Study Comparing Atomizerd Midazolam & Fentanyl and Dexmedomidine for Procedural Sedation in Adult and Pediatric Patient (2 to 60 Years Old)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- depth of sedtion
研究概览
简要总结
To evaluate the depth of sedation, as well as onset, and recovery times, satisfaction of sedation , adverse events associated with Atomized Midazolam & Fentanyl and Dexmedetomidine during procedural sedation in a diverse population spanning from 2 to 60 years old at these three prominent Omani healthcare facilities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •inclusion criteria:
- •Patients aged 2 to 60 years.
- •Patients undergoing EM procedures requiring sedation.
- •Exclusion criteria:
- •Patients with contraindications to any of the sedation agents being studied.
- •Patients with a history of adverse reactions or allergies to the study medications.
- •Drug interactions: Patients taking certain medications that may interact adversely with the study medications.
- •Drug Abuser
- •Pregnancy and breastfeeding
- •Patients with significant cardiovascular or respiratory compromise.
- •Patients with nasal disorder (nasal trauma, epistaxis)
- •Patients unable to provide informed consent or those with cognitive impairment.
- •Patients who are < 2 year of age or > 60 year of age.
- •Patient underwent procedure sedation for imaging
排除标准
- 未提供
研究组 & 干预措施
midazolame $ fentanyl
use as compare between two group
干预措施: atomizer (Device)
midazolame $ fentanyl
use as compare between two group
干预措施: rescue medication (Drug)
midazolame $ fentanyl
use as compare between two group
干预措施: Midazolam (Drug)
midazolame $ fentanyl
use as compare between two group
干预措施: fentanyl (Drug)
dexetomidate
use as compare to other group
干预措施: atomizer (Device)
dexetomidate
use as compare to other group
干预措施: rescue medication (Drug)
dexetomidate
use as compare to other group
干预措施: Dexmedetomidine (Drug)
dexetomidate
use as compare to other group
干预措施: Placabo (Drug)
结局指标
主要结局
depth of sedtion
时间窗: 1 year
using MOAA/S score, Modified Observer's Assessment of Alertness/Sedation Scale , as 0 high score for deep sedation, 5 not in deep sedation
次要结局
未报告次要终点
研究者
Ghaliya Al Noofli
Principal Investigator
Oman Medical Speciality Board