<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/NCT02213302</url>
  </required_header>
  <id_info>
    <org_study_id>2014-000873-38</org_study_id>
    <secondary_id>PROM 2012_30</secondary_id>
    <nct_id>NCT02213302</nct_id>
  </id_info>
  <brief_title>Premedication by Midazolam for Emergency Surgery</brief_title>
  <official_title>Effects of Premedication by Midazolam on Preoperative Anxiety for Emergency Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Lille</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Preoperative anxiety is a subjective and painful experience and may have adverse&#xD;
      psychological consequences and complicate anesthetic management. The aim of the study is to&#xD;
      show the effect of premedication by midazolam on preoperative anxiety assessed by a visual&#xD;
      analog scale and by measuring salivary cortisol levels. This study was a monocentric,&#xD;
      prospective, blind randomized placebo controlled clinical study. Sixty patients, aged 18 to&#xD;
      79 years, to undergo elective surgery under general anesthesia with tracheal intubation must&#xD;
      be enrolled and randomized to receive midazolam (0.02mg/kg) or placebo. The primary outcome&#xD;
      is the reduction in anxiety assessed by a visual analog scale. The secondary outcomes are the&#xD;
      reduction in salivary cortisol levels, the overall level of anxiety and the evaluation of&#xD;
      respiratory and hemodynamic adverse effects of midazolam.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>visual analog scale of anxiety</measure>
    <time_frame>baseline, up to the end of support in recovery room</time_frame>
    <description>visual scale rated from 0 to 10 to describe the intensity of anxiety simple and reproducible measurement for a short period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>salivary cortisol level</measure>
    <time_frame>baseline and at the entrance in operating room</time_frame>
    <description>biologic measurement non-invasive, inexpensive and easy to perform. two determinations before and after premedication (at least 20 minutes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global anxiety</measure>
    <time_frame>baseline</time_frame>
    <description>rated from 4 to 20 for global anxiety and from 2 to 10 for information request anxiety is high above 10 for women and 12 for men</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's satisfaction</measure>
    <time_frame>at the end of the support in recovery room</time_frame>
    <description>rated from 1 for bad management to 5 for excellent management assessed at the output of the recovery room</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative consumption of hypnotics and opioids</measure>
    <time_frame>at anesthesia induction up to 10 minutes</time_frame>
    <description>Cumulative dose of hypnotics and opioids reduced to dose per kilogram</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comfort induction</measure>
    <time_frame>at anesthesia induction</time_frame>
    <description>rated from 1 for deep discomfort to 5 for good comfort</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intubation score</measure>
    <time_frame>after intubation</time_frame>
    <description>Rated from 1 bed conditions for intubation to 5 for excellent conditions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse midazolam effects</measure>
    <time_frame>baseline up to the end of support in recovery room</time_frame>
    <description>assessed by variations of arterial pressure, heart rate, respiratory rate, oxygen saturation and end tidal of carbon dioxide for hemodynamics and respiratory adverse effects assessed by Observer's assessment of alertness/sedation for deep of sedation rated from 1 sleeping patient to 5 for awake patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Output score of recovery room (Aldrete score)</measure>
    <time_frame>at the end of support in recovery room</time_frame>
    <description>rated from 0 to 10 essential for the output of recovery room</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>Isotonic serum</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Midazolam</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>midazolam intravenous administration 0.02mg/kg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo administration</intervention_name>
    <arm_group_label>Isotonic serum</arm_group_label>
    <arm_group_label>Midazolam</arm_group_label>
    <other_name>isotonic saline serum intravenous administration</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>midazolam intravenous administration</intervention_name>
    <arm_group_label>Isotonic serum</arm_group_label>
    <arm_group_label>Midazolam</arm_group_label>
    <other_name>hypnovel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  major patient undergoing elective surgery under general anesthesia with tracheal&#xD;
             intubation&#xD;
&#xD;
          -  Anesthesia state 1 and 2&#xD;
&#xD;
          -  preoperative fasting for 6 hours&#xD;
&#xD;
          -  information and signed consent&#xD;
&#xD;
          -  social security&#xD;
&#xD;
          -  non pregnant women&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  anesthesia state above 3&#xD;
&#xD;
          -  midazolam sensibility&#xD;
&#xD;
          -  pregnant or breastfeeding women&#xD;
&#xD;
          -  ICU patients&#xD;
&#xD;
          -  no consent&#xD;
&#xD;
          -  pediatric surgery&#xD;
&#xD;
          -  no social security&#xD;
&#xD;
          -  no tracheal intubation&#xD;
&#xD;
          -  required premedication in placebo group or midazolam sensibility in premedication&#xD;
             group&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elise Blondé-Zoonekynd, Physician</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emergency, University Hopital</name>
      <address>
        <city>Lille</city>
        <zip>59000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <results_reference>
    <citation>Sun GC, Hsu MC, Chia YY, Chen PY, Shaw FZ. Effects of age and gender on intravenous midazolam premedication: a randomized double-blind study. Br J Anaesth. 2008 Nov;101(5):632-9. doi: 10.1093/bja/aen251. Epub 2008 Sep 4.</citation>
    <PMID>18772216</PMID>
  </results_reference>
  <results_reference>
    <citation>Vogelsang J. The Visual Analog Scale: an accurate and sensitive method for self-reporting preoperative anxiety. J Post Anesth Nurs. 1988 Aug;3(4):235-9. No abstract available.</citation>
    <PMID>2457102</PMID>
  </results_reference>
  <results_reference>
    <citation>Bauer KP, Dom PM, Ramirez AM, O'Flaherty JE. Preoperative intravenous midazolam: benefits beyond anxiolysis. J Clin Anesth. 2004 May;16(3):177-83. doi: 10.1016/j.jclinane.2003.07.003.</citation>
    <PMID>15217656</PMID>
  </results_reference>
  <results_reference>
    <citation>Jerjes W, Jerjes WK, Swinson B, Kumar S, Leeson R, Wood PJ, Kattan M, Hopper C. Midazolam in the reduction of surgical stress: a randomized clinical trial. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 Nov;100(5):564-70. doi: 10.1016/j.tripleo.2005.02.087.</citation>
    <PMID>16243241</PMID>
  </results_reference>
  <results_reference>
    <citation>Wattier JM, Barreau O, Devos P, Prevost S, Vallet B, Lebuffe G. [Measure of preoperative anxiety and need for information with six issues]. Ann Fr Anesth Reanim. 2011 Jul-Aug;30(7-8):533-7. doi: 10.1016/j.annfar.2011.03.010. Epub 2011 May 23. French.</citation>
    <PMID>21602018</PMID>
  </results_reference>
  <results_reference>
    <citation>Moerman N, van Dam FS, Muller MJ, Oosting H. The Amsterdam Preoperative Anxiety and Information Scale (APAIS). Anesth Analg. 1996 Mar;82(3):445-51. doi: 10.1097/00000539-199603000-00002.</citation>
    <PMID>8623940</PMID>
  </results_reference>
  <results_reference>
    <citation>Reves JG, Fragen RJ, Vinik HR, Greenblatt DJ. Midazolam: pharmacology and uses. Anesthesiology. 1985 Mar;62(3):310-24.</citation>
    <PMID>3156545</PMID>
  </results_reference>
  <results_reference>
    <citation>Zalunardo MP, Ivleva-Sauerborn A, Seifert B, Spahn DR. [Quality of premedication and patient satisfaction after premedication with midazolam, clonidine or placebo : Randomized double-blind study with age-adjusted dosage]. Anaesthesist. 2010 May;59(5):410-8. doi: 10.1007/s00101-010-1695-9. German.</citation>
    <PMID>20224951</PMID>
  </results_reference>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <last_update_submitted>February 10, 2016</last_update_submitted>
  <last_update_submitted_qc>February 10, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 11, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>premedication</keyword>
  <keyword>preoperative anxiety</keyword>
  <keyword>salivary cortisol level</keyword>
  <keyword>anxiety visual analog scale</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Midazolam</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/NCT02213302
org study id: 2014-000873-38
secondary id: PROM 2012_30
nct id: NCT02213302
lead sponsor: 
has dmc: Yes
Preoperative anxiety is a subjective and painful experience and may have adverse
      psychological consequences and complicate anesthetic management. The aim of the study is to
      show the effect of premedication by midazolam on preoperative anxiety assessed by a visual
      analog scale and by measuring salivary cortisol levels. This study was a monocentric,
      prospective, blind randomized placebo controlled clinical study. Sixty patients, aged 18 to
      79 years, to undergo elective surgery under general anesthesia with tracheal intubation must
      be enrolled and randomized to receive midazolam (0.02mg/kg) or placebo. The primary outcome
      is the reduction in anxiety assessed by a visual analog scale. The secondary outcomes are the
      reduction in salivary cortisol levels, the overall level of anxiety and the evaluation of
      respiratory and hemodynamic adverse effects of midazolam.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: visual analog scale of anxiety
time frame: baseline, up to the end of support in recovery room
description: visual scale rated from 0 to 10 to describe the intensity of anxiety simple and reproducible measurement for a short period
measure: salivary cortisol level
time frame: baseline and at the entrance in operating room
description: biologic measurement non-invasive, inexpensive and easy to perform. two determinations before and after premedication (at least 20 minutes)
measure: Global anxiety
time frame: baseline
description: rated from 4 to 20 for global anxiety and from 2 to 10 for information request anxiety is high above 10 for women and 12 for men
measure: Patient's satisfaction
time frame: at the end of the support in recovery room
description: rated from 1 for bad management to 5 for excellent management assessed at the output of the recovery room
measure: Intraoperative consumption of hypnotics and opioids
time frame: at anesthesia induction up to 10 minutes
description: Cumulative dose of hypnotics and opioids reduced to dose per kilogram
measure: Comfort induction
time frame: at anesthesia induction
description: rated from 1 for deep discomfort to 5 for good comfort
measure: Intubation score
time frame: after intubation
description: Rated from 1 bed conditions for intubation to 5 for excellent conditions
measure: Adverse midazolam effects
time frame: baseline up to the end of support in recovery room
description: assessed by variations of arterial pressure, heart rate, respiratory rate, oxygen saturation and end tidal of carbon dioxide for hemodynamics and respiratory adverse effects assessed by Observer's assessment of alertness/sedation for deep of sedation rated from 1 sleeping patient to 5 for awake patient
measure: Output score of recovery room (Aldrete score)
time frame: at the end of support in recovery room
description: rated from 0 to 10 essential for the output of recovery room
arm group label: Isotonic serum
arm group type: Placebo Comparator
description: placebo administration
arm group label: Midazolam
arm group type: Active Comparator
description: midazolam intravenous administration 0.02mg/kg
intervention type: Drug
intervention name: placebo administration
arm group label: Isotonic serum
arm group label: Midazolam
other name: isotonic saline serum intravenous administration
intervention type: Drug
intervention name: midazolam intravenous administration
arm group label: Isotonic serum
arm group label: Midazolam
other name: hypnovel
criteria: 
gender: All
minimum age: 18 Years
maximum age: 79 Years
healthy volunteers: No
last name: Elise Blondé-Zoonekynd, Physician
role: Principal Investigator
affiliation: University Hospital, Lille
facility: 
country: France
citation: Sun GC, Hsu MC, Chia YY, Chen PY, Shaw FZ. Effects of age and gender on intravenous midazolam premedication: a randomized double-blind study. Br J Anaesth. 2008 Nov;101(5):632-9. doi: 10.1093/bja/aen251. Epub 2008 Sep 4.
PMID: 18772216
citation: Vogelsang J. The Visual Analog Scale: an accurate and sensitive method for self-reporting preoperative anxiety. J Post Anesth Nurs. 1988 Aug;3(4):235-9. No abstract available.
PMID: 2457102
citation: Bauer KP, Dom PM, Ramirez AM, O'Flaherty JE. Preoperative intravenous midazolam: benefits beyond anxiolysis. J Clin Anesth. 2004 May;16(3):177-83. doi: 10.1016/j.jclinane.2003.07.003.
PMID: 15217656
citation: Jerjes W, Jerjes WK, Swinson B, Kumar S, Leeson R, Wood PJ, Kattan M, Hopper C. Midazolam in the reduction of surgical stress: a randomized clinical trial. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 Nov;100(5):564-70. doi: 10.1016/j.tripleo.2005.02.087.
PMID: 16243241
citation: Wattier JM, Barreau O, Devos P, Prevost S, Vallet B, Lebuffe G. [Measure of preoperative anxiety and need for information with six issues]. Ann Fr Anesth Reanim. 2011 Jul-Aug;30(7-8):533-7. doi: 10.1016/j.annfar.2011.03.010. Epub 2011 May 23. French.
PMID: 21602018
citation: Moerman N, van Dam FS, Muller MJ, Oosting H. The Amsterdam Preoperative Anxiety and Information Scale (APAIS). Anesth Analg. 1996 Mar;82(3):445-51. doi: 10.1097/00000539-199603000-00002.
PMID: 8623940
citation: Reves JG, Fragen RJ, Vinik HR, Greenblatt DJ. Midazolam: pharmacology and uses. Anesthesiology. 1985 Mar;62(3):310-24.
PMID: 3156545
citation: Zalunardo MP, Ivleva-Sauerborn A, Seifert B, Spahn DR. [Quality of premedication and patient satisfaction after premedication with midazolam, clonidine or placebo : Randomized double-blind study with age-adjusted dosage]. Anaesthesist. 2010 May;59(5):410-8. doi: 10.1007/s00101-010-1695-9. German.
PMID: 20224951
responsible party type: Sponsor
mesh term: Emergencies
mesh term: Anxiety Disorders
mesh term: Midazolam