The 90% Effective Sedation Dose Of Midazolam

K

King Fahad Specialist Hospital Dammam

Status

Unknown

Conditions

Gastro-Esophageal Reflux Disease With Ulceration

Treatments

Drug: Midazolam injection

Study type

Interventional

Funder types

Other

Identifiers

NCT03813043
ANS0307

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

ASA 1&2

Exclusion criteria

  • 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

Trial design

40 participants in 1 patient group

Midazolam
Other group
Description:
Midazolam 2 mg as started dosage will be used for first patients and for the other patients will receive an predetermined dosage accordingly
Treatment:
Drug: Midazolam injection

Trial contacts and locations

0

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Central trial contact

IRB IRB; Munir Bamadhaj, MD

Data sourced from clinicaltrials.gov

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