CTRI/2025/10/095990尚未招募不适用
A Study to compare Bispectral index objective sedation scale versus Richmond agitation sedation scale (RAAS subjective scale) in critically ill mechanically ventilated patients for clinical evaluation
Department of Critical Care Medicine1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2025年10月22日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Sensitivity , Specificity, Positive predictive & negative predictive values of BIS and clinical sedation scales.
研究概览
简要总结
| Delirium being an independent risk factor for ICU mortality can result in over sedation, increased duration of mechanical ventilation and increased length of ICU stay. Sedatives are commonly administered to ICU patients to control agitation. Sedatives must be titrated to attain either light sedation (i.e., the patient is arousable and able to consciously obey simple commands) or profound sedation (i.e., the patient is unresponsive to noxious stimuli), contingent upon the patient’s clinical status and expected ICU length.Nonetheless, tools such as the Richmond Agitation–Sedation Scale (RASS) require subjective evaluation, potentially leading to measurement variability and subsequent clinical actions. The bispectral index (BIS) is an objective measure for evaluating levels of awareness, frequently employed as an anaesthetic tool, with its use also expanding to the intensive care unit (ICU). The existing published findings are insufficient to warrant the extensive use of the BIS in patients with organophosphorus poisoning presenting with delirium |
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant 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
- •1.Age 18 to 65 years and Mechanically ventilated for more than 48 hours.
- •2.Patients/ Parents/ Caregivers who are willing to give informed consent 3.Patients with renal and hepatic disorder for subgroup analysis.
排除标准
- •Head injuries
- •Required Deep (Barbiturate Coma) Sedation for Status Epilepticus.
- •3.Patients known to have any focal brain disease or abnormal electrical brain activities such as epilepsy .
结局指标
主要结局
Sensitivity , Specificity, Positive predictive & negative predictive values of BIS and clinical sedation scales.
时间窗: every 4 hourly till extubation
Correation between BIS and RASS.
时间窗: every 4 hourly till extubation
次要结局
- Whether BIS monitoring can reduce sedative dose requirements while preventing undersedation events.(total volume in ml of drug infused in the 24 h study period;.)
研究者
Dr Sathya Narayanan K
Bangalore Medical College and Research Institute, Bangalore
研究点 (1)
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