<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/NCT03023306</url>
  </required_header>
  <id_info>
    <org_study_id>IRB No 65/19-06-18</org_study_id>
    <nct_id>NCT03023306</nct_id>
  </id_info>
  <brief_title>Preemptive Versus Preventive Antiemetic Treatment</brief_title>
  <official_title>Effectiveness of Preemptive Versus Preventive Antiemetic Treatment in Patients Undergoing Laparoscopic Cholecystectomy. A Randomized Double Blind Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Athens</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Athens</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients aged between 20 and 70 years, ASA physical status I-III, and scheduled for&#xD;
      laparoscopic cholecystectomy under general anaesthesia will be enrolled in the study.&#xD;
&#xD;
      Patients will be randomized to the preemptive group to receive an antiemetic regime 1h before&#xD;
      the start of surgery or to the intraoperative group to receive the same antiemetic drugs in&#xD;
      the same doses intraoperatively, 30 min before the end of surgery.&#xD;
&#xD;
      In the operating room standard monitoring and a standardized anesthetic technique will be&#xD;
      implemented in all patients. Nausea, vomiting, retching and PONV (cumulative) will be&#xD;
      recorded at PACU, at 4h, 8h and 24h postoperatively. Pain scores assessed by NRS (numerical&#xD;
      rating scale) will be recorded at the same time points. Also, when patients received fluids&#xD;
      and solid food by mouth will be recorded.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 2018</start_date>
  <completion_date type="Anticipated">November 2020</completion_date>
  <primary_completion_date type="Anticipated">November 2020</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PONV (postoperative nausea vomiting combined)</measure>
    <time_frame>24 hours</time_frame>
    <description>Incidence of combined nausea and vomiting postoperatively</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>postoperative nausea frequency and intensity</measure>
    <time_frame>24 hours</time_frame>
    <description>numerical rating scale of nausea intensity (0-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative vomiting frequency</measure>
    <time_frame>24 hours</time_frame>
    <description>number of vomits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative pain</measure>
    <time_frame>24 hours</time_frame>
    <description>numerical rating scale of pain intensity (0-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>retching</measure>
    <time_frame>24 hours</time_frame>
    <description>if retching exists</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PONV (postoperative nausea vomiting combined)</measure>
    <time_frame>24 hours</time_frame>
    <description>frequency and intensity of nausea and vomiting</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">115</enrollment>
  <condition>Postoperative Nausea and Vomiting</condition>
  <arm_group>
    <arm_group_label>preemptive group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The preemptive group will receive the anti-emetic regimen i.v. (4 mg of ondansetron) 1h before the start of surgery. During surgery, 30 min before the end of operation, this group will receive i.v. 0.9% NaCl in equal volumes.The intervention consists of the different time points of antiemetic treatment, thus 1h before surgery vs intraopertively.&#xD;
Intervention: Antiemetic treatment 1h before surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>intraoperative group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The preventive group will receive i.v. 0.9% NaCl 1h before surgery and ondansetron 4 mg 30 min before the end of surgery at equal volumes.&#xD;
Intervention: Antiemetic treatment intraoperatively</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Antiemetics perioperatively</intervention_name>
    <description>Preemptive group ondansetron 4 mg will be administered 1h before surgery Intraoperative group Ondansetron 4 mg will be administered intraoperatively</description>
    <arm_group_label>intraoperative group</arm_group_label>
    <arm_group_label>preemptive group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA physical status I-III patients&#xD;
&#xD;
          -  Surgical procedure: scheduled for laparoscopic cholecystectomy&#xD;
&#xD;
          -  Type of anesthesia: general&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Antihistamines the last three days&#xD;
&#xD;
          -  Antiemetic drugs the last three days&#xD;
&#xD;
          -  Hiatus hernia&#xD;
&#xD;
          -  reflux&#xD;
&#xD;
          -  Gastrointestinal disease&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  BMI &gt; 35&#xD;
&#xD;
          -  parkinson&#xD;
&#xD;
          -  known allergy to the drugs of the protocol&#xD;
&#xD;
          -  epilepsy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Argyro Fassoulaki, MD PhD DEAA</last_name>
    <phone>306936701333</phone>
    <email>afassou1@otenet.gr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Chryssoula Staikou, MD, PhD, DESA</last_name>
    <phone>00306932352742</phone>
    <email>c_staikou@yahoo.gr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Aretaieio University Hospital</name>
      <address>
        <city>Athens</city>
        <state>Attika</state>
        <zip>11528</zip>
        <country>Greece</country>
      </address>
    </facility>
    <contact>
      <last_name>Argyro Fassoulaki, MD PhD DEAA</last_name>
      <phone>306936701333</phone>
      <email>fassoula@aretaieio.uoa.gr</email>
    </contact>
    <contact_backup>
      <last_name>Chryssoula Staikou, MD PhD DESA</last_name>
      <phone>00306932352742</phone>
      <email>c_staikou@yahoo.gr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <reference>
    <citation>Odom-Forren J, Rayens MK, Gokun Y, Jalota L, Radke O, Hooper V, Wiggins AT, Apfel CC. The Relationship of Pain and Nausea in Postoperative Patients for 1 Week After Ambulatory Surgery. Clin J Pain. 2015 Oct;31(10):845-51. doi: 10.1097/AJP.0000000000000170.</citation>
    <PMID>25370136</PMID>
  </reference>
  <reference>
    <citation>Gan TJ, Diemunsch P, Habib AS, Kovac A, Kranke P, Meyer TA, Watcha M, Chung F, Angus S, Apfel CC, Bergese SD, Candiotti KA, Chan MT, Davis PJ, Hooper VD, Lagoo-Deenadayalan S, Myles P, Nezat G, Philip BK, Tramer MR; Society for Ambulatory Anesthesia. Consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2014 Jan;118(1):85-113. doi: 10.1213/ANE.0000000000000002. Erratum In: Anesth Analg. 2014 Mar;118(3):689. Anesth Analg. 2015 Feb;120(2):494.</citation>
    <PMID>24356162</PMID>
  </reference>
  <reference>
    <citation>Apfel CC, Heidrich FM, Jukar-Rao S, Jalota L, Hornuss C, Whelan RP, Zhang K, Cakmakkaya OS. Evidence-based analysis of risk factors for postoperative nausea and vomiting. Br J Anaesth. 2012 Nov;109(5):742-53. doi: 10.1093/bja/aes276. Epub 2012 Oct 3.</citation>
    <PMID>23035051</PMID>
  </reference>
  <reference>
    <citation>Apfel CC, Meyer A, Orhan-Sungur M, Jalota L, Whelan RP, Jukar-Rao S. Supplemental intravenous crystalloids for the prevention of postoperative nausea and vomiting: quantitative review. Br J Anaesth. 2012 Jun;108(6):893-902. doi: 10.1093/bja/aes138.</citation>
    <PMID>22593126</PMID>
  </reference>
  <reference>
    <citation>Wallden J, Flodin J, Hultin M. Validation of a prediction model for post-discharge nausea and vomiting after general anaesthesia in a cohort of Swedish ambulatory surgery patients. Eur J Anaesthesiol. 2016 Oct;33(10):743-9. doi: 10.1097/EJA.0000000000000473.</citation>
    <PMID>27270883</PMID>
  </reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>October 31, 2018</last_update_submitted>
  <last_update_submitted_qc>October 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Athens</investigator_affiliation>
    <investigator_full_name>Argyro Fassoulaki</investigator_full_name>
    <investigator_title>Professor Emeritus</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>Antiemetics</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/NCT03023306
org study id: IRB No 65/19-06-18
nct id: NCT03023306
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Patients aged between 20 and 70 years, ASA physical status I-III, and scheduled for
      laparoscopic cholecystectomy under general anaesthesia will be enrolled in the study.

      Patients will be randomized to the preemptive group to receive an antiemetic regime 1h before
      the start of surgery or to the intraoperative group to receive the same antiemetic drugs in
      the same doses intraoperatively, 30 min before the end of surgery.

      In the operating room standard monitoring and a standardized anesthetic technique will be
      implemented in all patients. Nausea, vomiting, retching and PONV (cumulative) will be
      recorded at PACU, at 4h, 8h and 24h postoperatively. Pain scores assessed by NRS (numerical
      rating scale) will be recorded at the same time points. Also, when patients received fluids
      and solid food by mouth will be recorded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: PONV (postoperative nausea vomiting combined)
time frame: 24 hours
description: Incidence of combined nausea and vomiting postoperatively
measure: postoperative nausea frequency and intensity
time frame: 24 hours
description: numerical rating scale of nausea intensity (0-10)
measure: postoperative vomiting frequency
time frame: 24 hours
description: number of vomits
measure: postoperative pain
time frame: 24 hours
description: numerical rating scale of pain intensity (0-10)
measure: retching
time frame: 24 hours
description: if retching exists
measure: PONV (postoperative nausea vomiting combined)
time frame: 24 hours
description: frequency and intensity of nausea and vomiting
arm group label: preemptive group
arm group type: Active Comparator
description: The preemptive group will receive the anti-emetic regimen i.v. (4 mg of ondansetron) 1h before the start of surgery. During surgery, 30 min before the end of operation, this group will receive i.v. 0.9% NaCl in equal volumes.The intervention consists of the different time points of antiemetic treatment, thus 1h before surgery vs intraopertively.
Intervention: Antiemetic treatment 1h before surgery
arm group label: intraoperative group
arm group type: Other
description: The preventive group will receive i.v. 0.9% NaCl 1h before surgery and ondansetron 4 mg 30 min before the end of surgery at equal volumes.
Intervention: Antiemetic treatment intraoperatively
intervention type: Other
intervention name: Antiemetics perioperatively
description: Preemptive group ondansetron 4 mg will be administered 1h before surgery Intraoperative group Ondansetron 4 mg will be administered intraoperatively
arm group label: intraoperative group
arm group label: preemptive group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Argyro Fassoulaki, MD PhD DEAA
phone: 306936701333
email: afassou1@otenet.gr
last name: Chryssoula Staikou, MD, PhD, DESA
phone: 00306932352742
email: c_staikou@yahoo.gr
facility: 
contact: 
contact backup: 
country: Greece
citation: Odom-Forren J, Rayens MK, Gokun Y, Jalota L, Radke O, Hooper V, Wiggins AT, Apfel CC. The Relationship of Pain and Nausea in Postoperative Patients for 1 Week After Ambulatory Surgery. Clin J Pain. 2015 Oct;31(10):845-51. doi: 10.1097/AJP.0000000000000170.
PMID: 25370136
citation: Gan TJ, Diemunsch P, Habib AS, Kovac A, Kranke P, Meyer TA, Watcha M, Chung F, Angus S, Apfel CC, Bergese SD, Candiotti KA, Chan MT, Davis PJ, Hooper VD, Lagoo-Deenadayalan S, Myles P, Nezat G, Philip BK, Tramer MR; Society for Ambulatory Anesthesia. Consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2014 Jan;118(1):85-113. doi: 10.1213/ANE.0000000000000002. Erratum In: Anesth Analg. 2014 Mar;118(3):689. Anesth Analg. 2015 Feb;120(2):494.
PMID: 24356162
citation: Apfel CC, Heidrich FM, Jukar-Rao S, Jalota L, Hornuss C, Whelan RP, Zhang K, Cakmakkaya OS. Evidence-based analysis of risk factors for postoperative nausea and vomiting. Br J Anaesth. 2012 Nov;109(5):742-53. doi: 10.1093/bja/aes276. Epub 2012 Oct 3.
PMID: 23035051
citation: Apfel CC, Meyer A, Orhan-Sungur M, Jalota L, Whelan RP, Jukar-Rao S. Supplemental intravenous crystalloids for the prevention of postoperative nausea and vomiting: quantitative review. Br J Anaesth. 2012 Jun;108(6):893-902. doi: 10.1093/bja/aes138.
PMID: 22593126
citation: Wallden J, Flodin J, Hultin M. Validation of a prediction model for post-discharge nausea and vomiting after general anaesthesia in a cohort of Swedish ambulatory surgery patients. Eur J Anaesthesiol. 2016 Oct;33(10):743-9. doi: 10.1097/EJA.0000000000000473.
PMID: 27270883
responsible party type: Principal Investigator
investigator affiliation: University of Athens
investigator full name: Argyro Fassoulaki
investigator title: Professor Emeritus
mesh term: Vomiting
mesh term: Postoperative Nausea and Vomiting
mesh term: Antiemetics
sharing ipd: No