NCT01126294Unknown不适用
Perioperative Analgesic and Anxiolytic Effect of Melatonin in Patients Undergoing Lumbar Laminectomy
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Pain
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
结局指标
主要结局
Pain
时间窗: 24 hours
Pain will be assessed over a 24 hour period following surgery using a visual analogue scale
Anxiety
时间窗: 24 hours
Anxiety will be assessed over a 24 hour following surgery using visual analogue scale
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
招募中
不适用
Melatonin and Its Effect on the Perioperative Opioid Needs in Pediatric Patients Undergoing Laparoscopic Surgery.Postoperative PainNCT05728892Ain Shams University72
尚未招募
不适用
Can music and a drug (melatonin)help in decreasing nervousness before operation?CTRI/2018/02/011895Department of Anaesthesia and Intensive Care
已完成
不适用
Evaluation of melatonin's effect on pain and blood loss after cesarean sectiopostoperative hemorrhage.Haemorrhage and haematoma complicating a procedure, not elsewhere classifiedIRCT2012120411665N1Qazvin University of Medical Sciences120
尚未招募
不适用
The effects of melatonin versus placebo on post-operative delirium (POD) in hip fracture patients – a randomized double-blind trialMelatonin, delirium, prevention, hipfracturesMelatonine, delirium, preventie, heupfracturenNL-OMON23033S.E. de Rooij / Academic Medical Centre AmsterdamAcademic Medical CenterMeibergdreef 91105 AZ AmsterdamThe NetherlandsTel. (31)205665991Fax (31)205669325175
已完成
不适用
To study effectiveness of Drug Melatonin for pain after surgery, in patients of cancer of head and neck region.CTRI/2022/03/040841All India Institute of Medical Sciences Rishikesh60