跳至主要内容
临床试验/NCT03813043
NCT03813043Unknown不适用

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

King Fahad Specialist Hospital Dammam0 个研究点目标入组 40 人开始时间: 2019年2月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
40
主要终点
Defining the ED90% of Midazolam for sedation of EGD

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

The result be found out at the end of the study

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 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

研究组 & 干预措施

Midazolam

Other

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

干预措施: Midazolam injection (Drug)

结局指标

主要结局

Defining the ED90% of Midazolam for sedation of EGD

时间窗: 10 months

Calculating the effective Midazolam sedative dosage in 90% of patients undergoing EGD

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Munir Bamadhaj

Anesthesiologist

King Fahad Specialist Hospital Dammam

相似试验

The 90% Effective Sedation Dose Of Midazolam | 临床试验