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
About this trial
This is an interventional treatment trial for Gastro-Esophageal Reflux Disease With Ulceration
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
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
NCT ID
NCT03813043
First Posted
January 18, 2019
Last Updated
January 18, 2019
Sponsor
King Fahad Specialist Hospital Dammam
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
Learn more about this trial
The 90% Effective Sedation Dose Of Midazolam
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