<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/NCT03834259</url>
  </required_header>
  <id_info>
    <org_study_id>GK12</org_study_id>
    <nct_id>NCT03834259</nct_id>
  </id_info>
  <brief_title>The Effects of Keeping the Patient in a Sitting Position for One Minute After Spinal Anesthesia</brief_title>
  <official_title>The Effects of Keeping the Patient in a Sitting Position for One Minute After Spinal Anesthesia on Hypotension, Nausea-vomiting and Ephedrine Consumption</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Umraniye Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Umraniye Education and Research 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>
      The aim of this study was to examine the effect of keeping the patient in a sitting position&#xD;
      for 1 minute after spinal anaesthesia in elective caesarean operations, primarily on the&#xD;
      formation of hypotension and secondarily on nausea-vomiting, the need for ephedrine and the&#xD;
      block characteristics.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">December 1, 2017</completion_date>
  <primary_completion_date type="Actual">November 1, 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>systolic arterial hypotension</measure>
    <time_frame>every 3 minutes until the delivery and every 5 minutes until the end of surgery</time_frame>
    <description>reduction of &gt;25% in the basal systolic arterial pressure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>sensory block</measure>
    <time_frame>10 minutes after spinal block</time_frame>
    <description>assesment of the time to reach T12 level with pin prick test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ephedrine requirement time</measure>
    <time_frame>1 hour after spinal block</time_frame>
    <description>the time to first administration of ephedrine as minutes after spinal block</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>amount of ephedrine</measure>
    <time_frame>1 hour after spinal block</time_frame>
    <description>administrated total ephedrine dosage as mg during surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>surgeon and patient satisfaction</measure>
    <time_frame>24 hours after spinal block</time_frame>
    <description>1= poor, 2=fair, 3= good, 4= very good</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>motor block</measure>
    <time_frame>24 hours after spinal block</time_frame>
    <description>time to Bromage Score 0 after applying spinal block</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">214</enrollment>
  <condition>Hypotension</condition>
  <condition>Spinal Anaesthesia</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>12.5 mg 0.5% hyperbaric bupivacaine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>10 mg 0.5% hyperbaric bupivacaine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>12.5 mg 0.5% hyperbaric bupivacaine</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>sitting position</intervention_name>
    <description>keeping the patient in a sitting position after spinal anaesthesia</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>supine position</intervention_name>
    <description>keeping the patient in supine position after spinal anaesthesia</description>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged 18 - 45 years,&#xD;
&#xD;
          -  ASA physical status&#xD;
&#xD;
          -  I - II,&#xD;
&#xD;
          -  BMI of 25-30&#xD;
&#xD;
          -  who were undergoing elective CS&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  vertebral anomaly,&#xD;
&#xD;
          -  peripheral vascular disease,&#xD;
&#xD;
          -  cardiovascular or psychiatric disorder,&#xD;
&#xD;
          -  severe anemia,&#xD;
&#xD;
          -  coagulopathy&#xD;
&#xD;
          -  infection in the intervention region&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>the study was designed in caesarean section operations</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>February 6, 2019</last_update_submitted>
  <last_update_submitted_qc>February 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Umraniye Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Gulsah Karaoren</investigator_full_name>
    <investigator_title>associate professor</investigator_title>
  </responsible_party>
  <keyword>spinal anaesthesia</keyword>
  <keyword>ephedrine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypotension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03834259
org study id: GK12
nct id: NCT03834259
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to examine the effect of keeping the patient in a sitting position
      for 1 minute after spinal anaesthesia in elective caesarean operations, primarily on the
      formation of hypotension and secondarily on nausea-vomiting, the need for ephedrine and the
      block characteristics.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: systolic arterial hypotension
time frame: every 3 minutes until the delivery and every 5 minutes until the end of surgery
description: reduction of >25% in the basal systolic arterial pressure
measure: sensory block
time frame: 10 minutes after spinal block
description: assesment of the time to reach T12 level with pin prick test
measure: ephedrine requirement time
time frame: 1 hour after spinal block
description: the time to first administration of ephedrine as minutes after spinal block
measure: amount of ephedrine
time frame: 1 hour after spinal block
description: administrated total ephedrine dosage as mg during surgery
measure: surgeon and patient satisfaction
time frame: 24 hours after spinal block
description: 1= poor, 2=fair, 3= good, 4= very good
measure: motor block
time frame: 24 hours after spinal block
description: time to Bromage Score 0 after applying spinal block
arm group label: Group 1
arm group type: Active Comparator
description: 12.5 mg 0.5% hyperbaric bupivacaine
arm group label: Group 2
arm group type: Active Comparator
description: 10 mg 0.5% hyperbaric bupivacaine
arm group label: Group 3
arm group type: Active Comparator
description: 12.5 mg 0.5% hyperbaric bupivacaine
intervention type: Procedure
intervention name: sitting position
description: keeping the patient in a sitting position after spinal anaesthesia
arm group label: Group 1
intervention type: Procedure
intervention name: supine position
description: keeping the patient in supine position after spinal anaesthesia
arm group label: Group 2
arm group label: Group 3
criteria: 
gender: Female
gender based: Yes
gender description: the study was designed in caesarean section operations
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Umraniye Education and Research Hospital
investigator full name: Gulsah Karaoren
investigator title: associate professor
mesh term: Hypotension
sharing ipd: Undecided