Clinical trial NCT03813043: The 90% Effective Sedation Dose Of Midazolam
Official title: Determination Of The 90% Effective Sedation Dose Of Midazolam In Patients Undergoing Diagnostic Upper Gastric-Endoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastro-Esophageal Reflux Disease With Ulceration
Lead sponsor: King Fahad Specialist Hospital Dammam
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Searching the ED90% of Midazolam using Biased coins method in 40 patients undergoing EGD
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Defining the ED90% of Midazolam for sedation of EGD
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: King Fahad Specialist Hospital Dammam
name: Ahed zeidan, MD
role: STUDY_DIRECTOR
References: