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/NCT06022926</url>
    </required_header>
    <id_info>
      <org_study_id>11.25.2022/235</org_study_id>
      <nct_id>NCT06022926</nct_id>
    </id_info>
    <brief_title>Investigation of the Intraoperative and Postoperative Effects of Warming Patients in Laparoscopic Cholecystectomy</brief_title>
    <official_title>Effects of Patient Warming With Electric Blanket on Intraoperative Hemodynamics; Postoperative Nausea, Vomiting, Chills, Agitation and Pain in Laparoscopic Cholecystectomy Operation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Saglik Bilimleri Universitesi Gazi Yasargil Training 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>
        In our study, the investigators will investigate the effects of electric blanket heating on&#xD;
        intraoperative hemodynamics, postoperative nausea, vomiting, shivering, agitation and pain in&#xD;
        patients undergoing laparoscopic cholecystectomy under general anesthesia.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Group 1: Patients warmed with electric blankets&#xD;
  &#xD;
          -  Patients will be provided with electric blankets from the beginning to the end of the&#xD;
             operation (approximately 1 hour)&#xD;
  &#xD;
          -  all patients will receive standard general anesthesia&#xD;
  &#xD;
          -  all patients will undergo electrocardiogram, peripheral oxygen saturation by pulse&#xD;
             oximetry, non-invasive blood pressure monitoring by automatic pneumatic manometer.&#xD;
  &#xD;
          -  each patient will undergo tympanic temperature measurement immediately before induction&#xD;
             of general anesthesia, 20 minutes after induction of anesthesia, immediately after&#xD;
             extubation and during exit from the postanesthesia recovery unit.&#xD;
  &#xD;
          -  mean arterial pressure, intraoperative opioid consumption, nausea-vomiting, agitation,&#xD;
             tremor and pain assessment will be performed on each patient immediately before&#xD;
             induction of general anesthesia, 20 minutes after induction of anesthesia, immediately&#xD;
             after extubation and during discharge from the postanesthesia recovery unit.&#xD;
  &#xD;
          -  the same electric blanket was used for this group of patients&#xD;
  &#xD;
          -  each time the electric blankets were set to 38 degrees and the blankets were preheated&#xD;
             to 38 degrees approximately 30 minutes before the patients were placed on the operating&#xD;
             table.&#xD;
  &#xD;
          -  heat measurements will be made with the same tympanic heat meter device&#xD;
  &#xD;
          -  heat measurements will be made by a blind anesthesiologist with at least 5 years of&#xD;
             experience&#xD;
  &#xD;
          -  Postoperative evaluations of the patients will be performed face to face.&#xD;
  &#xD;
          -  patients will be warmed only during the time they are on the operating table&#xD;
  &#xD;
          -  This study was followed up in the operating room and post-anesthesia recovery unit in&#xD;
             the operating room.&#xD;
  &#xD;
        Group 2: Control group (patients without warming): no electric blanket will be used, and no&#xD;
        heating will be applied to this group of patients.&#xD;
  &#xD;
          -  all patients will receive standard general anesthesia.&#xD;
  &#xD;
          -  all patients will undergo electrocardiogram, peripheral oxygen saturation by pulse&#xD;
             oximetry, non-invasive blood pressure monitoring by automatic pneumatic manometer.&#xD;
  &#xD;
          -  each patient will undergo tympanic temperature measurement immediately before induction&#xD;
             of general anesthesia, 20 minutes after induction of anesthesia, immediately after&#xD;
             extubation and during exit from the postanesthesia recovery unit.&#xD;
  &#xD;
          -  mean arterial pressure, intraoperative opioid consumption, nausea-vomiting, agitation,&#xD;
             tremor and pain assessment will be performed on each patient immediately before&#xD;
             induction of general anesthesia, 20 minutes after induction of anesthesia, immediately&#xD;
             after extubation and during discharge from the postanesthesia recovery unit.&#xD;
  &#xD;
          -  temperature measurements will be performed with the same tympanic thermometer device&#xD;
  &#xD;
          -  heat measurements will be made by a blind anesthesiologist with at least 5 years of&#xD;
             experience&#xD;
  &#xD;
          -  Postoperative evaluations of the patients will be performed face to face.&#xD;
  &#xD;
          -  This study was followed up in the operating room and post-anesthesia recovery unit in&#xD;
             the operating room.&#xD;
  &#xD;
        Statistical methods / analysis: G-Power version 3.1.9.4 (University Kiel, Germany) was used&#xD;
        to calculate the sample size. Two-tailed alpha error was 0.05, power as 0.80 and effect size&#xD;
        as 0.5, and according to a previous study (Comparison of different end-tidal carbon dioxide&#xD;
        levels in preventing postoperative nausea and vomiting in gynaecological patients undergoing&#xD;
        laparoscopic surgery. Doi: 10.1080/01443615.2020.1789961.) allocation ratio was accepted as&#xD;
        N2/N1:1. The minimum number of patients to be included in the study was calculated as 128.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 11, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 29, 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>Prevention</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Agitation assessment</measure>
      <time_frame>Will be assessed from immediately after extubation until transfer from the recovery room to the ward.</time_frame>
      <description>Agitation assessment with Richmond Agitation Sedation Scale (RASS). The Richmond Agitation Sedation Scale (RASS) is a 10-point scale ranging from -5 to +4.Levels -1 to -5 denote 5 levels of sedation, starting with &quot;awakens to voice&quot; and ending with &quot;unarousable.&quot; Levels +1 to +4 describe increasing levels of agitation. The lowest level of agitation starts with apprehension and anxiety, and peaks at combative and violent. RASS level 0 is &quot;alert and calm.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pain assessment</measure>
      <time_frame>Within 30 minutes from the time the patient was extubated to the time of extubation from the postoperative recovery unit to the ward.</time_frame>
      <description>The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between &quot;no pain&quot; and &quot;worst pain.&quot;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>post-operative tremor</measure>
      <time_frame>Within 30 minutes from the time the patient was extubated to the time of extubation from the postoperative recovery unit to the ward.</time_frame>
      <description>The evaluation will be made according to this rating:&#xD;
  Grade 1: no tremor Grade 2: mild tremor with mild facial and cervical muscle contraction Grade 3: moderate tremor with obvious tremor of the head and neck, shoulders and/or extremities Grade 4: severe tremor consisting of an obvious tremor all over the body</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Amount of fentanyl consumed intraoperatively</measure>
      <time_frame>during surgery]</time_frame>
      <description>micrograms of fentanyl consumed</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Average blood pressure</measure>
      <time_frame>Assessments will be performed at 0 minutes immediately before induction of anesthesia, 20 minutes after induction, immediately after extubation and 20 minutes in the recovery unit after anesthesia.</time_frame>
      <description>Blood pressure will be measured with a non-invasive automatic pneumatic cuff in the operating theatre.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Heart rate</measure>
      <time_frame>Assessments will be performed at 0 minutes immediately before induction of anesthesia, 20 minutes after induction, immediately after extubation and 20 minutes in the recovery unit after anesthesia.</time_frame>
      <description>the measurement will be obtained by electrocardiographic monitoring</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>nausea-vomiting</measure>
      <time_frame>The evaluation will be performed at postoperative 0th hour, 2nd hour, 6th hour and 24th hour.</time_frame>
      <description>-Postoperative nausea and vomiting will be assessed using a 100 mm VAS:&#xD;
  1- severe nausea (VAS&gt;70 mm), 2- moderate nausea (50&lt;VAS&lt;70 mm), 3- mild nausea (VAS &lt;50 mm).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">128</enrollment>
    <condition>Laparoscopic Cholecystectomy</condition>
    <arm_group>
      <arm_group_label>Group 1: Patients warmed with electric blankets</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients will be provided with electric blankets from the beginning to the end of the operation (approximately 1 hour)&#xD;
  all patients will receive standard general anesthesia&#xD;
  each patient will undergo tympanic temperature measurement immediately before induction of general anesthesia, 20 minutes after induction of anesthesia, immediately after extubation and during exit from the postanesthesia recovery unit.&#xD;
  the same electric blanket was used for this group of patients&#xD;
  each time the electric blankets were set to 38 degrees and the blankets were preheated to 38 degrees approximately 30 minutes before the patients were placed on the operating table.&#xD;
  heat measurements will be made with the same tympanic heat meter device</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2: Control group (patients without warming)</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>no electric blanket will be used, and no heating will be applied to this group of patients.&#xD;
  all patients will receive standard general anesthesia&#xD;
  all patients will undergo electrocardiogram, peripheral oxygen saturation by pulse oximetry, non-invasive blood pressure monitoring by automatic pneumatic manometer&#xD;
  mean arterial pressure, intraoperative opioid consumption, nausea-vomiting, agitation, tremor and pain assessment will be performed on each patient immediately before induction of general anesthesia, 20 minutes after induction of anesthesia, immediately after extubation and during discharge from the postanesthesia recovery unit.&#xD;
  temperature measurements will be performed with the same tympanic thermometer device</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>warmed with electric blankets</intervention_name>
      <description>warmed with electric blankets</description>
      <arm_group_label>Group 1: Patients warmed with electric blankets</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>patients without warming</intervention_name>
      <description>patients without warming: no electric blanket will be used, and no heating will be applied to this group of patients.</description>
      <arm_group_label>Group 2: Control group (patients without warming)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Laparoscopic cholecystectomy operation will be&#xD;
  &#xD;
            -  To be between 18-65 years old.&#xD;
  &#xD;
            -  Being American Society of Anesthesiologists (ASA) Classification I-II.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Preoperative body temperature &gt;37.5°C or &lt;36°C.&#xD;
  &#xD;
            -  Impaired temperature regulation such as systemic infection, mental retardation,&#xD;
               isolated head trauma or brain injury.&#xD;
  &#xD;
            -  Receiving a medication that affects thermoregulation.&#xD;
  &#xD;
            -  Being American Society of Anesthesiologists (ASA) Classification &gt;III.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Days</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Cem K. Kaçar, Assoc.Prof</last_name>
      <role>Study Director</role>
      <affiliation>Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Fatma Acil, M.D.</last_name>
      <phone>+905337225225</phone>
      <email>acilfatma@gmail.com</email>
    </overall_contact>
    <reference>
      <citation>Tanaka N, Ohno Y, Hori M, Utada M, Ito K, Suzuki T. A randomised controlled trial of the resistive heating blanket versus the convective warming system for preventing hypothermia during major abdominal surgery. J Perioper Pract. 2013 Apr;23(4):82-6. doi: 10.1177/175045891302300404.</citation>
      <PMID>23691884</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital</investigator_affiliation>
      <investigator_full_name>Fatma Acil</investigator_full_name>
      <investigator_title>Anesthesiology and Reanimation Spesialist</investigator_title>
    </responsible_party>
    <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/NCT06022926
  org study id: 11.25.2022/235
  nct id: NCT06022926
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In our study, the investigators will investigate the effects of electric blanket heating on
        intraoperative hemodynamics, postoperative nausea, vomiting, shivering, agitation and pain in
        patients undergoing laparoscopic cholecystectomy under general anesthesia.
  Group 1: Patients warmed with electric blankets
  
          -  Patients will be provided with electric blankets from the beginning to the end of the
             operation (approximately 1 hour)
  
          -  all patients will receive standard general anesthesia
  
          -  all patients will undergo electrocardiogram, peripheral oxygen saturation by pulse
             oximetry, non-invasive blood pressure monitoring by automatic pneumatic manometer.
  
          -  each patient will undergo tympanic temperature measurement immediately before induction
             of general anesthesia, 20 minutes after induction of anesthesia, immediately after
             extubation and during exit from the postanesthesia recovery unit.
  
          -  mean arterial pressure, intraoperative opioid consumption, nausea-vomiting, agitation,
             tremor and pain assessment will be performed on each patient immediately before
             induction of general anesthesia, 20 minutes after induction of anesthesia, immediately
             after extubation and during discharge from the postanesthesia recovery unit.
  
          -  the same electric blanket was used for this group of patients
  
          -  each time the electric blankets were set to 38 degrees and the blankets were preheated
             to 38 degrees approximately 30 minutes before the patients were placed on the operating
             table.
  
          -  heat measurements will be made with the same tympanic heat meter device
  
          -  heat measurements will be made by a blind anesthesiologist with at least 5 years of
             experience
  
          -  Postoperative evaluations of the patients will be performed face to face.
  
          -  patients will be warmed only during the time they are on the operating table
  
          -  This study was followed up in the operating room and post-anesthesia recovery unit in
             the operating room.
  
        Group 2: Control group (patients without warming): no electric blanket will be used, and no
        heating will be applied to this group of patients.
  
          -  all patients will receive standard general anesthesia.
  
          -  all patients will undergo electrocardiogram, peripheral oxygen saturation by pulse
             oximetry, non-invasive blood pressure monitoring by automatic pneumatic manometer.
  
          -  each patient will undergo tympanic temperature measurement immediately before induction
             of general anesthesia, 20 minutes after induction of anesthesia, immediately after
             extubation and during exit from the postanesthesia recovery unit.
  
          -  mean arterial pressure, intraoperative opioid consumption, nausea-vomiting, agitation,
             tremor and pain assessment will be performed on each patient immediately before
             induction of general anesthesia, 20 minutes after induction of anesthesia, immediately
             after extubation and during discharge from the postanesthesia recovery unit.
  
          -  temperature measurements will be performed with the same tympanic thermometer device
  
          -  heat measurements will be made by a blind anesthesiologist with at least 5 years of
             experience
  
          -  Postoperative evaluations of the patients will be performed face to face.
  
          -  This study was followed up in the operating room and post-anesthesia recovery unit in
             the operating room.
  
        Statistical methods / analysis: G-Power version 3.1.9.4 (University Kiel, Germany) was used
        to calculate the sample size. Two-tailed alpha error was 0.05, power as 0.80 and effect size
        as 0.5, and according to a previous study (Comparison of different end-tidal carbon dioxide
        levels in preventing postoperative nausea and vomiting in gynaecological patients undergoing
        laparoscopic surgery. Doi: 10.1080/01443615.2020.1789961.) allocation ratio was accepted as
        N2/N1:1. The minimum number of patients to be included in the study was calculated as 128.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Participant, Outcomes Assessor)
  measure: Agitation assessment
  time frame: Will be assessed from immediately after extubation until transfer from the recovery room to the ward.
  description: Agitation assessment with Richmond Agitation Sedation Scale (RASS). The Richmond Agitation Sedation Scale (RASS) is a 10-point scale ranging from -5 to +4.Levels -1 to -5 denote 5 levels of sedation, starting with "awakens to voice" and ending with "unarousable." Levels +1 to +4 describe increasing levels of agitation. The lowest level of agitation starts with apprehension and anxiety, and peaks at combative and violent. RASS level 0 is "alert and calm.
  measure: Pain assessment
  time frame: Within 30 minutes from the time the patient was extubated to the time of extubation from the postoperative recovery unit to the ward.
  description: The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
  measure: post-operative tremor
  time frame: Within 30 minutes from the time the patient was extubated to the time of extubation from the postoperative recovery unit to the ward.
  description: The evaluation will be made according to this rating:
  Grade 1: no tremor Grade 2: mild tremor with mild facial and cervical muscle contraction Grade 3: moderate tremor with obvious tremor of the head and neck, shoulders and/or extremities Grade 4: severe tremor consisting of an obvious tremor all over the body
  measure: Amount of fentanyl consumed intraoperatively
  time frame: during surgery]
  description: micrograms of fentanyl consumed
  measure: Average blood pressure
  time frame: Assessments will be performed at 0 minutes immediately before induction of anesthesia, 20 minutes after induction, immediately after extubation and 20 minutes in the recovery unit after anesthesia.
  description: Blood pressure will be measured with a non-invasive automatic pneumatic cuff in the operating theatre.
  measure: Heart rate
  time frame: Assessments will be performed at 0 minutes immediately before induction of anesthesia, 20 minutes after induction, immediately after extubation and 20 minutes in the recovery unit after anesthesia.
  description: the measurement will be obtained by electrocardiographic monitoring
  measure: nausea-vomiting
  time frame: The evaluation will be performed at postoperative 0th hour, 2nd hour, 6th hour and 24th hour.
  description: -Postoperative nausea and vomiting will be assessed using a 100 mm VAS:
  1- severe nausea (VAS>70 mm), 2- moderate nausea (50<VAS<70 mm), 3- mild nausea (VAS <50 mm).
  arm group label: Group 1: Patients warmed with electric blankets
  arm group type: Active Comparator
  description: Patients will be provided with electric blankets from the beginning to the end of the operation (approximately 1 hour)
  all patients will receive standard general anesthesia
  each patient will undergo tympanic temperature measurement immediately before induction of general anesthesia, 20 minutes after induction of anesthesia, immediately after extubation and during exit from the postanesthesia recovery unit.
  the same electric blanket was used for this group of patients
  each time the electric blankets were set to 38 degrees and the blankets were preheated to 38 degrees approximately 30 minutes before the patients were placed on the operating table.
  heat measurements will be made with the same tympanic heat meter device
  arm group label: Group 2: Control group (patients without warming)
  arm group type: Other
  description: no electric blanket will be used, and no heating will be applied to this group of patients.
  all patients will receive standard general anesthesia
  all patients will undergo electrocardiogram, peripheral oxygen saturation by pulse oximetry, non-invasive blood pressure monitoring by automatic pneumatic manometer
  mean arterial pressure, intraoperative opioid consumption, nausea-vomiting, agitation, tremor and pain assessment will be performed on each patient immediately before induction of general anesthesia, 20 minutes after induction of anesthesia, immediately after extubation and during discharge from the postanesthesia recovery unit.
  temperature measurements will be performed with the same tympanic thermometer device
  intervention type: Procedure
  intervention name: warmed with electric blankets
  description: warmed with electric blankets
  arm group label: Group 1: Patients warmed with electric blankets
  intervention type: Other
  intervention name: patients without warming
  description: patients without warming: no electric blanket will be used, and no heating will be applied to this group of patients.
  arm group label: Group 2: Control group (patients without warming)
  criteria: 
  gender: All
  minimum age: 18 Days
  maximum age: 65 Years
  healthy volunteers: No
  last name: Cem K. Kaçar, Assoc.Prof
  role: Study Director
  affiliation: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
  last name: Fatma Acil, M.D.
  phone: +905337225225
  email: acilfatma@gmail.com
  citation: Tanaka N, Ohno Y, Hori M, Utada M, Ito K, Suzuki T. A randomised controlled trial of the resistive heating blanket versus the convective warming system for preventing hypothermia during major abdominal surgery. J Perioper Pract. 2013 Apr;23(4):82-6. doi: 10.1177/175045891302300404.
  PMID: 23691884
  responsible party type: Principal Investigator
  investigator affiliation: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
  investigator full name: Fatma Acil
  investigator title: Anesthesiology and Reanimation Spesialist
  sharing ipd: Undecided