The 90% Effective Sedation Dose Of Midazolam

Not Applicable

• Conditions: Gastro-Esophageal Reflux Disease With Ulceration
• Interventions: Drug: Midazolam injection

• Registration Number: NCT03813043
• Lead Sponsor: King Fahad Specialist Hospital Dammam

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.

Study Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-01-18
• Study First Submitted QC: 2019-01-18
• Last Update Submitted: 2019-01-18
• Study First Posted: 2019-01-23
• Last Update Posted: 2019-01-23
• Study Start: 2019-02-15
• Primary Completion: 2019-11-15
• Study Completion: 2019-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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