跳至主要内容
临床试验/ACTRN12620000031965
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

发起方
Hunter New England Local Health District.

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