The 90% Effective Sedation Dose Of Midazolam

Overview

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.

Full Title of Study: “Determination Of The 90% Effective Sedation Dose Of Midazolam In Patients Undergoing Diagnostic Upper Gastric-Endoscopy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 15, 2019

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.

Interventions

  • Drug: Midazolam injection
    • Midazolam 2mg iv to be used as starting dose using Biased coins up and down method (BCM)

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Defining the ED90% of Midazolam for sedation of EGD
    • Time Frame: 10 months
    • Calculating the effective Midazolam sedative dosage in 90% of patients undergoing EGD

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • King Fahad Specialist Hospital Dammam
  • Provider of Information About this Clinical Study
    • Principal Investigator: Munir Bamadhaj, Anesthesiologist – King Fahad Specialist Hospital Dammam
  • Overall Official(s)
    • Ahed zeidan, MD, Study Director, King Fahad Specialist Hospital Dammam
  • Overall Contact(s)
    • IRB IRB, +96613 844 2222, irb@kfsh.med.sa

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