A Phase III,Randomized, Double-Blind, Placebo-Controlled, Two-Arm Parallel, Multicenter Study Evaluating the Efficacy and Safety of Dexmedetomidine in the Prevention of Postoperative Delirium in Subjects Undergoing Surgery for Fractured Hip With General Anesthesia
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 52
- 试验地点
- 30
- 主要终点
- Percentage of subjects who experienced any postoperative delirium up to 3 days after the end of study drug infusion
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of perioperative use of dexmedetomidine in the prevention of postoperative delirium in subjects undergoing surgery for fractured hip with general anesthesia.
详细描述
Postoperative delirium is an acute decline in cognition and attention which is usually transient but when delirium persists it can impact cognitive function, morbidity and morality. There are no drugs that are currently approved to prevent the onset of delirium but dexmedetomidine has the potential to meet this unmet medical need. Hip fractures, unfortunately are frequent occurrences in the elderly population and the elderly are more prone to developing delirium after surgery.
Dexmedetomidine is currently approved for use for 24 hours in patients on ventilators in the ICU. Study participation will last from within 72 hours of surgery to 3 days after surgery, continue throughout surgery and up to 2 hours after surgery. Delirium will be assessed prior to surgery and for 72 hours after surgery. This assessment will consist of questions to determine memory and thought process. At discharge patient's resource utilization will be evaluated and thirty days after surgery questions will be asked regarding quality of life.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (≥18 years old) male or female who will undergo surgery for fractured hip with general anesthesia within 72 hours of admission to hospital.
- •If female, subject is non-lactating and is either:
- •Not of childbearing potential, defined as post-menopausal for at least 1 year or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy or hysterectomy.
- •Of childbearing potential but is not pregnant at time of baseline and is practicing one of the following methods of birth control: oral or parenteral contraceptives, double-barrier method, vasectomized partner, or abstinence from sexual intercourse.
- •Subject is American Society of Anesthesiologists Physical Status I, II, III, or IV.
- •Subject (or subject's legally authorized representative) has voluntarily signed and dated the informed consent document approved by the Institutional Review Board (IRB).
排除标准
- •Cognitive function level by Mini Mental State Exam (MMSE) of ≤
- •Subject has a positive CAM-ICU result for delirium at Screening or Baseline.
- •Subject requires chronic antipsychotic therapy.
- •Subject is anticipated to require additional surgical procedures during the 72 hour Screening Period and the 3 days Follow-up Period.
- •Subject is anticipated to require repair of pelvic fractures (eg,acetabulum).
- •Subject has participated in a trial with any experimental drug or experimental implantable device within 30 days prior to the study drug administration, or has ever been enrolled in this study.
- •Subject known to be in liver failure.
- •Subject has an anticipated potential for increased intracranial pressure or an uncontrolled seizure disorder or known psychiatric illness that could confound a normal response during study assessment.
- •Subject has received treatment with a α2-agonist or antagonist (within 14 days of study entry).
- •Subject for whom opiates, benzodiazepines, DEX or other α2-agonists are contraindicated.
- •Subject has, per the investigator's judgment, a known or suspected physical or psychological dependence on an abused drug, other than alcohol.
- •Subject has acute unstable angina, acute myocardial infarction, HR <50 bpm, SBP <90 mmHg, or third degree heart block unless the subject has a pacemaker.
- •Subject has any condition or factor which, in the Investigator's opinion, might increase the risk to the subject.
- •Subject is not expected to live more than 60 days.
研究组 & 干预措施
Dexmedetomidine
干预措施: Dexmedetomidine (Drug)
Placebo (PBO)
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of subjects who experienced any postoperative delirium up to 3 days after the end of study drug infusion
时间窗: Twice daily (between 6:00-9:00 AM and 5:00-8:00 PM) until 3 days after the end of study drug infusion.
The presence of postoperative delirium will be determined by Confusion Assessment Method for the Intensive Care Unit (CAM-ICU).
次要结局
- Duration of postoperative delirium as determined by CAM-ICU up to 3 days after end of study drug infusion(Twice daily (between 6:00-9:00 AM and 5:00-8:00 PM) until 3 days after the end of study drug infusion.)
- Percentage of subjects who experienced postoperative delirium each day after end of study drug infusion(Twice daily (between 6:00-9:00 AM and 5:00-8:00 PM) until 3 days after the end of study drug infusion.)
- Perioperative use of all analgesics (Fentanyl, Morphine, and oral analgesics)(During the intraoperative period, Post-anesthesia care unit period and the 3 days Follow-up Period.)
- Postoperative use of Midazolam(During the PACU period (Approximately 2 hours))
- Time-to-Aldrete score of ≥9(Every 15±5 minutes from arrival in the PACU (Approximately 2 hours))
- Length of post-operative hospital stay(From the post operative period until subject discharged from hospital)