<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/NCT03813043</url>
  </required_header>
  <id_info>
    <org_study_id>ANS0307</org_study_id>
    <nct_id>NCT03813043</nct_id>
  </id_info>
  <brief_title>The 90% Effective Sedation Dose Of Midazolam</brief_title>
  <official_title>Determination Of The 90% Effective Sedation Dose Of Midazolam In Patients Undergoing Diagnostic Upper Gastric-Endoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Fahad Specialist Hospital Dammam</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Fahad Specialist Hospital Dammam</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>
      There are no clear conclusive clinical reports defining the adequate effective dose of&#xD;
      midazolam in patients undergoing day-case esophageal-gastro-duodenoscopy (EGD). Defining such&#xD;
      dosage will facilitate practitioners who are not anesthesia professionals to administer&#xD;
      sedative drugs to establish a satisfactory level of moderate sedation. Our first aim is to&#xD;
      determine the effective dose for 90% of patients (ED 90) of midazolam undergoing day-case&#xD;
      EGD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Midazolam is widely used in conscious sedation during esophageal-gastro-duodenoscopy (EGD) to&#xD;
      increase patient's tolerance and cooperation. Its short duration, cardiorespiratory&#xD;
      stability, anxiolytic and amnestic properties makes it the drug of choice for moderate&#xD;
      sedation in day case short procedure 1. Therefore, moderate sedation during digestive&#xD;
      endoscopy can be administered by endoscopist in safe monitored area while a qualified nurse&#xD;
      monitors the level of consciousness and vital sings. The endoscopist's privileges to&#xD;
      administer deeper alternative drug, i.e. propofol, might not be provided easily in many&#xD;
      centers especially outside the hospital due to certain limitations. However, the patient's&#xD;
      and endoscopist's satisfaction might not be achieved easily with the administration of&#xD;
      midazolam for moderate sedation. Inappropriate dose will fail to produce amnesia or may cause&#xD;
      respiratory side effect and delayed recovery and discharge. Therefore, there are no clear&#xD;
      conclusive clinical reports defining the adequate effective dose of midazolam in patients&#xD;
      undergoing day case EGD. This is obvious from different dosage used in various studies. In&#xD;
      addition, midazolam dosage in adult is rarely based on the body weight during our daily&#xD;
      clinical practice. Defining such dosage will facilitate practitioners who are not anesthesia&#xD;
      professionals to administer sedative drugs to establish satisfactory level of moderate&#xD;
      sedation. Our first aim is to determine the effective dose for 90% of patients (ED 90) of&#xD;
      midazolam undergoing day case EGD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 15, 2019</start_date>
  <completion_date type="Anticipated">December 15, 2019</completion_date>
  <primary_completion_date type="Anticipated">November 15, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Searching the ED90% of Midazolam using Biased coins method in 40 patients undergoing EGD</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>The result be found out at the end of the study</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Defining the ED90% of Midazolam for sedation of EGD</measure>
    <time_frame>10 months</time_frame>
    <description>Calculating the effective Midazolam sedative dosage in 90% of patients undergoing EGD</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Gastro-Esophageal Reflux Disease With Ulceration</condition>
  <arm_group>
    <arm_group_label>Midazolam</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Midazolam 2 mg as started dosage will be used for first patients and for the other patients will receive an predetermined dosage accordingly</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Midazolam injection</intervention_name>
    <description>Midazolam 2mg iv to be used as starting dose using Biased coins up and down method (BCM)</description>
    <arm_group_label>Midazolam</arm_group_label>
    <other_name>Dormicum</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA 1&amp;2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with hypersensitivity to midazolam,&#xD;
&#xD;
          2. Age less than 18,&#xD;
&#xD;
          3. Obstructive sleep apnea&#xD;
&#xD;
          4. known or suspected memory impairment,&#xD;
&#xD;
          5. Patients with psychiatric disorders,&#xD;
&#xD;
          6. visual or hearing impairment and pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahed zeidan, MD</last_name>
    <role>Study Director</role>
    <affiliation>King Fahad Specialist Hospital Dammam</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>IRB IRB</last_name>
    <phone>+96613 844 2222</phone>
    <phone_ext>7093</phone_ext>
    <email>irb@kfsh.med.sa</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Munir Bamadhaj, MD</last_name>
    <phone>+96613 844 2222</phone>
    <phone_ext>3993</phone_ext>
    <email>munir.bamdhaj@kfsh.med.sa</email>
  </overall_contact_backup>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>January 18, 2019</last_update_submitted>
  <last_update_submitted_qc>January 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>King Fahad Specialist Hospital Dammam</investigator_affiliation>
    <investigator_full_name>Munir Bamadhaj</investigator_full_name>
    <investigator_title>Anesthesiologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroesophageal Reflux</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Midazolam</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Data will be collected inside the electronic system with limited access</ipd_description>
  </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/NCT03813043
org study id: ANS0307
nct id: NCT03813043
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
There are no clear conclusive clinical reports defining the adequate effective dose of
      midazolam in patients undergoing day-case esophageal-gastro-duodenoscopy (EGD). Defining such
      dosage will facilitate practitioners who are not anesthesia professionals to administer
      sedative drugs to establish a satisfactory level of moderate sedation. Our first aim is to
      determine the effective dose for 90% of patients (ED 90) of midazolam undergoing day-case
      EGD.
Midazolam is widely used in conscious sedation during esophageal-gastro-duodenoscopy (EGD) to
      increase patient's tolerance and cooperation. Its short duration, cardiorespiratory
      stability, anxiolytic and amnestic properties makes it the drug of choice for moderate
      sedation in day case short procedure 1. Therefore, moderate sedation during digestive
      endoscopy can be administered by endoscopist in safe monitored area while a qualified nurse
      monitors the level of consciousness and vital sings. The endoscopist's privileges to
      administer deeper alternative drug, i.e. propofol, might not be provided easily in many
      centers especially outside the hospital due to certain limitations. However, the patient's
      and endoscopist's satisfaction might not be achieved easily with the administration of
      midazolam for moderate sedation. Inappropriate dose will fail to produce amnesia or may cause
      respiratory side effect and delayed recovery and discharge. Therefore, there are no clear
      conclusive clinical reports defining the adequate effective dose of midazolam in patients
      undergoing day case EGD. This is obvious from different dosage used in various studies. In
      addition, midazolam dosage in adult is rarely based on the body weight during our daily
      clinical practice. Defining such dosage will facilitate practitioners who are not anesthesia
      professionals to administer sedative drugs to establish satisfactory level of moderate
      sedation. Our first aim is to determine the effective dose for 90% of patients (ED 90) of
      midazolam undergoing day case EGD.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Searching the ED90% of Midazolam using Biased coins method in 40 patients undergoing EGD
primary purpose: Treatment
masking: None (Open Label)
masking description: The result be found out at the end of the study
measure: Defining the ED90% of Midazolam for sedation of EGD
time frame: 10 months
description: Calculating the effective Midazolam sedative dosage in 90% of patients undergoing EGD
arm group label: Midazolam
arm group type: Other
description: Midazolam 2 mg as started dosage will be used for first patients and for the other patients will receive an predetermined dosage accordingly
intervention type: Drug
intervention name: Midazolam injection
description: Midazolam 2mg iv to be used as starting dose using Biased coins up and down method (BCM)
arm group label: Midazolam
other name: Dormicum
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Ahed zeidan, MD
role: Study Director
affiliation: King Fahad Specialist Hospital Dammam
last name: IRB IRB
phone: +96613 844 2222
phone ext: 7093
email: irb@kfsh.med.sa
last name: Munir Bamadhaj, MD
phone: +96613 844 2222
phone ext: 3993
email: munir.bamdhaj@kfsh.med.sa
responsible party type: Principal Investigator
investigator affiliation: King Fahad Specialist Hospital Dammam
investigator full name: Munir Bamadhaj
investigator title: Anesthesiologist
mesh term: Gastroesophageal Reflux
mesh term: Midazolam
sharing ipd: Undecided
ipd description: Data will be collected inside the electronic system with limited access