xml: <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/NCT06018805</url>
    </required_header>
    <id_info>
      <org_study_id>B.30.2.ATA.0.01.00/408</org_study_id>
      <nct_id>NCT06018805</nct_id>
    </id_info>
    <brief_title>The Effect of Combined Spinal Epidural Anaesthesia on QTc Interval Undergoing Cesarean Section</brief_title>
    <official_title>The Effect of Combined Spinal Epidural Anaesthesia on QTc Interval in Obese and Non-obese Parturients Undergoing Cesarean Section: A Comparative Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ataturk University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ataturk 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>
        Cesarean section is the operation to deliver the fetus, placenta and membranes by making an&#xD;
        abdominal incision in the uterus. Cesarean section is performed for reasons such as&#xD;
        head-pelvis incompatibility, fetal malposition, fetal distress, and previous cesarean&#xD;
        section.&#xD;
  &#xD;
        The most important side effects of spinal anaesthesia are problems such as hypotension,&#xD;
        bradycardia, low back pain, headache, nausea, vomiting, meningitis, meningismus, and urinary&#xD;
        retention.&#xD;
  &#xD;
        Combined spinal-epidural (BSI) anaesthesia is the application of spinal and epidural&#xD;
        anaesthesia together. High-dose local anaesthetics can cause significant hypotension when the&#xD;
        epidural block is administered alone. The administration of spinal anaesthesia alone causes&#xD;
        changes in arterial resistance, stroke volume, heart rate, cardiac output and arterial blood&#xD;
        pressure. Sympathetic blockade leads to arterial vasodilation, and arterial resistance may&#xD;
        decrease by 5-20% during spinal anaesthesia.&#xD;
  &#xD;
        Due to the increased risk of maternal complications in obese pregnant, fetal morbidity and&#xD;
        mortality have increased. In addition, supine hypotension syndrome is a common problem in&#xD;
        obese pregnant women. The aim of this study is to compare the change in QTc interval in obese&#xD;
        and non-obese term pregnancies planned for elective cesarean section with combined spinal&#xD;
        epidural anaesthesia. Thus, it is aimed to develop new protocols that will minimize cardiac&#xD;
        pathologies during and after surgery in obese pregnant women.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 24, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2023</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>Treatment</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>QTc interval</measure>
      <time_frame>first 2 hour starting from the time of CSE performed.</time_frame>
      <description>The primary aim of this study was to reveal the difference in QTc interval between groups.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Analgesia</condition>
    <arm_group>
      <arm_group_label>Body Mass Index≥30 kg/m2</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Pregnant women with a Body Mass Index≥30 kg/m2 will be included.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Body Mass Index: 18,5 - 24,9 kg/m2</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Pregnant women with a Body Mass Index between 18.5 and 24.9 kg/m2 will be included.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>BMI≥30; Combined Spinal Epidural Anesthesia</intervention_name>
      <description>Combined epidural spinal anesthesia will be performed with the loss of resistance method at constant volume and concentration ( in both patient groups. For QT interval measurements, ECG recordings will be taken before spinal anesthesia, 5 and 30 minutes after the block, and 60 and 120 minutes postoperatively.</description>
      <arm_group_label>Body Mass Index≥30 kg/m2</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>BMI:18,5-24,9; Combined Spinal Epidural Anesthesia</intervention_name>
      <description>Combined epidural spinal anesthesia will be performed with the loss of resistance method at constant volume and concentration in both patient groups. For QT interval measurements, ECG recordings will be taken before spinal anesthesia, 5 and 30 minutes after the block, and 60 and 120 minutes postoperatively.</description>
      <arm_group_label>Body Mass Index: 18,5 - 24,9 kg/m2</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants with BMI≥30 and BMI values between 18.5 and 24.9.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  allergic to the drugs used in the study,&#xD;
  &#xD;
            -  who do not accept regional anesthesia,&#xD;
  &#xD;
            -  body mass index did not meet the inclusion criteria in the study,&#xD;
  &#xD;
            -  under 150 cm in height,&#xD;
  &#xD;
            -  who received treatment other than perinatal iron and vitamin drugs,&#xD;
  &#xD;
            -  smoking or drinking alcohol,&#xD;
  &#xD;
            -  with a known fetal anomaly,&#xD;
  &#xD;
            -  with placental disorders such as placenta previa,&#xD;
  &#xD;
            -  with multiple pregnancy&#xD;
  &#xD;
            -  have renal or liver disease,&#xD;
  &#xD;
            -  diagnosed with hypertension or preeclampsia,&#xD;
  &#xD;
            -  uncooperative and previously treated or currently receiving treatment for a&#xD;
               psychiatric disorder&#xD;
  &#xD;
            -  Mothers who do not want to participate in the study will not be included in the study.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mehmet Aksoy</last_name>
      <role>Study Director</role>
      <affiliation>Ataturk University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mehmet Aksoy</last_name>
      <phone>+905058193526</phone>
      <email>drmaksoy@hotmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ataturk University</name>
        <address>
          <city>Erzurum</city>
          <zip>25100</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mehmet Aksoy</last_name>
        <phone>+905058193526</phone>
        <email>drmaksoy@hotmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Kumar T, Jha K, Sharan A, Sakshi P, Kumar S, Kumari A. Study of the effect of obesity on QT-interval among adults. J Family Med Prim Care. 2019 May;8(5):1626-1629. doi: 10.4103/jfmpc.jfmpc_168_19.</citation>
      <PMID>31198727</PMID>
    </reference>
    <reference>
      <citation>Song JH, Yang C, Lee W, Kim H, Kim Y, Kim H. QTc interval prolongation due to spinal anesthesia in patients with and without diabetes: an observational study. BMC Anesthesiol. 2022 May 13;22(1):143. doi: 10.1186/s12871-022-01614-8.</citation>
      <PMID>35562669</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ataturk University</investigator_affiliation>
      <investigator_full_name>Mehmet AKSOY</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anesthetics</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06018805
  org study id: B.30.2.ATA.0.01.00/408
  nct id: NCT06018805
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Cesarean section is the operation to deliver the fetus, placenta and membranes by making an
        abdominal incision in the uterus. Cesarean section is performed for reasons such as
        head-pelvis incompatibility, fetal malposition, fetal distress, and previous cesarean
        section.
  
        The most important side effects of spinal anaesthesia are problems such as hypotension,
        bradycardia, low back pain, headache, nausea, vomiting, meningitis, meningismus, and urinary
        retention.
  
        Combined spinal-epidural (BSI) anaesthesia is the application of spinal and epidural
        anaesthesia together. High-dose local anaesthetics can cause significant hypotension when the
        epidural block is administered alone. The administration of spinal anaesthesia alone causes
        changes in arterial resistance, stroke volume, heart rate, cardiac output and arterial blood
        pressure. Sympathetic blockade leads to arterial vasodilation, and arterial resistance may
        decrease by 5-20% during spinal anaesthesia.
  
        Due to the increased risk of maternal complications in obese pregnant, fetal morbidity and
        mortality have increased. In addition, supine hypotension syndrome is a common problem in
        obese pregnant women. The aim of this study is to compare the change in QTc interval in obese
        and non-obese term pregnancies planned for elective cesarean section with combined spinal
        epidural anaesthesia. Thus, it is aimed to develop new protocols that will minimize cardiac
        pathologies during and after surgery in obese pregnant women.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: QTc interval
  time frame: first 2 hour starting from the time of CSE performed.
  description: The primary aim of this study was to reveal the difference in QTc interval between groups.
  arm group label: Body Mass Index≥30 kg/m2
  arm group type: Active Comparator
  description: Pregnant women with a Body Mass Index≥30 kg/m2 will be included.
  arm group label: Body Mass Index: 18,5 - 24,9 kg/m2
  arm group type: Active Comparator
  description: Pregnant women with a Body Mass Index between 18.5 and 24.9 kg/m2 will be included.
  intervention type: Other
  intervention name: BMI≥30; Combined Spinal Epidural Anesthesia
  description: Combined epidural spinal anesthesia will be performed with the loss of resistance method at constant volume and concentration ( in both patient groups. For QT interval measurements, ECG recordings will be taken before spinal anesthesia, 5 and 30 minutes after the block, and 60 and 120 minutes postoperatively.
  arm group label: Body Mass Index≥30 kg/m2
  intervention type: Other
  intervention name: BMI:18,5-24,9; Combined Spinal Epidural Anesthesia
  description: Combined epidural spinal anesthesia will be performed with the loss of resistance method at constant volume and concentration in both patient groups. For QT interval measurements, ECG recordings will be taken before spinal anesthesia, 5 and 30 minutes after the block, and 60 and 120 minutes postoperatively.
  arm group label: Body Mass Index: 18,5 - 24,9 kg/m2
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Mehmet Aksoy
  role: Study Director
  affiliation: Ataturk University
  last name: Mehmet Aksoy
  phone: +905058193526
  email: drmaksoy@hotmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  citation: Kumar T, Jha K, Sharan A, Sakshi P, Kumar S, Kumari A. Study of the effect of obesity on QT-interval among adults. J Family Med Prim Care. 2019 May;8(5):1626-1629. doi: 10.4103/jfmpc.jfmpc_168_19.
  PMID: 31198727
  citation: Song JH, Yang C, Lee W, Kim H, Kim Y, Kim H. QTc interval prolongation due to spinal anesthesia in patients with and without diabetes: an observational study. BMC Anesthesiol. 2022 May 13;22(1):143. doi: 10.1186/s12871-022-01614-8.
  PMID: 35562669
  responsible party type: Principal Investigator
  investigator affiliation: Ataturk University
  investigator full name: Mehmet AKSOY
  investigator title: Principal Investigator
  mesh term: Anesthetics
  sharing ipd: Undecided