Cerebral hemodynamic effects of ketamine-propofol versus ketamine- dexmedetomidine sedation in mechanically ventilated patients with severe traumatic brain injury: A prospective randomized , double-blinded study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Time spent in Maintaining of Cerebral perfusion pressure above 60mm Hg during the
研究概览
简要总结
Aim : To compare the cerebral hemodynamics of Ketamine-Propofol with Ketamine-Dexmedetomidine in mechanically ventilated patients with severe TBI.
This thesis plan investigates sedation protocols in critically ill patients by comparing ketamine-propofol and ketamine-dexmedetomidine combinations. This study will be conducted in the Trauma Intensive Care unit (TICU) of Department of Anaesthesia and Intensive Care. PGIMER Chandigarh from may 2025-november 2025 after approval by Institute Ethics Committee and Clinical Trials Registry of India (CTRI) and written informed consent of patient relatives. The study addresses a lack of evidence regarding the synergistic effects of these drug pairings on hemodynamic stability, depth of sedation, and potential adverse outcomes. A total of 42 patients admitted with severe traumatic brain injury and requiring mechanical ventilation will be assessed for elligibility.
Employing a prospective, randomized design, it incorporates continuous monitoring of intracranial pressure (ICP), cerebral perfusion pressure (CPP), and other clinical parameters to evaluate outcomes.
Demographics will be recorded in the form of age, sex, body mass index (BMI), GCS at presentation, Marshall CT score and mode of injury.
Primary outcome is calculating the Time spent in Maintaining of Cerebral perfusion pressure above 60mm Hg during the first 48 hours of either sedative regimen. Nomral CPP range in 60-70mmHg. any change from this range will be labelled as CPP excursion,
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •a) Patients between age group 18 years to 65 years with severe TBI b) Severe TBI patients for conservative management c) Radiological evidence of raised ICP.
- •Marshall CT score more than 2.
排除标准
- •a) Patients with thrombocytopenia (platelet count less than 100000 per mm3) or coagulopathy(INR more than 1.5) b) Polytrauma with Injury severity Score more than 25 c) Patient with unstable hemodynamics d) Infection at the proposed site of ICP catheter insertion e) Patients included in the study who undergo decompressive hemicraniectomy in the course of ICU management.
结局指标
主要结局
Time spent in Maintaining of Cerebral perfusion pressure above 60mm Hg during the
时间窗: from admission till completion of 48hrs of sedative regimen
first 48 hours of either sedative regimen.
时间窗: from admission till completion of 48hrs of sedative regimen
次要结局
- GCS at discharge from ICU(upon discharge from ICU)
- Incidence of mortality(from admission till death/discharge)
- Duration of Cerebral perfusion pressure below normal values (CPP excursion)(Tfrom admission till completion of 48hrs of sedative regimen)
- Duration of Intracranial pressure above normal values (ICP crisis)(from admission till completion of 48hrs of sedative regimen)
- TCD Mean pulsatility index values more than 1.4 at pre-defined time interval(from admission till completion of 48hrs of sedative regimen)
- Emergency neurosurgical intervention as rescue measures.(from admission till death/discharge)
研究者
Dr Pritam Panigrahi
Post Graduate Institute of Medical Education and Research