<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/NCT03818048</url>
  </required_header>
  <id_info>
    <org_study_id>CMDLT</org_study_id>
    <nct_id>NCT03818048</nct_id>
  </id_info>
  <brief_title>Inhaled Sevofluran vs Endovenous Propofol for Colonoscopy</brief_title>
  <official_title>Inhaled Sevofluran vs Endovenous Propofol for Sedation Maintenance in Patients Submitted to Colonoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centro Medico Docente la Trinidad</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centro Medico Docente la Trinidad</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare the anesthetic efficacy of the inhalation versus intravenous technique for&#xD;
      maintenance of sedation in patients undergoing endoscopy.&#xD;
&#xD;
      A longitudinal, randomized clinical study of 32 patients of both sexes ASA I-III, aged 18-80&#xD;
      years undergoing diagnostic colonoscopy, which was randomly divided into 2 groups. In both,&#xD;
      intravenous induction with propofol (2-2.5 mg / kg) was performed, Group A remained sedated&#xD;
      with propofol infusion (1-2 mg / kg / min); Group B by inhalation with sevoflurane at a&#xD;
      concentration of 2 vol% through a nasal cannula with an oxygen flow.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Actual">December 28, 2016</completion_date>
  <primary_completion_date type="Actual">October 1, 2016</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>Supportive Care</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Heart rate</measure>
    <time_frame>During the colonoscopy - an estimated mean time of 20 minutes</time_frame>
    <description>heart rate per minute</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Recovery Time</measure>
    <time_frame>30 min</time_frame>
    <description>Every 5 minutes till a score of 10/10 achieved on Aldrete Score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Propofol dosage</measure>
    <time_frame>During the colonoscopy - an estimated mean time of 20 minutes</time_frame>
    <description>propofol rescate bolus administered</description>
  </primary_outcome>
  <primary_outcome>
    <measure>arterial pressure</measure>
    <time_frame>During the colonoscopy - an estimated mean time of 20 minutes</time_frame>
    <description>non invasive arterial pressure every 5 minutes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>oxygen saturation</measure>
    <time_frame>During the colonoscopy - an estimated mean time of 20 minutes</time_frame>
    <description>pulse oximetry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>adverse reactions in patients</measure>
    <time_frame>1 day (postoperative)</time_frame>
    <description>desaturation, laryngospasm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endoscopist Satisfaction</measure>
    <time_frame>60 min</time_frame>
    <description>Endoscopist Satisfaction scored from 1-10. Will be tested on a numerical scale from 0 (not satisfied at all) to 10 (fully satisfied)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Qualitatively assess patient comfort after sedation.</measure>
    <time_frame>Up to 1 hour after completing the study.</time_frame>
    <description>poor, regular or good</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Group Propofol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>propofol infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group Sevoflurane</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>inhalation with sevoflurane</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>after inicial bolus of propofol, remained sedated with propofol infusion (1-2 mg/kg/min)</description>
    <arm_group_label>Group Propofol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sevoflurane</intervention_name>
    <description>after inicial bolus of propofol, remained sedated by inhalation with sevoflurane at a concentration of 2 vol% through a nasal cannula with an oxygen flow.</description>
    <arm_group_label>Group Sevoflurane</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18 and 80 years&#xD;
&#xD;
          -  physical status I, II and III according to the criteria of the American Society of&#xD;
             Anesthesiology (ASA)&#xD;
&#xD;
          -  patients who are going to undergo diagnostic colonoscopies&#xD;
&#xD;
          -  patients who signed the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy or hypersensitivity to some of the reference drugs in the study&#xD;
&#xD;
          -  patients with proven liver disease&#xD;
&#xD;
          -  suspicion or confirmation of pregnancy&#xD;
&#xD;
          -  antecedent or risk of malignant hyperthermia&#xD;
&#xD;
          -  fasting less than 8 hours&#xD;
&#xD;
          -  patients with psychic disorders or mental incapacity that make it difficult to&#xD;
             understand their participation in the study&#xD;
&#xD;
          -  patients who have acute illnesses that compromise their health for which the study&#xD;
             cannot be performed&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>January 23, 2019</last_update_submitted>
  <last_update_submitted_qc>January 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centro Medico Docente la Trinidad</investigator_affiliation>
    <investigator_full_name>Leopoldo Wulff</investigator_full_name>
    <investigator_title>Principal Investigator, anesthesiologist.</investigator_title>
  </responsible_party>
  <keyword>sedation</keyword>
  <keyword>colonoscopy</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propofol</mesh_term>
    <mesh_term>Sevoflurane</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03818048
org study id: CMDLT
nct id: NCT03818048
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
To compare the anesthetic efficacy of the inhalation versus intravenous technique for
      maintenance of sedation in patients undergoing endoscopy.

      A longitudinal, randomized clinical study of 32 patients of both sexes ASA I-III, aged 18-80
      years undergoing diagnostic colonoscopy, which was randomly divided into 2 groups. In both,
      intravenous induction with propofol (2-2.5 mg / kg) was performed, Group A remained sedated
      with propofol infusion (1-2 mg / kg / min); Group B by inhalation with sevoflurane at a
      concentration of 2 vol% through a nasal cannula with an oxygen flow.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Outcomes Assessor)
measure: Heart rate
time frame: During the colonoscopy - an estimated mean time of 20 minutes
description: heart rate per minute
measure: The Recovery Time
time frame: 30 min
description: Every 5 minutes till a score of 10/10 achieved on Aldrete Score
measure: Propofol dosage
time frame: During the colonoscopy - an estimated mean time of 20 minutes
description: propofol rescate bolus administered
measure: arterial pressure
time frame: During the colonoscopy - an estimated mean time of 20 minutes
description: non invasive arterial pressure every 5 minutes
measure: oxygen saturation
time frame: During the colonoscopy - an estimated mean time of 20 minutes
description: pulse oximetry
measure: adverse reactions in patients
time frame: 1 day (postoperative)
description: desaturation, laryngospasm
measure: Endoscopist Satisfaction
time frame: 60 min
description: Endoscopist Satisfaction scored from 1-10. Will be tested on a numerical scale from 0 (not satisfied at all) to 10 (fully satisfied)
measure: Qualitatively assess patient comfort after sedation.
time frame: Up to 1 hour after completing the study.
description: poor, regular or good
arm group label: Group Propofol
arm group type: Experimental
description: propofol infusion
arm group label: Group Sevoflurane
arm group type: Experimental
description: inhalation with sevoflurane
intervention type: Drug
intervention name: Propofol
description: after inicial bolus of propofol, remained sedated with propofol infusion (1-2 mg/kg/min)
arm group label: Group Propofol
intervention type: Drug
intervention name: Sevoflurane
description: after inicial bolus of propofol, remained sedated by inhalation with sevoflurane at a concentration of 2 vol% through a nasal cannula with an oxygen flow.
arm group label: Group Sevoflurane
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Centro Medico Docente la Trinidad
investigator full name: Leopoldo Wulff
investigator title: Principal Investigator, anesthesiologist.
mesh term: Propofol
mesh term: Sevoflurane
sharing ipd: No