<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/NCT03810547</url>
  </required_header>
  <id_info>
    <org_study_id>ASUH1011/17</org_study_id>
    <nct_id>NCT03810547</nct_id>
  </id_info>
  <brief_title>Abdominoplasty Under Spinal Anesthesia</brief_title>
  <official_title>A Comparative Study Between Spinal and General Anesthesia for Abdominoplasty.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</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>
      100 patients undergoing abdominoplasty under spinal anesthesia. 100 patients undergoing&#xD;
      abdominoplasty under general anesthesia&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      200 patients, American Society of Anesthesiologists (ASA) physical status classes I and II,&#xD;
      were enrolled in this feasible study. All patients were subjected to abdominoplasty operation&#xD;
      under spinal anesthesia or general anesthesia. Any intraoperative complications like&#xD;
      hypotension, bradycardia, pain, nausea and vomiting related to spinal anesthesia were managed&#xD;
      and recorded. Postoperative visual analogue scale (VAS) was used to assess pain severity and&#xD;
      the need for analgesia to be administered.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 30, 2017</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">April 30, 2018</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>Supportive Care</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Pain sensation: Visual analogue scale</measure>
    <time_frame>pain assessment during the operation and every 4 hours for 12 hours</time_frame>
    <description>Visual analogue scale for Pain assessment from 1 with least pain to 10 with maximum pain felt</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patients satisfaction: Satisfaction score changes</measure>
    <time_frame>Intraoperative assessment every 30 minutes till end of surgery.</time_frame>
    <description>Satisfaction score with maximum score is fully satisfied and least is completely disagree</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Spinal Anesthesia Suitability for Abdominoplasty</condition>
  <arm_group>
    <arm_group_label>Spinal anesthesia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients undergoing abdominoplasty under spinal anesthesia may need to drug administration like propofol or ketamine or change anesthesia to general anesthesia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>General anesthesia</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>General anesthesia for abdominoplasty</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol 10 Mg/mL Intravenous Emulsion</intervention_name>
    <description>when spinal anesthesia is not satisfactory intervention drugs are used</description>
    <arm_group_label>Spinal anesthesia</arm_group_label>
    <other_name>ketamine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients between 18-55 years&#xD;
&#xD;
          -  ASA I and II&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI more than 35 years&#xD;
&#xD;
          -  Contraindications for regional anesthesia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ain Shams University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>January 17, 2019</last_update_submitted>
  <last_update_submitted_qc>January 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Ayman Anis Metry</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>Abdominoplasty</keyword>
  <keyword>spinal anesthesia</keyword>
  <keyword>general anesthesia</keyword>
  <keyword>postoperative pain</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketamine</mesh_term>
    <mesh_term>Propofol</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/NCT03810547
org study id: ASUH1011/17
nct id: NCT03810547
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
100 patients undergoing abdominoplasty under spinal anesthesia. 100 patients undergoing
      abdominoplasty under general anesthesia
200 patients, American Society of Anesthesiologists (ASA) physical status classes I and II,
      were enrolled in this feasible study. All patients were subjected to abdominoplasty operation
      under spinal anesthesia or general anesthesia. Any intraoperative complications like
      hypotension, bradycardia, pain, nausea and vomiting related to spinal anesthesia were managed
      and recorded. Postoperative visual analogue scale (VAS) was used to assess pain severity and
      the need for analgesia to be administered.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Care Provider)
measure: Change in Pain sensation: Visual analogue scale
time frame: pain assessment during the operation and every 4 hours for 12 hours
description: Visual analogue scale for Pain assessment from 1 with least pain to 10 with maximum pain felt
measure: Patients satisfaction: Satisfaction score changes
time frame: Intraoperative assessment every 30 minutes till end of surgery.
description: Satisfaction score with maximum score is fully satisfied and least is completely disagree
arm group label: Spinal anesthesia
arm group type: Active Comparator
description: Patients undergoing abdominoplasty under spinal anesthesia may need to drug administration like propofol or ketamine or change anesthesia to general anesthesia.
arm group label: General anesthesia
arm group type: No Intervention
description: General anesthesia for abdominoplasty
intervention type: Drug
intervention name: Propofol 10 Mg/mL Intravenous Emulsion
description: when spinal anesthesia is not satisfactory intervention drugs are used
arm group label: Spinal anesthesia
other name: ketamine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Ayman Anis Metry
investigator title: Assistant professor
mesh term: Ketamine
mesh term: Propofol
sharing ipd: No