The Use of Sublingual Melatonin Premedication in Geriatric Cataract Surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- perioperative anxiety
研究概览
简要总结
Cataract surgery is routinely performed with anesthesia care, whereas anesthesia care for other elective, low-risk, outpatient procedures is applied more selectively. We hypothesize that sublingual melatonin will provide superior anxiolysis and sedation while maintaining a high safety profile and minimizing hemodynamic disturbances.
详细描述
Prevalence of anesthesia care during cataract surgery compared with other low-risk procedures; association of anesthesia care with patient, clinician, and health system characteristics; and proportion of patients experiencing a significant anxiety and hemodynamic instability during cataract surgery.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Age ≥ 60 years
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Scheduled for unilateral cataract surgery under local anesthesia
- •Ability to understand and complete study-related questionnaires
排除标准
- •• Known allergy or hypersensitivity to melatonin
- •Chronic use of sedatives, hypnotics, or anxiolytics
- •History of sleep disorders or psychiatric illness
- •Visual or hearing impairment that would hinder communication
- •Emergency surgery or anticipated intraoperative complications
研究组 & 干预措施
Melatonin Group
a 6 mg sublingual tablet of melatonin will be administered for all patients at 60 minutes before surgery.
干预措施: Sublingual Melatonin (Drug)
Placebo Group
the participants will be received a visually identical tablet containing inert ingredients at 60 minutes before surgery.
干预措施: Sublingual Placebo (Drug)
结局指标
主要结局
perioperative anxiety
时间窗: at 30 and 60 minutes before procedure, with application of local anesthesia, 15 and 30 minutes after anesthesia.
It will be assessed using the Visual Analog Scale (VAS) for anxiety (0-10 cm) upon arrival to the operating room.
次要结局
未报告次要终点
研究者
Neveen Abd El Maksoad Kohaf
Lecturer of clinical pharmacy
Al-Azhar University