The 90% Effective Sedation Dose Of Midazolam

Gastro-Esophageal Reflux Disease With Ulceration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03813043
• Other study ID #: ANS0307
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 15, 2019
• Est. completion date: December 15, 2019

Study information

• Verified date: January 2019
• Source: King Fahad Specialist Hospital Dammam
• Contact: IRB IRB
• Phone: +96613 844 2222
• Email: irb[@]kfsh.med.sa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 15, 2019
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastro-Esophageal Reflux Disease With Ulceration
• Gastroesophageal Reflux

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King Fahad Specialist Hospital Dammam

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Defining the ED90% of Midazolam for sedation of EGD	Calculating the effective Midazolam sedative dosage in 90% of patients undergoing EGD	10 months