Effect of Prophylactic, Perioperative Propranolol on Peri- and Postoperative Complications in Patients With Post Traumatic Stress Disorder
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Hospital length of stay
研究概览
简要总结
Understanding what treatments may facilitate perioperative care of Veterans with posttraumatic stress disorder (PTSD) is of great importance to the U.S. health care system.
Patients with PTSD are characterized by elevated central nervous system catecholamine concentrations and exaggerated and prolonged adrenergic responses to stress stimuli. At present, there are no data on the effects of perioperative beta blocker therapy in patients with PTSD, despite the rising significance of PTSD in Veteran populations.
This prospective, double-blind study proposes to randomize 150 Veterans with PTSD scheduled for orthopedic, thoracic or vascular surgery at the San Francisco VA Medical Center to either a 14-day course of propranolol or placebo. This study will then follow these Veterans for a one-year period to evaluate the effects of the intervention on Veterans' surgical outcomes.
The investigators hypothesize that patients with PTSD randomized to the propranolol group will demonstrate a reduced incidence of perioperative and postoperative morbidity and mortality.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects scheduled for any surgical procedure under general anesthesia or combined general-regional anesthesia, with the exception of open-heart or intracranial surgery. Regional anesthesia includes: 1) Epidural anesthesia, 2) Sub-arachnoid block (spinal), or 3)any regional nerve block
- •Anticipated postoperative hospital admission (defined as at least one overnight hospital stay)
排除标准
- •Veterans will be excluded if:
- •They are on beta blocker therapy at the time of the preoperative baseline assessment
- •They report sensitivity or allergies to propranolol, or a history of PTSD exacerbation with prior propranolol therapy
- •Veterans who fulfill the AHA/ACC level I recommendation criteria for perioperative beta blocker therapy (e.g., metoprolol, atenolol) and should not be randomized to placebo group
- •Medical exclusions criteria: high grade heart block without pacemaker (all patients with 2nd and 3rd degree heart block), marked resting bradycardia (heart rate ≤ 55 beats per minute), blood pressure < 100 mmHg, uncompensated congested heart failure, severe hyperactive airway disease, and Raynaud's disease
- •Current use of medication that may involve potentially dangerous interaction with propranolol
- •Circumstances that, in the opinion of the principal investigator, would preclude participation in a study of this type (e.g. medical concerns or difficulty in long-term followup).
- •Open-heart surgery and intracranial surgery
研究组 & 干预措施
Placebo Group
干预措施: Placebo (Other)
Propranolol Hydrochloride
干预措施: Propranolol Hydrochloride (Drug)
结局指标
主要结局
Hospital length of stay
时间窗: Truncated at 30 days after admission to ICU
Measured using patient medical records
Postoperative delirium
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Measured using Confusion Assessment Method (CAM-CAM-ICU)
ICU length of stay
时间窗: Truncated at 30 days after admission to ICU
Measured using patient medical records
Postoperative renal dysfunction
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Measured using Serum Creatinine laboratory values
ICU Length of Stay
时间窗: Truncated at 30 days after admission to ICU
Measured using patient medical records
Hospital Length of Stay
时间窗: Truncated at 30 days after admission to ICU
Measured using patient medical records
Postoperative Delirium
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Measured using Confusion Assessment Method (CAM-CAM-ICU)
Postoperative Renal Dysfunction
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Measured using Serum Creatinine laboratory values
次要结局
- Pain unpleasantness(Participants will be followed from preoperative baseline to 1 year postoperative)
- Perioperative complications(Participants will be followed for the duration of hospital stay, an expected average of 1 week)
- Analgesics use(Participants will be followed from preoperative baseline to 1 year postoperative)
- Functional status(Participants will be followed from preoperative baseline to 1 year postoperative)
- Length of intubation and mechanical ventilation(Participants will be followed for the duration of hospital stay, an expected average of 1 week)
- Postoperative complications(Participants will be followed to 1 year postoperative)
- Pain intensity(Participants will be followed from preoperative baseline to 1 year postoperative)
- Quality of Life(Participants will be followed from preoperative baseline to 1 year postoperative)
- Sleep Quality(Participants will be followed from preoperative baseline to 1 year postoperative)
- Depression symptoms(Participants will be followed from preoperative baseline to 1 year postoperative)
- Post Traumatic Stress Disorder symptomatology(Participants will be followed from preoperative baseline to 1 year postoperative)
- 30-day, 3-month, and 1-year mortality(Participants will be followed from preoperative baseline to 1 year postoperative)
- Postoperative Neurocognitive Dysfunction Score(Participants will be followed from preoperative baseline to 1 year postoperative)
- Perioperative Complications(Participants will be followed for the duration of hospital stay, an expected average of 1 week)
- Pain Intensity(12 months)
- Pain Unpleasantness(12 months)
- Perioperative Opioids Use(Participants will be followed from preoperative baseline to 1 year postoperative)
- Required Mechanical Ventilation(Participants will be followed for the duration of hospital stay, an expected average of 1 week)
- Change in Posttraumatic Diagnostic Scale (PDS) PTSD Symptoms Severity Score(Baseline and 12 months)
- Change in Mental Component Summary (MCS) Scores From the Short Form-36 Questionnaire (SF-36)(Participants will be followed from preoperative baseline to 1 year postoperative)
- Change in Physical Component Summary (PCS) Scores From the Short Form-36 Questionnaire (SF-36)(Participants will be followed from preoperative baseline to 1 year postoperative)
- Change in Pittsburgh Sleep Quality Index (PSQI) Score(Participants will be followed from preoperative baseline to 1 year postoperative)
- Change in Beck Depression Inventory (BDI) Score(Participants will be followed from preoperative baseline to 1 year postoperative)
- 30-day, 3-month, and 1-year Mortality(Participants will be followed from preoperative baseline to 1 year postoperative)
- Postoperative Complications(Participants will be followed to 1 year postoperative)