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The 90% Effective Sedation Dose Of Midazolam

Primary Purpose

Gastro-Esophageal Reflux Disease With Ulceration

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Midazolam injection
Sponsored by
King Fahad Specialist Hospital Dammam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastro-Esophageal Reflux Disease With Ulceration

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA 1&2

Exclusion Criteria:

  1. Patients with hypersensitivity to midazolam,
  2. Age less than 18,
  3. Obstructive sleep apnea
  4. known or suspected memory impairment,
  5. Patients with psychiatric disorders,
  6. visual or hearing impairment and pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Midazolam

    Arm Description

    Midazolam 2 mg as started dosage will be used for first patients and for the other patients will receive an predetermined dosage accordingly

    Outcomes

    Primary Outcome Measures

    Defining the ED90% of Midazolam for sedation of EGD
    Calculating the effective Midazolam sedative dosage in 90% of patients undergoing EGD

    Secondary Outcome Measures

    Full Information

    First Posted
    January 18, 2019
    Last Updated
    January 18, 2019
    Sponsor
    King Fahad Specialist Hospital Dammam
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03813043
    Brief Title
    The 90% Effective Sedation Dose Of Midazolam
    Official Title
    Determination Of The 90% Effective Sedation Dose Of Midazolam In Patients Undergoing Diagnostic Upper Gastric-Endoscopy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 15, 2019 (Anticipated)
    Primary Completion Date
    November 15, 2019 (Anticipated)
    Study Completion Date
    December 15, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    King Fahad Specialist Hospital Dammam

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastro-Esophageal Reflux Disease With Ulceration

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Searching the ED90% of Midazolam using Biased coins method in 40 patients undergoing EGD
    Masking
    None (Open Label)
    Masking Description
    The result be found out at the end of the study
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Midazolam
    Arm Type
    Other
    Arm 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(s)
    Midazolam injection
    Other Intervention Name(s)
    Dormicum
    Intervention Description
    Midazolam 2mg iv to be used as starting dose using Biased coins up and down method (BCM)
    Primary Outcome Measure Information:
    Title
    Defining the ED90% of Midazolam for sedation of EGD
    Description
    Calculating the effective Midazolam sedative dosage in 90% of patients undergoing EGD
    Time Frame
    10 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ASA 1&2 Exclusion Criteria: Patients with hypersensitivity to midazolam, Age less than 18, Obstructive sleep apnea known or suspected memory impairment, Patients with psychiatric disorders, visual or hearing impairment and pregnancy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    IRB IRB
    Phone
    +96613 844 2222
    Ext
    7093
    Email
    irb@kfsh.med.sa
    First Name & Middle Initial & Last Name or Official Title & Degree
    Munir Bamadhaj, MD
    Phone
    +96613 844 2222
    Ext
    3993
    Email
    munir.bamdhaj@kfsh.med.sa
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ahed zeidan, MD
    Organizational Affiliation
    King Fahad Specialist Hospital Dammam
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    Data will be collected inside the electronic system with limited access

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