<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/NCT04403191</url>
  </required_header>
  <id_info>
    <org_study_id>ICU-10-20</org_study_id>
    <nct_id>NCT04403191</nct_id>
  </id_info>
  <brief_title>Usage of Multiple Drugs in Treatment of Postoperative Vomiting After Laparoscopic Appendectomy</brief_title>
  <official_title>Comparative Study Between Ondansetron, Isopropyl Alcohol Inhalation and Super Hydration in Treatment of Postoperative Emesis After Laparoscopic Appendectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Abdul Aziz Specialist Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Abdul Aziz Specialist Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare and evaluate the antiemetic effect and the safety of ondansetron, inhalational&#xD;
      isopropyl alcohol and super hydration on adult patients after laparoscopic appendectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective double-blind study done on 240 patients admitted to surgical I.C.U after&#xD;
      laparoscopic appendectomy. Those who had preoperative Koivuranta vomiting score of more than&#xD;
      3 enrolled in our study. Every group contains 80 patients. Patients of group A received&#xD;
      ondansetron 4 mg intravenous immediately once reached to I.C.U and another same dose after 6&#xD;
      hours while patients of group B received isopropyl alcohol 70% inhalation every 15 min for 4&#xD;
      times then repeated after 6 hours. The last group C received intravenous normal saline at&#xD;
      rate of 20 ml/kg over 30 minute and repeated by the same dose after 6 hours. The duration of&#xD;
      the study was 24 hours post-operatively. As PONV is self-limited within 24 hours.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 10, 2019</start_date>
  <completion_date type="Actual">February 10, 2020</completion_date>
  <primary_completion_date type="Actual">February 4, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>numbers of vomiting attacks</measure>
    <time_frame>for one day</time_frame>
    <description>numbers of vomiting attacks recorded every 15 minutes for one day</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">240</enrollment>
  <condition>to Treat the Vomiting Frequently Occur Post-laparoscopic by Different Anti Emetic Drugs</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <description>received ondansetron 4 mg intravenous immediately once reached to I.C.U and another same dose after 6 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <description>received isopropyl alcohol 70% inhalation every 15 min for 4 times then repeated after 6 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <description>received intravenous normal saline at rate of 20 ml/kg over 30 minute and repeated by the same dose after 6 hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ondansetron</intervention_name>
    <description>ondansetron 4 mg intravenous immediately once reached to I.C.U and another same dose after 6 hours while patients of group</description>
    <arm_group_label>Group A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>isopropyl alcohol 70% inhalation</intervention_name>
    <description>inhalation every 15 min for 4 times then repeated after 6 hours</description>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>laparoscopic appendectomy</intervention_name>
    <description>all patients received post operatively after laparoscopic appenectomy</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_label>Group C</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        240 patients admitted to surgical I.C.U of King Abdul-Aziz specialist hospital for&#xD;
        post-operative care after laparoscopic appendectomy surgery between March 2019 till&#xD;
        February 2020. A Koivuranta Score to Predict Postoperative Nausea and Vomiting done&#xD;
        preoperatively for all the patients and only those who had score of more than 3 on&#xD;
        Koivuranta vomiting score (had more than 60% chance to develop PONV) enrolled in our study.&#xD;
        And randomly allocated in one of three groups group A, B or C.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        postoperative nausea and vomiting&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        systemic disease as diabetes or hypertension local gastric diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>King abd el Aziz specialist hospital</name>
      <address>
        <city>Taif</city>
        <zip>21944</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vomiting</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ondansetron</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>To compare and evaluate the antiemetic effect and the safety of ondansetron, inhalational isopropyl alcohol and super hydration on adult patients after laparoscopic appendectomy.</ipd_description>
  </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/NCT04403191
org study id: ICU-10-20
nct id: NCT04403191
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
To compare and evaluate the antiemetic effect and the safety of ondansetron, inhalational
      isopropyl alcohol and super hydration on adult patients after laparoscopic appendectomy.
This prospective double-blind study done on 240 patients admitted to surgical I.C.U after
      laparoscopic appendectomy. Those who had preoperative Koivuranta vomiting score of more than
      3 enrolled in our study. Every group contains 80 patients. Patients of group A received
      ondansetron 4 mg intravenous immediately once reached to I.C.U and another same dose after 6
      hours while patients of group B received isopropyl alcohol 70% inhalation every 15 min for 4
      times then repeated after 6 hours. The last group C received intravenous normal saline at
      rate of 20 ml/kg over 30 minute and repeated by the same dose after 6 hours. The duration of
      the study was 24 hours post-operatively. As PONV is self-limited within 24 hours.
observational model: Cohort
time perspective: Prospective
measure: numbers of vomiting attacks
time frame: for one day
description: numbers of vomiting attacks recorded every 15 minutes for one day
arm group label: Group A
description: received ondansetron 4 mg intravenous immediately once reached to I.C.U and another same dose after 6 hours
arm group label: Group B
description: received isopropyl alcohol 70% inhalation every 15 min for 4 times then repeated after 6 hours
arm group label: Group C
description: received intravenous normal saline at rate of 20 ml/kg over 30 minute and repeated by the same dose after 6 hours.
intervention type: Drug
intervention name: Ondansetron
description: ondansetron 4 mg intravenous immediately once reached to I.C.U and another same dose after 6 hours while patients of group
arm group label: Group A
intervention type: Drug
intervention name: isopropyl alcohol 70% inhalation
description: inhalation every 15 min for 4 times then repeated after 6 hours
arm group label: Group B
intervention type: Procedure
intervention name: laparoscopic appendectomy
description: all patients received post operatively after laparoscopic appenectomy
arm group label: Group A
arm group label: Group B
arm group label: Group C
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Saudi Arabia
responsible party type: Sponsor
mesh term: Vomiting
mesh term: Ondansetron
sharing ipd: No
ipd description: To compare and evaluate the antiemetic effect and the safety of ondansetron, inhalational isopropyl alcohol and super hydration on adult patients after laparoscopic appendectomy.