Comparative Efficacy and Safety of Propofol-Ketamine Combination Versus Propofol Monotherapy in Geriatric Patients Under Invasive Ventilation
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Mean arterial blood pressure
研究概览
简要总结
The study is a prospective randomized controlled trial comparing the efficacy and safety of propofol-ketamine ("Ketofol") versus propofol monotherapy in geriatric ICU patients. Eligible participants are critically ill elderly patients with a history of cardiac disease who require endotracheal intubation and have not yet received sedation. The investigators focus on a specific population in which geriatric patients have different pharmacokinetics and pharmacodynamics and are more prone to side effects than other populations.
Primary outcome: Incidence of hemodynamic instability (defined as hypotension requiring vasopressors), measured by mean arterial pressure (MAP) at baseline, during intubation, and post-intubation at 1, 5, 10, 30, and then every 8h for 24 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Age ≥ 65 years
- •Admitted to ICU with a diagnosis of infection (sepsis, septic shock, or pneumonia)
- •Known history of cardiac disease (e.g., ischemic heart disease, heart failure, arrhythmias)
- •Requiring endotracheal intubation for airway protection or respiratory failure
- •Informed consent obtained from patient or legal representative
- •Patient NOT on sedation prior randomization.
排除标准
- •Known allergy or contraindication to propofol or ketamine
- •Severe hepatic or renal dysfunction (Child-Pugh C, eGFR < 30 mL/min/1.73m²)
- •Uncontrolled hypertension (SBP > 180 mmHg or DBP > 110 mmHg)
- •Intracranial pathology (e.g., raised intracranial pressure, recent stroke, brain tumor)
- •Ongoing use of other sedative or anesthetic agents within 12 hours prior to intubation
- •Do-not-intubate or do-not-resuscitate orders
- •Participation in another interventional trial within the last 30 days
- •History of Psychosis
- •Severe Organ Dysfunction: Patients with Child-Pugh C hepatic failure
- •• Severe hypotension despite vasopressor therapy (systolic blood pressure < 100 mmHg or diastolic blood pressure < 70 mmHg)
研究组 & 干预措施
Ketofol Group (Ketamine + Propofol)
Patients will take bolus dose of Propofol 0.25 mg/kg + Ketamine 0.25mg/kg If patient NOT sedated and need additional doses will be given another Propofol 0.25 mg/kg + Ketamine 0.25mg/kg IV
干预措施: Ketofol (Drug)
Propofol group ( propofol monotherapy)
Patients will take Propofol lowest bolus dose of 0.5 mg/kg IV as monotherapy. If patient NOT sedated and need additional doses will be given another dose of 0.25 to 0.5 mg/kg after hemodynamically assessment
干预措施: propofol (drug) (Drug)
结局指标
主要结局
Mean arterial blood pressure
时间窗: baseline then at 1, 3, 5, 10, 20, 30, and 60 minutes, then hourly for 24 hours
hemodynamic stability, defined as MAP measured Baseline then during and post intubation at 1min , 3min , 5min 10min, 20min , 30min , 60min then hourly for 24h.
Mean arterial blood pressure
时间窗: baseline then at 1, 5, 10, , 30, and then every 8h for 24 hours
hemodynamic stability, defined as MAP measured Baseline then during and post intubation at 1min , 5min 10min, , 30min , then every 8h for 24h.
次要结局
- Time to successful intubation(within 1 hours)
- Heart Rate(within 1 hours)
研究者
Mujtaba Alqaisoum
Principal Investigator
Helwan University