<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/NCT02249364</url>
  </required_header>
  <id_info>
    <org_study_id>2013/49</org_study_id>
    <secondary_id>2013-A01640-45</secondary_id>
    <nct_id>NCT02249364</nct_id>
    <nct_alias>NCT02296827</nct_alias>
  </id_info>
  <brief_title>Hypnosis Before the Induction of Anesthesia</brief_title>
  <acronym>Hypnose2</acronym>
  <official_title>Interest of Hypnosis Before the Induction of Anesthesia. Study in Women Submitted to One Day Gynecological Surgical Procedures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hopital Foch</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hopital Foch</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypnosis may reduce patient anxiety. The main goal of this study is to determine in what&#xD;
      extent, hypnosis decreases propofol requirement to induce induction of general anesthesia.&#xD;
&#xD;
      Two particular aspects of this study are&#xD;
&#xD;
        -  the inclusion of women undergoing one day gynecological surgical procedures&#xD;
&#xD;
        -  the use of a closed-loop system which delivers propofol according to bispectral index to&#xD;
           provide induction of anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Administered dose of propofol</measure>
    <time_frame>one hour</time_frame>
    <description>Administered dose of propofol required to obtain the induction of anesthesia (bispectral index &lt;60 for at least 30 seconds)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Target plasma concentration of propofol</measure>
    <time_frame>one hour</time_frame>
    <description>Target plasma concentration of propofol corresponding to induction of anesthesia (bispectral index &lt;60 for at least 30 seconds)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain of insertion of peripheral vein catheter</measure>
    <time_frame>one hour</time_frame>
    <description>Pain is assessed by two criteria:&#xD;
withdrawal of the arm perfused (no = 0; withdrawal = 1; violent withdrawal = 2),&#xD;
spontaneous expression (no = 0; frown = 1; grin or verbal complaint = 2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain due to injection of propofol</measure>
    <time_frame>one hour</time_frame>
    <description>Pain is assessed by two criteria:&#xD;
withdrawal of the arm perfused (no = 0; withdrawal = 1; violent withdrawal = 2),&#xD;
spontaneous expression (no = 0; frown = 1; grin or verbal complaint = 2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of hypnosis on bispectral index</measure>
    <time_frame>one hour</time_frame>
    <description>Effect of hypnosis on bispectral index before the induction of anesthesia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to loss of consciousness</measure>
    <time_frame>one hour</time_frame>
    <description>Time between the beginning of injection of propofol and the loss of eyelash reflex</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemodynamic consequences of induction of anesthesia</measure>
    <time_frame>one hour</time_frame>
    <description>Heart rate and blood pressure are measured just before induction of anesthesia and once it is realized.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Administration of a cardio-vascular agent</measure>
    <time_frame>one hour</time_frame>
    <description>Administration of ephedrine, atropine or of an hypotensive agent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Manipulation of the airway</measure>
    <time_frame>one hour</time_frame>
    <description>Necessity of a jaw thrust maneuver or of another manipulation of the airway during the induction of anesthesia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characteristics of the hypnotic procedure evaluated by the clinician in the group &quot;hypnosis&quot;</measure>
    <time_frame>one hour</time_frame>
    <description>The hypnotic procedure is assessed by three criteria:&#xD;
receptivity of the patient (yes/no),&#xD;
rapidity of focalization procedure (very fast, fast, medium, delayed, impossible to obtain),&#xD;
quality of the hypnotic trance (very deep, deep, medium, superficial, not obtained).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characteristics of the hypnotic procedure evaluated by the patient in the group &quot;hypnosis&quot;</measure>
    <time_frame>six hours</time_frame>
    <description>The hypnotic procedure is assessed by a question : &quot;Did you visualize the memory we talked about before the session ? (yes, no )</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characteristics of the preanesthetic management evaluated by the patient (all the patients)</measure>
    <time_frame>Six hours</time_frame>
    <description>The preanesthetic management is assessed by one criteria:&quot;How do you rate the quality of the preanesthetic period (from the entrance in the operating room to the induction of the general anesthesia ?&quot; (excellent, good, average, not good)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard care without hypnosis session followed by closed-loop administration of propofol for anesthesia induction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hypnosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hypnosis session followed by closed-loop administration of propofol for anesthesia induction</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Routine practice</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hypnosis</intervention_name>
    <description>Hypnosis session before induction of anesthesia</description>
    <arm_group_label>Hypnosis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>propofol</intervention_name>
    <description>Closed-loop administration of propofol for anesthesia induction</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Hypnosis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult female patients scheduled for a one day gynecological surgical procedures under&#xD;
             general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy, breast feeding woman&#xD;
&#xD;
          -  allergy to propofol, soy or peanuts&#xD;
&#xD;
          -  history of central nervous system disease&#xD;
&#xD;
          -  psychiatric affection&#xD;
&#xD;
          -  hypovolemia, high cardiovascular risk&#xD;
&#xD;
          -  patients with a pace-maker&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marc Fischler</last_name>
    <role>Study Chair</role>
    <affiliation>Hopital Foch</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dept of Anesthesia, Hôpital Foch</name>
      <address>
        <city>Suresnes</city>
        <zip>92150</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95. doi: 10.1097/00000542-200604000-00012.</citation>
    <PMID>16571963</PMID>
  </reference>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>October 28, 2016</last_update_submitted>
  <last_update_submitted_qc>October 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 31, 2016</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>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/NCT02249364
org study id: 2013/49
secondary id: 2013-A01640-45
nct id: NCT02249364
nct alias: NCT02296827
lead sponsor: 
has dmc: No
Hypnosis may reduce patient anxiety. The main goal of this study is to determine in what
      extent, hypnosis decreases propofol requirement to induce induction of general anesthesia.

      Two particular aspects of this study are

        -  the inclusion of women undergoing one day gynecological surgical procedures

        -  the use of a closed-loop system which delivers propofol according to bispectral index to
           provide induction of anesthesia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Administered dose of propofol
time frame: one hour
description: Administered dose of propofol required to obtain the induction of anesthesia (bispectral index <60 for at least 30 seconds)
measure: Target plasma concentration of propofol
time frame: one hour
description: Target plasma concentration of propofol corresponding to induction of anesthesia (bispectral index <60 for at least 30 seconds)
measure: Pain of insertion of peripheral vein catheter
time frame: one hour
description: Pain is assessed by two criteria:
withdrawal of the arm perfused (no = 0; withdrawal = 1; violent withdrawal = 2),
spontaneous expression (no = 0; frown = 1; grin or verbal complaint = 2)
measure: Pain due to injection of propofol
time frame: one hour
description: Pain is assessed by two criteria:
withdrawal of the arm perfused (no = 0; withdrawal = 1; violent withdrawal = 2),
spontaneous expression (no = 0; frown = 1; grin or verbal complaint = 2)
measure: Effect of hypnosis on bispectral index
time frame: one hour
description: Effect of hypnosis on bispectral index before the induction of anesthesia
measure: Time to loss of consciousness
time frame: one hour
description: Time between the beginning of injection of propofol and the loss of eyelash reflex
measure: Hemodynamic consequences of induction of anesthesia
time frame: one hour
description: Heart rate and blood pressure are measured just before induction of anesthesia and once it is realized.
measure: Administration of a cardio-vascular agent
time frame: one hour
description: Administration of ephedrine, atropine or of an hypotensive agent
measure: Manipulation of the airway
time frame: one hour
description: Necessity of a jaw thrust maneuver or of another manipulation of the airway during the induction of anesthesia
measure: Characteristics of the hypnotic procedure evaluated by the clinician in the group "hypnosis"
time frame: one hour
description: The hypnotic procedure is assessed by three criteria:
receptivity of the patient (yes/no),
rapidity of focalization procedure (very fast, fast, medium, delayed, impossible to obtain),
quality of the hypnotic trance (very deep, deep, medium, superficial, not obtained).
measure: Characteristics of the hypnotic procedure evaluated by the patient in the group "hypnosis"
time frame: six hours
description: The hypnotic procedure is assessed by a question : "Did you visualize the memory we talked about before the session ? (yes, no )
measure: Characteristics of the preanesthetic management evaluated by the patient (all the patients)
time frame: Six hours
description: The preanesthetic management is assessed by one criteria:"How do you rate the quality of the preanesthetic period (from the entrance in the operating room to the induction of the general anesthesia ?" (excellent, good, average, not good)
arm group label: Control
arm group type: Active Comparator
description: Standard care without hypnosis session followed by closed-loop administration of propofol for anesthesia induction
arm group label: Hypnosis
arm group type: Experimental
description: Hypnosis session followed by closed-loop administration of propofol for anesthesia induction
intervention type: Procedure
intervention name: Control
description: Routine practice
arm group label: Control
intervention type: Procedure
intervention name: Hypnosis
description: Hypnosis session before induction of anesthesia
arm group label: Hypnosis
intervention type: Drug
intervention name: propofol
description: Closed-loop administration of propofol for anesthesia induction
arm group label: Control
arm group label: Hypnosis
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marc Fischler
role: Study Chair
affiliation: Hopital Foch
facility: 
country: France
citation: Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95. doi: 10.1097/00000542-200604000-00012.
PMID: 16571963
responsible party type: Sponsor
mesh term: Propofol