ACTRN12620000031965进行中(未招募)3 期
Melatonin to Improve Sleep in Patients Undergoing Major Abdominal Surgery:A Double-blind, Randomised Placebo-controlled Trial
Hunter New England Local Health District.0 个研究点目标入组 152 人开始时间: 2020年1月20日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 152
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •All English-speaking patients 18 years and over undergoing elective/semi-elective major abdominal surgery with an anticipated length of stay greater than 48 hours.
排除标准
- •Patients from the above group will be excluded if they:
- •Are unable to give written informed consent to take part in the study,
- •Patients who require the use of a trained healthcare interpreter to be able to understand study information.
- •Lack decision-making capacity,
- •Expected stay less than 48 hours,
- •Concurrent use of benzodiazepine, non-benzodiazepine (Z-drugs) or melatonin,
- •Alcohol consumption > 13 units/week for women and >20 units/week for men.
- •Currently taking melatonin
- •Drug interaction with melatonin.
- •Allergy to melatonin or its excipients (may contain lactose)
- •Decreased renal function as defined by an eGFR of <30 mL/min/1.73m2
- •Decreased liver function defined as an AST > 500 U/L or ALT >500 U/L
- •Pregnant or breastfeeding females
- •Enrolment in other clinical trials involving an investigational agent
- •Taking quinolones, carbamazepine and rifampicin, fluvoxamine, 5- or 8- methoxypsoralen, cimetidine, oestrogens.
研究者
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