametasone, ondansetron or droperidol&#xD;
&#xD;
          -  Refusal to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roger Chammas</last_name>
    <role>Study Director</role>
    <affiliation>Instituto do Cancer do Estado de São Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cancer Institute of the State of Sao Paulo - ICESP</name>
      <address>
        <city>Sao Paulo</city>
        <state>São Paulo</state>
        <zip>01403010</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>May 17, 2021</last_update_submitted>
  <last_update_submitted_qc>May 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>nausea</keyword>
  <keyword>vomiting</keyword>
  <keyword>chemoterapy</keyword>
  <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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Droperidol</mesh_term>
  </intervention_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/NCT04411069
org study id: NP 1336/18
nct id: NCT04411069
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Previous history of nausea and vomiting induced by prior chemotherapy still not included as
      predictive factor of postoperative nausea and vomiting, although has been demonstrated that
      has influence in postoperative outcome.

      The project aims to evaluate the efficacy of a simplified algorithm in prevention
      postoperative nausea and vomiting , with pacients with previous history of nausea and
      vomiting induced by prior chemotherapy, submitted to medium or large surgery.
Quasi-experimental study, with evaluation after the application of a specific postoperative
      nausea and vomiting prevention algorithm for cancer patients.

      The study will be carried out in 2 phases:

      Phase 1: Team training. In this phase, a protocol was established for PONV prophylaxis, using
      two questions:

        1. Patient undergoing chemotherapy before surgery;

        2. Patient presented chemotherapy induced nausea and vomiting (CINV).

      If the answer is yes to both questions, the anesthetist administers 3 antiemetics (4mg
      dexametasone, 4mg ondansetron and 0,625mg droperidol). If the answer is no to one of the
      questions, the anesthetist administers 2 antiemetics (4mg dexametasone and 4mg ondansetron);
      In this phase, educational measures will be implemented by team meetings and individual
      approach of all anesthesiologists at ICESP to present the study project and the algorithm. A
      summary of the the study will be sent daily through the social network Whats App®.

      The number of patients was calculated taking into account adherence to the new prophylaxis
      protocol for post-operative nausea and vomiting. If we consider an alpha error of 5% and test
      power of 80%, to have a NVPO reduction of 41% (current overall incidence) to 25% (incidence
      after protocol adherence) in high-risk patients, we need to study 270 patients (135 each
      group adherence and non-adherence to the protocol).

      Phase 2: Post-training assessment. In the second phase of the study, after the end of the
      dissemination of the protocol among doctors, the patients will be evaluated on the first
      postoperative day. The following variables were analyzed: sex, race, age, body mass index,
      general state of American Society of Anesthesiologist, Apfel scale, type of surgery and
      anesthesia, use and type of opioids, history of chemotherapy induced nausea and vomiting,
      type of antiemetics used in the operating room and in the first postoperative day, duration
      of anesthesia and surgery and nausea and vomiting in 6 and 24 hours after surgery.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
masking description: The patient didn't know if he received the third anti emetic
measure: postoperative nausea and vomiting
time frame: from 0 to 24 postoperative hours
description: record of any episode of nausea and or vomiting in the 24 postoperative hours
measure: Changing in the institutional protocol
time frame: from the begining to the study to the end of the study (2 years)
description: number of patients with chemotherapy-induced nausea and vomiting that received 3 antiemetics in the operating room
arm group label: Patients without previous CINV
arm group type: No Intervention
description: Patients who didn't have chemotherapy or that didn´t have any nausea and/or vomiting induced by chemotherapy (CINV) before surgery
arm group label: Patients with previous CINV
arm group type: Other
description: Patients who had previous nausea and vomiting induced by chemoterapy.
intervention type: Drug
intervention name: Droperidol
description: Pacients who had nausea and vomiting induced by chemotherapy will receive three anti emetic drugs: 4mg dexametasone, 4 mg ondansetron and 0,625 mg droperidol
arm group label: Patients with previous CINV
other name: Intravenous droperidol
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Roger Chammas
role: Study Director
affiliation: Instituto do Cancer do Estado de São Paulo
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Nausea
mesh term: Vomiting
mesh term: Postoperative Nausea and Vomiting
mesh term: Droperidol
sharing ipd: No