<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/NCT02209883</url>
  </required_header>
  <id_info>
    <org_study_id>sevofluorane washout time COPD</org_study_id>
    <nct_id>NCT02209883</nct_id>
  </id_info>
  <brief_title>The Effect of Sevofluorane on Wash-out Time in COPD</brief_title>
  <acronym>washout</acronym>
  <official_title>The Effects of Chronic Obstructive Pulmonary Disease on the Washout Time of Sevofluorane Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duzce University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duzce University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      COPD (Chronic obstructive disease ) is a condition of respiratory system failure seen&#xD;
      occasionally in elderly patients of society. Sevofluorane is a safe, volatile anesthetic used&#xD;
      considerably widely all over the world. Because respiratory functions and gas exchange became&#xD;
      impaired in COPD patients, the respiratory system excretion/washout of inhalational&#xD;
      anesthetic agents can be affected. In our study we aimed to investigate if there is a&#xD;
      relation between sevofluorane's washout time and the degree of COPD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Having approval by the Duzce University non-invasive clinical ethics committee and the&#xD;
      written consent, the study was conducted by researchers among 60 American Society of&#xD;
      Anesthesiologists (ASA) physical status 1 or 2 patients scheduled for orthopedic, urologic&#xD;
      and lower limp surgery which performed under general anesthesia .We investigated patients who&#xD;
      have normal pulmonary function and who have chronic obstructive pulmonary disease .We divided&#xD;
      into two groups by via questioning and evaluating pulmonary function tests of patients.&#xD;
&#xD;
      The patients were 18-60 years old, with body mass index between 22-29. The exclusion criteria&#xD;
      were:&#xD;
&#xD;
        1. Cardiac failure&#xD;
&#xD;
        2. Hepatic failure&#xD;
&#xD;
        3. Renal failure&#xD;
&#xD;
        4. Neurologic diseases&#xD;
&#xD;
        5. Endocrine diseases Study design Neither group received premedication. After being taken&#xD;
           to the operating room all patients were monitored continuously throughout the study by&#xD;
           standard ASA monitors. In addition to standard ASA monitors, inspired oxygen&#xD;
           concentration (FiO2 ), inspired and expired concentration of sevofluorane, MAC levels of&#xD;
           the patients were monitored.&#xD;
&#xD;
      Anesthesia was induced by propofol (2mg . kg-1), fentanyl (1,5-2 mcg. kg-1),&#xD;
      rocuronium(0,6mg. kg-1) intravenously. General anesthesia was maintained by remifentanyl&#xD;
      infusion(0,25-1 mcg.kg-1.min-1) and sevofluorane (1 MAC level corrected for the patients&#xD;
      age). Fresh gas flow was 6 L. min-1 (50%-50% oxygen/air mixture). Patients were mechanically&#xD;
      ventilated (Vt: 6-8 ml. kg-1 , frequency: 9-12 breath.min-1), adjusted to provide an&#xD;
      end-tidal CO2 concentration of 35-40 mmHg and SpO2&gt; %95 during anesthetic and surgical&#xD;
      procedure.The patients non-invasive arterial tension and heart rate was maintain within&#xD;
      normal limits. All data were recorded on each patient's observation charts.&#xD;
&#xD;
      At the end of the surgery, the sevofluorane vaporizer was turned off and the time taken for&#xD;
      the sevofluorane concentration to decrease from 1 MAC to 0.3 MAC (MAC awake) and 0.1 MAC were&#xD;
      recorded. The ratio of the fraction of inspired of sevoflurane and of expired concentration&#xD;
      (Fexp) of sevofluorane at 1 MAC and Fexp of sevofluorane at 0.1 MAC were recorded. Mechanical&#xD;
      ventilations of the patients were maintained until extubation and standardized according to&#xD;
      ideal body weight. All patients extubated immediately after the patients were given reaction&#xD;
      to the endotracheal tube. Remifetanyl infusion was maintained until 0.1 MAC level was&#xD;
      reached.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>washout time</measure>
    <time_frame>second</time_frame>
    <description>The time in which sevoflurane MAC level decrease from 0.3 MAC to 0.1MAC and 0,1 MAC to extubation in the patients expiratory gases</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>extubation time</measure>
    <time_frame>seconds</time_frame>
    <description>The time which sevoflurane MAC level decrease 1 MAC to extubation</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Group normal</arm_group_label>
    <description>The patients which have not clinical diagnosis of chronic obstructive lung disease.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group COPD</arm_group_label>
    <description>The patients which have chronic obstructive lung disease in clinical evaluation</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        the study was conducted by reserchers among 60 American Society of Anesthesiologists (ASA)&#xD;
        physical status 1 or 2 patients scheduled for orthopedic, urologic and lower limp surgery&#xD;
        which performed under general anesthesia .We investigated patientes who have normal&#xD;
        pulmonary function and who have chronic obstructive pulmonary disease .We divided into two&#xD;
        groups by via questioning and evaluating pulmonary function tests of patients.&#xD;
&#xD;
        The patients were 18-60 years old, with body mass index between 22-29&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Anesthesiologists (ASA) physical status 1 or 2 patients&#xD;
&#xD;
          -  orthopedic, urologic and lower limp surgery which performed under general anesthesia&#xD;
&#xD;
          -  normal pulmonary function&#xD;
&#xD;
          -  chronic obstructive pulmonary disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiac failure&#xD;
&#xD;
          -  Hepatic failure&#xD;
&#xD;
          -  Renal failure&#xD;
&#xD;
          -  Neurologic diseases&#xD;
&#xD;
          -  Endocrine diseases&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ilknur Suidiye Seker, Asist. prof.</last_name>
    <role>Study Director</role>
    <affiliation>Duzce University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duzce Univercity Medical Fauculty</name>
      <address>
        <city>Duzce</city>
        <zip>81620</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2905413/</url>
    <description>PMC full text</description>
  </link>
  <reference>
    <citation>Adanir T, Atay A, Sencan A, Aksun M, Karahan N. Effect of cigarette smoking on the washout time of sevoflurane anesthesia. BMC Anesthesiol. 2010 Jun 22;10:8. doi: 10.1186/1471-2253-10-8.</citation>
    <PMID>20569431</PMID>
  </reference>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>August 5, 2015</last_update_submitted>
  <last_update_submitted_qc>August 5, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 6, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Duzce University</investigator_affiliation>
    <investigator_full_name>Ilknur Suidiye</investigator_full_name>
    <investigator_title>Assistant profesor</investigator_title>
  </responsible_party>
  <keyword>sevoflurane, anesthesia, washout time,COPD</keyword>
  <!-- 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/NCT02209883
org study id: sevofluorane washout time COPD
nct id: NCT02209883
lead sponsor: 
has dmc: No
COPD (Chronic obstructive disease ) is a condition of respiratory system failure seen
      occasionally in elderly patients of society. Sevofluorane is a safe, volatile anesthetic used
      considerably widely all over the world. Because respiratory functions and gas exchange became
      impaired in COPD patients, the respiratory system excretion/washout of inhalational
      anesthetic agents can be affected. In our study we aimed to investigate if there is a
      relation between sevofluorane's washout time and the degree of COPD.
Having approval by the Duzce University non-invasive clinical ethics committee and the
      written consent, the study was conducted by researchers among 60 American Society of
      Anesthesiologists (ASA) physical status 1 or 2 patients scheduled for orthopedic, urologic
      and lower limp surgery which performed under general anesthesia .We investigated patients who
      have normal pulmonary function and who have chronic obstructive pulmonary disease .We divided
      into two groups by via questioning and evaluating pulmonary function tests of patients.

      The patients were 18-60 years old, with body mass index between 22-29. The exclusion criteria
      were:

        1. Cardiac failure

        2. Hepatic failure

        3. Renal failure

        4. Neurologic diseases

        5. Endocrine diseases Study design Neither group received premedication. After being taken
           to the operating room all patients were monitored continuously throughout the study by
           standard ASA monitors. In addition to standard ASA monitors, inspired oxygen
           concentration (FiO2 ), inspired and expired concentration of sevofluorane, MAC levels of
           the patients were monitored.

      Anesthesia was induced by propofol (2mg . kg-1), fentanyl (1,5-2 mcg. kg-1),
      rocuronium(0,6mg. kg-1) intravenously. General anesthesia was maintained by remifentanyl
      infusion(0,25-1 mcg.kg-1.min-1) and sevofluorane (1 MAC level corrected for the patients
      age). Fresh gas flow was 6 L. min-1 (50%-50% oxygen/air mixture). Patients were mechanically
      ventilated (Vt: 6-8 ml. kg-1 , frequency: 9-12 breath.min-1), adjusted to provide an
      end-tidal CO2 concentration of 35-40 mmHg and SpO2> %95 during anesthetic and surgical
      procedure.The patients non-invasive arterial tension and heart rate was maintain within
      normal limits. All data were recorded on each patient's observation charts.

      At the end of the surgery, the sevofluorane vaporizer was turned off and the time taken for
      the sevofluorane concentration to decrease from 1 MAC to 0.3 MAC (MAC awake) and 0.1 MAC were
      recorded. The ratio of the fraction of inspired of sevoflurane and of expired concentration
      (Fexp) of sevofluorane at 1 MAC and Fexp of sevofluorane at 0.1 MAC were recorded. Mechanical
      ventilations of the patients were maintained until extubation and standardized according to
      ideal body weight. All patients extubated immediately after the patients were given reaction
      to the endotracheal tube. Remifetanyl infusion was maintained until 0.1 MAC level was
      reached.
observational model: Cohort
time perspective: Prospective
measure: washout time
time frame: second
description: The time in which sevoflurane MAC level decrease from 0.3 MAC to 0.1MAC and 0,1 MAC to extubation in the patients expiratory gases
measure: extubation time
time frame: seconds
description: The time which sevoflurane MAC level decrease 1 MAC to extubation
arm group label: Group normal
description: The patients which have not clinical diagnosis of chronic obstructive lung disease.
arm group label: Group COPD
description: The patients which have chronic obstructive lung disease in clinical evaluation
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ilknur Suidiye Seker, Asist. prof.
role: Study Director
affiliation: Duzce University School of Medicine
facility: 
country: Turkey
url: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2905413/
description: PMC full text
citation: Adanir T, Atay A, Sencan A, Aksun M, Karahan N. Effect of cigarette smoking on the washout time of sevoflurane anesthesia. BMC Anesthesiol. 2010 Jun 22;10:8. doi: 10.1186/1471-2253-10-8.
PMID: 20569431
responsible party type: Principal Investigator
investigator affiliation: Duzce University
investigator full name: Ilknur Suidiye
investigator title: Assistant profesor