Use of Melatonin for Prevention of POCD After TURP Surgery Under Spinal Anesthesia for Elderly Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- early postoperative cognitive dysfunction
研究概览
简要总结
This study aims to evaluate the possible effect of melatonin on prevention of cognitive dysfunction in the postoperative period of elderly patients undergoing transurethral resection of the prostate (TURP) under spinal anesthesia
详细描述
TURP is the most common surgical procedure performed on male patients over 60 years of age to treat benign prostatic hyperplasia.
One of the concerns, since it compromises the quality of life, is postoperative cognitive dysfunction. It can be due to TURP Syndrome or to other causes, like changing the routine and circadian rhythm for patients with more susceptibility.
The investigators postulate that melatonin premedication and use during the perioperative period could avoid cognitive impairment in patients undergoing TURP surgery that didn't develop major complications, like TURP Syndrome.
Since anesthestic technic could also influence the outcome of POCD, only patients undergoing spinal anesthesia were included in the study,
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
triple masking
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •patients over 60 years who underwent elective surgery for transurethral prostate ressection under spinal anesthesia.
- •MME > 18 (for those who had less than 4 years of formal education ) or MME > 23 (for those with 4 or more years of formal education)
排除标准
- •MME < 18 (for those who had less than 4 years of formal eduaction) or 23 (for those with 4 years or more of formal eduacation); History of cancer, brain disease, seizure, Parkinson, dementia, hallucination or any disorder that affects cognition before the surgery.
- •Lack of proficiency in portuguese mild or severe hearing loss or blindness.
研究组 & 干预措施
melatonin group
for the melatonin group, 10 mg of melatonin will be taken per os in the evening before the surgery and in the immediate postoperative night and the first and second postoperative days.
干预措施: melatonin (Dietary Supplement)
placebo group
For the placebo group, placebo will be administered per os in the evening before the surgery and in the immediate postoperative night and the first and second postoperative days.
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
early postoperative cognitive dysfunction
时间窗: 30 days
a full battery of neuropsychological tests including FOME (Fuld Object memory evaluation test), Stroops colours world test, Trail making test and Wais-III were applied in the preoperative day and compared to the 30-postoperative day evaluation. A z score decline higher than 0,5 in two different domains defines an early postoperative cognitive dysfunction
次要结局
- late postoperative cognitive dysfunction(180 days)
研究者
Maria José Carvalho Carmona
professor
University of Sao Paulo