<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/NCT03789370</url>
  </required_header>
  <id_info>
    <org_study_id>06-11-14</org_study_id>
    <nct_id>NCT03789370</nct_id>
  </id_info>
  <brief_title>Maintenance of Anaesthesia With Sevoflurane Versus Propofol and the Occurrence of Postoperative Headache.</brief_title>
  <official_title>Maintenance of Anaesthesia With Sevoflurane Versus Propofol and the Occurrence of Postoperative Headache.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Attikon Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Attikon Hospital</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>
      Postoperative headache is a major issue after general anaesthesia and surgery. The aim of&#xD;
      this study is to investigate the possible difference in the occurrence of postoperative&#xD;
      headache when general anaesthesia is maintained with propofol, which is supposed to have&#xD;
      protective effects on migraine patients, versus sevoflurane.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperative headache is a major issue after general anaesthesia and surgery. The aim of&#xD;
      this study is to investigate the possible difference in the occurrence of postoperative&#xD;
      headache when general anaesthesia is maintained with propofol, versus sevoflurane. Propofol&#xD;
      acts throught a GABA, and is known to have a therapeutic effect on migraine patients with&#xD;
      accute attacts. However, its role on postoperative headache has not been studied, when used&#xD;
      for maintainance of anaesthesia, this study aims to investigate the occurrence of headache&#xD;
      after anaesthesia and surgery, when patients receive randomly two different anaesthetics:&#xD;
      propofol and sevoflurane.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 7, 2014</start_date>
  <completion_date type="Anticipated">October 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 30, 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>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The patient and the outcomes assessor will not know what kind of anaesthetic drug was used for maintainance of anaesthesia.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of postoperative headache (yes or no)</measure>
    <time_frame>up to 24 hours postoperatively</time_frame>
    <description>Rate of postoperative headache in patients receiving sevoflurane versus propofol (yes or no headache)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Nausea and vomiting</measure>
    <time_frame>up to 24 hours postoperatively</time_frame>
    <description>Which anaesthetic (propofol or sevoflurane) is associated with less postoperative nausea and vomiting</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">130</enrollment>
  <condition>Headache</condition>
  <arm_group>
    <arm_group_label>Propofol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Total intravenous anaesthesia with propofol for maintainance of anaesthesia.Dose adjusted according to the Bispectral Index (BIS) indication (maintained 40-50). Initial dose 10 mg/kg/h for10 min, 8 mg/kg/h for 10 min and then 6 mg/kg/h).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sevoflurane</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sevoflurane for maintainance of anaesthesia. Dose 1 MAC adjusted according to the Bispectral Index (BIS) indication (maintained 40-50).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>Maintanance of general anaesthesia with propofol</description>
    <arm_group_label>Propofol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sevoflurane</intervention_name>
    <description>Maintainance of general anaesthesia with sevoflurane.</description>
    <arm_group_label>Sevoflurane</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I-III&#xD;
&#xD;
          -  scheduled operation under general anaesthesia&#xD;
&#xD;
          -  operations &lt;4 hours&#xD;
&#xD;
          -  minorgynaecological operatios (leiomyomectomy)&#xD;
&#xD;
          -  hernia repair&#xD;
&#xD;
          -  arthroscopic procedurs&#xD;
&#xD;
          -  minor orthopaedic operations without the use of tourniquet or cement&#xD;
&#xD;
          -  saphenectomy&#xD;
&#xD;
          -  minor urologic operations&#xD;
&#xD;
          -  minor other operations of general surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt;18 and &gt;65 years old&#xD;
&#xD;
          -  ASA&gt;III&#xD;
&#xD;
          -  Diseases of the central nervous system (ie Parkinsons's disease, Multiple sclerosis,&#xD;
             previous ischaemic attack, hydrocephalus, seizure disorder, etc)&#xD;
&#xD;
          -  Psychosis under medication&#xD;
&#xD;
          -  Cognitive impairement or/and inability to fill in the questionaires&#xD;
&#xD;
          -  Allergy or contraindication to the study protocol included drugs&#xD;
&#xD;
          -  Operations of more than 4 hours duration&#xD;
&#xD;
          -  Head and neck procedures, procedures with neck extension (eg thyroidectomy), ENT&#xD;
             procedures&#xD;
&#xD;
          -  renal impairement&#xD;
&#xD;
          -  hepatic impairement&#xD;
&#xD;
          -  patient refusal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Chrysanthi Batistaki, MD, PhD</last_name>
    <phone>00302105832371</phone>
    <email>chrysabatistaki@yahoo.gr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Georgia Kostopanagiotou, MD, PhD</last_name>
    <phone>00302105832371</phone>
    <email>banesthclin@attikonhospital.gr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.</name>
      <address>
        <city>Athens</city>
        <zip>12462</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chrysanthi Batistaki, MD, PhD</last_name>
      <phone>0030 210 5832371</phone>
      <email>chrysabatistaki@yahoo.gr</email>
    </contact>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>January 15, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>November 16, 2019</last_update_submitted>
  <last_update_submitted_qc>November 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Attikon Hospital</investigator_affiliation>
    <investigator_full_name>Chrysanthi Batistaki</investigator_full_name>
    <investigator_title>Assistant Professor of Anaesthesiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Headache</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propofol</mesh_term>
    <mesh_term>Sevoflurane</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03789370
org study id: 06-11-14
nct id: NCT03789370
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Postoperative headache is a major issue after general anaesthesia and surgery. The aim of
      this study is to investigate the possible difference in the occurrence of postoperative
      headache when general anaesthesia is maintained with propofol, which is supposed to have
      protective effects on migraine patients, versus sevoflurane.
Postoperative headache is a major issue after general anaesthesia and surgery. The aim of
      this study is to investigate the possible difference in the occurrence of postoperative
      headache when general anaesthesia is maintained with propofol, versus sevoflurane. Propofol
      acts throught a GABA, and is known to have a therapeutic effect on migraine patients with
      accute attacts. However, its role on postoperative headache has not been studied, when used
      for maintainance of anaesthesia, this study aims to investigate the occurrence of headache
      after anaesthesia and surgery, when patients receive randomly two different anaesthetics:
      propofol and sevoflurane.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
masking description: The patient and the outcomes assessor will not know what kind of anaesthetic drug was used for maintainance of anaesthesia.
measure: incidence of postoperative headache (yes or no)
time frame: up to 24 hours postoperatively
description: Rate of postoperative headache in patients receiving sevoflurane versus propofol (yes or no headache)
measure: Nausea and vomiting
time frame: up to 24 hours postoperatively
description: Which anaesthetic (propofol or sevoflurane) is associated with less postoperative nausea and vomiting
arm group label: Propofol
arm group type: Active Comparator
description: Total intravenous anaesthesia with propofol for maintainance of anaesthesia.Dose adjusted according to the Bispectral Index (BIS) indication (maintained 40-50). Initial dose 10 mg/kg/h for10 min, 8 mg/kg/h for 10 min and then 6 mg/kg/h).
arm group label: Sevoflurane
arm group type: Active Comparator
description: Sevoflurane for maintainance of anaesthesia. Dose 1 MAC adjusted according to the Bispectral Index (BIS) indication (maintained 40-50).
intervention type: Drug
intervention name: Propofol
description: Maintanance of general anaesthesia with propofol
arm group label: Propofol
intervention type: Drug
intervention name: Sevoflurane
description: Maintainance of general anaesthesia with sevoflurane.
arm group label: Sevoflurane
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Chrysanthi Batistaki, MD, PhD
phone: 00302105832371
email: chrysabatistaki@yahoo.gr
last name: Georgia Kostopanagiotou, MD, PhD
phone: 00302105832371
email: banesthclin@attikonhospital.gr
facility: 
status: Recruiting
contact: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: Attikon Hospital
investigator full name: Chrysanthi Batistaki
investigator title: Assistant Professor of Anaesthesiology
mesh term: Headache
mesh term: Propofol
mesh term: Sevoflurane