Emergence Agitation After Nasal Surgery: a Randomized Controlled Comparison Between Melatonin and Mirtazapine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Total number of patients with the Riker sedation-agitation score ≥5
研究概览
简要总结
Emergence agitation (EA) is common after nasal surgery under general anesthesia, which can lead to several problems, such as increased risk of injury to the patient or medical staff, pain, decreased patient satisfaction, hemorrhage, re-bleeding at the operation site and unplanned self-extubation.
Melatonin is an oral or sublingual medication, most commonly used for insomnia and improving sleep in different conditions for example shift-work disorder and for helping people to establish a day and night cycle especially blind children or adults.
Mirtazapine is an antidepressant used in medicine in a pill form, most commonly used for major depressive disorder and other mood disorders, relief of anxiety, panic disorders, insomnia, headache and migraine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients according to American Society of Anesthesiologists physical status classification (ASA) I or II.
- •Patients according to Mallampati classification I or II.
- •Patients accepting the study and consenting.
- •Undergoing general anesthesia for elective nasal surgery in which nasal packing on each side was used until 24 h after surgery.
- •Body mass index(BMI)<30
排除标准
- •Patient's refusal.
- •Known allergy to any of the study medications.
- •History of obstructive sleep apnea.
- •History of psychiatric illness or intake of antipsychotics.
- •History of liver impairment.
- •History of uncontrolled hypertension.
- •History of renal disease.
- •Body mass index (BMI) ≥30 kg/m
- •Contraceptive drugs.
研究组 & 干预措施
Mirtazapine group (Group I) (n=55)
干预措施: Mirtazapine (Drug)
Melatonin group (Group II) (n=55)
干预措施: Melatonin (Drug)
Placebo group (Group III) (n=55)
干预措施: Placebo (Drug)
结局指标
主要结局
Total number of patients with the Riker sedation-agitation score ≥5
时间窗: 24 hours postoperatively
Total number of patients with the Riker sedation-agitation score ≥5
次要结局
未报告次要终点
研究者
Dr.Ibrahim Mamdouh Esmat
Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.
Ain Shams University