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The 90% Effective Sedation Dose Of Midazolam

Determination Of The 90% Effective Sedation Dose Of Midazolam In Patients Undergoing Diagnostic Upper Gastric-Endoscopy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03813043
Enrollment
40
Registered
2019-01-23
Start date
2019-02-15
Completion date
2019-12-15
Last updated
2019-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastro-Esophageal Reflux Disease With Ulceration

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.

Interventions

DRUGMidazolam injection

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

Sponsors

King Fahad Specialist Hospital Dammam
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Masking description

The result be found out at the end of the study

Intervention model description

Searching the ED90% of Midazolam using Biased coins method in 40 patients undergoing EGD

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Defining the ED90% of Midazolam for sedation of EGD10 monthsCalculating the effective Midazolam sedative dosage in 90% of patients undergoing EGD

Contacts

Primary ContactIRB IRB
irb@kfsh.med.sa+96613 844 2222
Backup ContactMunir Bamadhaj, MD
munir.bamdhaj@kfsh.med.sa+96613 844 2222

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026