A Randomized Double Blind Placebo Controlled Trial of Ramelteon in the Prevention of Post-operative Delirium in Older Patients Undergoing Orthopedic Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Number of Participants With Delirium During Two Days Following Surgery
研究概览
简要总结
This trial focuses on a Phase II randomized masked clinical trial testing the effectiveness and safety of peri-operative administration of ramelteon, a melatonin agonist in the prevention of postoperative delirium.
详细描述
This trial will randomize older aged patients undergoing general or regional anesthesia for orthopedic surgical procedures to three perioperative doses of a melatonin agonist, ramelteon, and placebo in a masked double blind fashion. The primary outcomes are 1) the incidence of post-operative delirium in the recovery period in the Postoperative Anesthesia Care Unit and on post-operative days 1 and 2 following surgery, and 2) the safety of ramelteon as documented by the presence of adverse events in the follow-up period.
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)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Delirium diagnosis on the Confusion Assessment Method instrument at baseline
- •Is unable to give informed consent due to cognitive impairment and a suitable legally authorized representative (LAR) cannot be identified
- •Declines participation
- •Current medications that include:
- •fluvoxamine
- •ketoconazole
- •fluconazole
- •History of ramelteon or riboflavin intolerance
- •Heavy daily alcohol intake by medical record or history
- •Current moderate to severe liver failure (as defined by Charlson criteria
- •Evidence of Systemic Inflammatory Response Syndrome (SIRS) as measured by > 2 criteria8)
- •Presence of a condition that in the opinion of the PI compromises patient safety or data quality if enrolled in the study.
研究组 & 干预措施
Treatment
Ramelteon 8 mg oral dose Riboflavin 100 mg (preoperative first dose only)
干预措施: Ramelteon (Drug)
Treatment
Ramelteon 8 mg oral dose Riboflavin 100 mg (preoperative first dose only)
干预措施: Microcrystalline Cellulose (Drug)
Placebo
Capsule Shells filled with microcrystalline cellulose Riboflavin 100 mg (preoperative first dose only - if received as an outpatient)
干预措施: Riboflavin 100 mg (Drug)
Treatment
Ramelteon 8 mg oral dose Riboflavin 100 mg (preoperative first dose only)
干预措施: Riboflavin 100 mg (Drug)
Placebo
Capsule Shells filled with microcrystalline cellulose Riboflavin 100 mg (preoperative first dose only - if received as an outpatient)
干预措施: Microcrystalline Cellulose (Drug)
结局指标
主要结局
Number of Participants With Delirium During Two Days Following Surgery
时间窗: Up to Post Operative Day 2
Delirium DSM 5 based criteria informed by standardized history gathering, examination, cognitive evaluation using cognitive tests, informant interview, and medical record review) measured during Post-operative Day 1 and/or Day 2
Number of Participants With Delirium in the Post Anesthesia Care Unit (PACU)
时间窗: Post Operative Day 0: Post Anesthesia Care Unit Following Recovery from Anesthesia
Delirium (DSM 5 based criteria informed by standardized history gathering, examination, cognitive evaluation using cognitive tests, informant interview, and medical record review) measured once recovered from anesthesia.
次要结局
- Delirium Rating Scale - Revised- 98 (DRS-R98) in Delirious Patients(Postoperative Day 1 and Day 2)