跳至主要内容
临床试验/EUCTR2014-003358-15-IE
EUCTR2014-003358-15-IE进行中(未招募)不适用

Intraoperative use of dexamethasone in day-case gynaecological surgery and its impact on sleep quality in the postoperative period.

James Martin Shannon, MB Bch NUI0 个研究点开始时间: 2015年4月10日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Female

入选标准

  • Subjects must be able and willing to give written informed consent and to comply with the requirements of the study protocol. Subjects must be female, aged 18 years or above. Subjects must be scheduled to undergo uterine dilation and curettage with or without hysteroscopy. Subjects must be judged to be in generally good health to undergo surgery based upon the results of the medical history, laboratory tests, physical examination, and +/- CXR and 12-lead electrocardiogram, performed during pre-assessment.
  • Subjects’ urine pregnancy test performed at pre-assessment must be negative. Subjects’ baseline PSQI score must be <6. Subjects must have clinically acceptable preoperative renal and hepatic function tests and a random blood glucose level between 4.4 - 7.8 mmol/l. Subjects must achieve satisfactory postoperative analgaesia with paracetamol and non- steroidal anti-inflammatory drugs (NSAIDs).
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 100
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Allergy/ sensitivity to dexamethasone. Patients younger than 18 years of age. Female subjects who are pregnant or breast-feeding at the time of surgery. Subjects unable to provide written informed consent. Subjects’ baseline PSQI score =6. Subjects who are chronic steroid users, as this may influence the result of the study. Subjects who have significant renal or hepatic impairment in preoperative laboratory tests that may influence the result of the study. Subjects who are known to suffer from diabetes mellitus or have an abnormal preoperative random blood glucose test, as it may put the subject at risk of hypoglycaemia. Subjects who require opioids for analgaesia in the postoperative period.

研究者

发起方
James Martin Shannon, MB Bch NUI

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