<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/NCT02226328</url>
  </required_header>
  <id_info>
    <org_study_id>2013-004358-12</org_study_id>
    <nct_id>NCT02226328</nct_id>
  </id_info>
  <brief_title>Nurse Administered Propofol Sedation vs. Midazolam With Fentanyl-sedation for Flexible Bronchoscopy: A Randomized, Single Blind, Controlled Study of Satisfaction and Safety.</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Copenhagen University Hospital at Herlev</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Copenhagen University Hospital at Herlev</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Flexible bronchoscopy almost always requires sedation to be successful. In order to increase&#xD;
      the availability of propofol for sedation, non-anaesthesiologist administered propofol&#xD;
      sedation has been suggested as an alternative to traditional midazolam/opioid sedation or the&#xD;
      general anaesthesia provided by anaesthesiologists.&#xD;
&#xD;
      Hypothesis: Patients undergoing flexible bronchoscopy prefers non-anaesthesiologist&#xD;
      administered sedation with propofol as opposed to non-anaesthesiologist administered sedation&#xD;
      with midazolam and fentanyl.&#xD;
&#xD;
      Propofol sedation is as safe as midazolam and fentanyl sedation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2014</start_date>
  <completion_date type="Anticipated">April 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2015</primary_completion_date>
  <phase>Phase 4</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Satisfaction with sedation</measure>
    <time_frame>At discharge, on average 30 minutes after procedure termination.</time_frame>
    <description>The average duration of bronchoscopy is estimated to 20 minutes. A validated satisfaction questionnaire will be filled by the patient at discharge from the recovery room, on average 30 minutes after completed procedure. Readiness for discharge will be assessed using an Aldrete score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events as a surrogate marker of safety.</measure>
    <time_frame>During procedure. On average 20 minutes.</time_frame>
    <description>Adverse events as a dichotomous value of &quot;no event&quot; or &quot;event&quot;. Events are: The use of rescue medicine, and cardiopulmonary support per-operatively, blood pressure deviation from baseline over 30% of Mean Arterial Pressure, oxygen saturation &lt; 90%, and arrhythmias will be recorded for the duration of the procedure.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient comfort</measure>
    <time_frame>Per-operatively, on average 20 minutes</time_frame>
    <description>Patient discomfort/comfort will be registered on a validated scale during the procedure and recorded by the endoscopy nurse. If the procedure was unsuccessful due to discomfort, this will also be recorded.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">128</enrollment>
  <condition>Flexible Bronchoscopy</condition>
  <condition>Sedation</condition>
  <condition>Satisfaction</condition>
  <condition>Safety</condition>
  <arm_group>
    <arm_group_label>Propofol sedation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Refract bolus propofol sedation as monotherapy administered by a sedation-trained nurse endoscopist.&#xD;
Induction with 10-60 mg bolus, repeated every 45-60 sec. until moderate sedation.&#xD;
Maintenance with 10-20 mg of propofol in case of discomfort.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Midazolam and Fentanyl sedation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1-2 mg of Midazolam with 0.025-0.05 mg of fentanyl for induction 10 prior to procedure initiation.&#xD;
Maintenance with 1 mg Midazolam in case of discomfort.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol sedation</intervention_name>
    <arm_group_label>Propofol sedation</arm_group_label>
    <other_name>ATC code: N01AX10</other_name>
    <other_name>CAS no: 2078-54-8</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Midazolam and Fentanyl sedation</intervention_name>
    <arm_group_label>Midazolam and Fentanyl sedation</arm_group_label>
    <other_name>Midazolam:</other_name>
    <other_name>ATC code: N05CD08</other_name>
    <other_name>CAS no: 59467-70-8</other_name>
    <other_name>Fentanyl:</other_name>
    <other_name>ATC code: N01AH01</other_name>
    <other_name>CAS no: 437-38-7</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Elective flexible bronchoscopy.&#xD;
&#xD;
          2. Willing to be randomised&#xD;
&#xD;
          3. Provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Allergy to contents administered&#xD;
&#xD;
          2. pregnant or nursing&#xD;
&#xD;
          3. &lt;18 years of age&#xD;
&#xD;
          4. Not able to complete questionnaire&#xD;
&#xD;
          5. Acute condition&#xD;
&#xD;
          6. severe COPD&#xD;
&#xD;
          7. &gt; ASA II&#xD;
&#xD;
          8. Sleep apnea&#xD;
&#xD;
          9. Risk of aspiration&#xD;
&#xD;
         10. Previously difficulty with anesthesia&#xD;
&#xD;
         11. Difficult airway&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul F Clementsen, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Copenhagen at Gentofte Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jeppe Thue Jensen, MD</last_name>
    <phone>004526136032</phone>
    <email>jeppe.thue.jensen.01@regionh.dk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Paul F Clementsen, Professor</last_name>
    <phone>0045 39 77 39 77</phone>
    <email>paul.clementsen@regionh.dk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Gentofte Hospital</name>
      <address>
        <city>Hellerup</city>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Paul F Clementsen, Professor</last_name>
      <phone>0045 39 77 39 77</phone>
      <email>paul.clementsen@regionh.dk</email>
    </contact>
    <investigator>
      <last_name>Paul Clementsen, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Valentina Minddal, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>June 29, 2015</last_update_submitted>
  <last_update_submitted_qc>June 29, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 30, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Midazolam</mesh_term>
    <mesh_term>Propofol</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02226328
org study id: 2013-004358-12
nct id: NCT02226328
lead sponsor: 
has dmc: Yes
Flexible bronchoscopy almost always requires sedation to be successful. In order to increase
      the availability of propofol for sedation, non-anaesthesiologist administered propofol
      sedation has been suggested as an alternative to traditional midazolam/opioid sedation or the
      general anaesthesia provided by anaesthesiologists.

      Hypothesis: Patients undergoing flexible bronchoscopy prefers non-anaesthesiologist
      administered sedation with propofol as opposed to non-anaesthesiologist administered sedation
      with midazolam and fentanyl.

      Propofol sedation is as safe as midazolam and fentanyl sedation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Satisfaction with sedation
time frame: At discharge, on average 30 minutes after procedure termination.
description: The average duration of bronchoscopy is estimated to 20 minutes. A validated satisfaction questionnaire will be filled by the patient at discharge from the recovery room, on average 30 minutes after completed procedure. Readiness for discharge will be assessed using an Aldrete score.
measure: Number of adverse events as a surrogate marker of safety.
time frame: During procedure. On average 20 minutes.
description: Adverse events as a dichotomous value of "no event" or "event". Events are: The use of rescue medicine, and cardiopulmonary support per-operatively, blood pressure deviation from baseline over 30% of Mean Arterial Pressure, oxygen saturation < 90%, and arrhythmias will be recorded for the duration of the procedure.
measure: Patient comfort
time frame: Per-operatively, on average 20 minutes
description: Patient discomfort/comfort will be registered on a validated scale during the procedure and recorded by the endoscopy nurse. If the procedure was unsuccessful due to discomfort, this will also be recorded.
arm group label: Propofol sedation
arm group type: Experimental
description: Refract bolus propofol sedation as monotherapy administered by a sedation-trained nurse endoscopist.
Induction with 10-60 mg bolus, repeated every 45-60 sec. until moderate sedation.
Maintenance with 10-20 mg of propofol in case of discomfort.
arm group label: Midazolam and Fentanyl sedation
arm group type: Active Comparator
description: 1-2 mg of Midazolam with 0.025-0.05 mg of fentanyl for induction 10 prior to procedure initiation.
Maintenance with 1 mg Midazolam in case of discomfort.
intervention type: Drug
intervention name: Propofol sedation
arm group label: Propofol sedation
other name: ATC code: N01AX10
other name: CAS no: 2078-54-8
intervention type: Drug
intervention name: Midazolam and Fentanyl sedation
arm group label: Midazolam and Fentanyl sedation
other name: Midazolam:
other name: ATC code: N05CD08
other name: CAS no: 59467-70-8
other name: Fentanyl:
other name: ATC code: N01AH01
other name: CAS no: 437-38-7
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paul F Clementsen, Professor
role: Principal Investigator
affiliation: University of Copenhagen at Gentofte Hospital
last name: Jeppe Thue Jensen, MD
phone: 004526136032
email: jeppe.thue.jensen.01@regionh.dk
last name: Paul F Clementsen, Professor
phone: 0045 39 77 39 77
email: paul.clementsen@regionh.dk
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Denmark
responsible party type: Sponsor
mesh term: Fentanyl
mesh term: Midazolam
mesh term: Propofol