Perioperative Analgesic and Anxiolytic Effect of Melatonin in Patients Undergoing Lumbar Laminectomy
试验速览
- 阶段
- 不适用
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Anxiety
研究概览
简要总结
Patients undergoing lumbar laminectomy surgery will receive either 5 or 10 mg melatonin or placebo once the evening before surgery and again 90 minutes before surgery. Pain and anxiety will be assessed over the 24 hour period following surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 to 65 years old
- •ASA status 1-3
- •having lumbar laminectomy 2 to 3 levels with or without fusion
排除标准
- •receiving emergent procedure
- •surgery for neoplastic spine lesion
- •allergy to melatonin or its non-medicinal ingredients
- •allergy or contraindication
- •BMI over 35 or or less than 20 kg/m2
- •pregnancy or breastfeeding
- •failure to provide informed consent
研究组 & 干预措施
Melatonin 5 mg
Patients will receive 5 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.
干预措施: 5 mg melatonin (Dietary Supplement)
Melatonin 10 mg
Patients will receive 10 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.
干预措施: 10 mg melatonin (Dietary Supplement)
Placebo
Patients will receive placebo once the evening before surgery and then again at 90 minutes before surgery.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Anxiety
时间窗: 24 hours
Anxiety will be assessed over a 24 hour following surgery using visual analogue scale
Pain
时间窗: 24 hours
Pain will be assessed over a 24 hour period following surgery using a visual analogue scale
次要结局
未报告次要终点