A Randomized, Double-blind, Placebo-controlled Trial to Assess the Safety and Efficacy of the Perioperative Administration of Pregabalin in Reducing the Incidence of Postoperative Delirium and Improving Acute Postoperative Pain Management
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Delirium (patient is either CAM-ICU positive or positive for delirium by chart review)
研究概览
简要总结
The purpose of this study is to determine whether administration of pregabalin by mouth immediately preoperatively and three times daily for 3 days after surgery reduces the incidence of delirium postoperatively and improves overall pain control.
详细描述
Delirium is a common postoperative complication occurring in up to 73% of patients sometime during their hospital stay. Elderly patients undergoing major surgical procedures are at highest risk. While many risk factors for delirium are known, the specific pathophysiology of postoperative delirium remains unclear and is likely multifactorial. The most common inciting agents and events include metabolic causes, medications, blood loss, hypoxemia and pain. Pain and its management are intimately related to the likelihood of developing postoperative delirium. As a class, gabapentinoids, such as pregabalin, have proven to reduce postoperative pain and narcotic consumption and therefore may have a role to play in the prevention of postoperative delirium.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 60 years and older
- •booked for major orthopaedic or vascular procedure
- •expected length of stay > 2 days
排除标准
- •open AAA repair
- •allergy/sensitivity to pregabalin or gabapentin
- •use of pregabalin or gabapentin in previous 14 days
- •severe liver disease
- •severe renal dysfunction defined as either having creatinine clearance < 30 ml/min or being dialysis-dependent
- •seizure disorder
- •MMSE < 24/30
- •inability to speak English or French
研究组 & 干预措施
Sugar pill
Single dose given 30-60 minutes preoperatively, then given every 8 hours for 3 days postoperatively
干预措施: Sugar pill (Other)
Pregabalin
Single dose of 75 mg given 30-60 minutes preoperatively, then 50 mg every 8 hours for 3 days postoperatively if creatinine clearance > 60 ml/min OR 25 mg every 8 hours for 3 days postoperatively if creatinine clearance 30-60 ml/min
干预措施: Pregabalin (Drug)
结局指标
主要结局
Delirium (patient is either CAM-ICU positive or positive for delirium by chart review)
时间窗: postoperative day 1, 2, 3
次要结局
- Interference with daily activities using BPI(postoperative day 3)
- Pain at rest using NRS(postoperative days 1, 2, 3)
- Pain with movement of the operative site using NRS(postoperative days 1, 2, 3)
- Narcotic analgesic requirements(postoperative days 0, 1, 2, 3)
- Sedation using RSS(postoperative days 1, 2, 3)
- Narcotic-related adverse effects using ORSDS(postoperative days 1, 2, 3)
- Recovery using the QoR(postoperative day 3)
- Length of stay(Discharge day)
- Medical Outcome Study (MOS) sleep score(Postoperative day 3)
研究者
Dr. A. Chaput
Clinician Investigator
Ottawa Hospital Research Institute