The 90% Effective Sedation Dose Of Midazolam

NCT ID: NCT03813043

Last Updated: 2019-01-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-15
• Study Completion Date: 2019-12-15

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.

Conditions

Gastro-Esophageal Reflux Disease With Ulceration

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Midazolam

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

Group Type: OTHER

Midazolam injection

Intervention Type: DRUG

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

Interventions

Midazolam injection

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

Intervention Type: DRUG

Other Intervention Names

Dormicum

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Fahad Specialist Hospital Dammam

OTHER

Sponsor Role: lead

Responsible Party

Munir Bamadhaj

Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahed zeidan, MD

Role: STUDY_DIRECTOR

King Fahad Specialist Hospital Dammam

Central Contacts

IRB IRB

Role: CONTACT

irb@kfsh.med.sa

+96613 844 2222 ext. 7093

Munir Bamadhaj, MD

Role: CONTACT

munir.bamdhaj@kfsh.med.sa

+96613 844 2222 ext. 3993

Other Identifiers

ANS0307

Identifier Type: -

Identifier Source: org_study_id