Comparison of Effect of Dexmedetomidine and Midazolam on Emergence Agitation in Patients Undergoing Functional Endoscopic Sinus Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Effectiveness in emergence agitation
研究概览
简要总结
Since the frequency of emergence agitation (EA) is relatively high in children while undergoing nasal surgery, and there is not much data available in Pakistan regarding EA in adults undergoing functional endoscopic sinus surgery (FESS). Hence there is a need to conduct this study in the local population to see the effect of dexmedetomidine and midazolam on EA. Therefore, the current study was initiated, aiming to compare the effect of dexmedetomidine and midazolam on EA in patients undergoing FESS.
详细描述
There is not much local data present on the topic of EA. As the frequency of EA is relatively high, it can lead to any unwanted event, which can lead to other complications in the patients undergoing nasal surgery. Although in some studies dexmedetomidine has been found to significantly reduce the frequency of EA and severity, provide better sedation, and lower the need for postoperative rescue analgesia in patients undergoing FESS, few others have claimed comparable results for midazolam as well. The findings of this study would not only add to the local data but also be helpful in determining a better option in reducing the frequency of this phenomenon in patients undergoing FESS under general anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any gender
- •Aged 16-60 years
- •Undergoing elective FESS under general anesthesia
排除标准
- •Patients with the presence of infection at the site of the blockage
- •Epilepsy, myasthenia gravis, or polio (as per history and clinical record)
- •Systemic illness (such as cardiac, hepatic, endocrinal or neurological)
- •Substance induced disorder
- •Psychiatric disorders
- •Taking medications, such as alpha 2 agonists, beta blockers' or tricyclic anti-depressants
- •Allergies to the medications used
研究组 & 干预措施
Group-D
Patients were given a dexmedetomidine injection with a loading dose of 1 µg/kg in 10 minutes prior to the procedure.
干预措施: Dexmedetomidine (Drug)
Group-M
Patients received a midazolam injection with a loading dose of 0.02 mg/kg in 10 min prior the procedure.
干预措施: Midazolam (Drug)
结局指标
主要结局
Effectiveness in emergence agitation
时间窗: 90 minutes
The effectiveness of the treatment was assessed through Ricker's sedation and agitation score, with a score of 4 as efficacy 'yes'.
次要结局
未报告次要终点
研究者
Muhammad Aamir Latif
Research Consultant
RESnTEC, Institute of Research