The 90% Effective Sedation Dose Of Midazolam

NCT03813043 | Unknown DMC

• 1 other identifier: ANS0307
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gastro-Esophageal Reflux Disease With Ulceration

Outcome Measures

Primary Outcomes (1)

• Defining the ED90% of Midazolam for sedation of EGD

  Calculating the effective Midazolam sedative dosage in 90% of patients undergoing EGD

  10 months

Study Arms (1)

Midazolam

OTHER

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

Drug: Midazolam injection

Interventions

Midazolam injection DRUG

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

Also known as: Dormicum

Midazolam

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA 1\&2

You may not qualify if:

• 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

Sponsors & Collaborators

• King Fahad Specialist Hospital Dammam: lead

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ahed zeidan, MD

  King Fahad Specialist Hospital Dammam

  STUDY DIRECTOR

Central Study Contacts

IRB IRB

CONTACT

+96613 844 2222; irb@kfsh.med.sa

Munir Bamadhaj, MD

CONTACT

+96613 844 2222; munir.bamdhaj@kfsh.med.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The result be found out at the end of the study
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

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

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 23, 2019
• Study Start: February 15, 2019
• Primary Completion: November 15, 2019
• Study Completion: December 15, 2019
• Last Updated: January 23, 2019

Record last verified: 2019-01