EVALUATION OF OPIOID CONSUMPTION USING OBJECTIVE NOCICEPTIVE MONITORING IN PATIENTS INDICATED FOR DEEP SEDATION IN THE INTENSIVE CARE UNIT
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Sedation variables:Respiratory, hemodynamic, neuromonitoring, and infectious status variables.
研究概览
简要总结
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Evaluate the consumption of intravenous opioids in patients indicated for deep sedation and the use of neuromuscular relaxants with inhaled sedation monitored with NOL versus without objective nociception monitoring.
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Evaluate the consumption of intravenous opioids in patients indicated for deep sedation and the use of neuromuscular relaxants with inhaled sedation monitored with NOL versus patients with intravenous sedation and nociception monitoring.
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Evaluate the consumption of intravenous opioids in patients indicated for deep sedation and the use of neuromuscular relaxants with intravenous sedation monitored with NOL versus patients with intravenous sedation and without nociception monitoring.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes aged ≥ 18 years
- •Indication for deep sedation (RASS < -4)
- •Need for neuromuscular relaxation. The use of neuromuscular blocking agents (NMBAs) in deep sedation in the ICU is indicated in situations requiring complete muscle paralysis to optimize mechanical ventilation and reduce oxygen consumption, such as ARDS, increased intracranial pressure (ICP), and status epilepticus. Prolonged use (>72h) should be avoided to prevent ICU-acquired weakness. In our unit, we primarily use cisatracurium (a non-depolarizing NMBA) as a continuous infusion at 1-4 mcg/kg/min and rocuronium (a non-depolarizing NMBA) as a bolus at 0.6-1.2 mg/kg or a continuous infusion at 4-12 mcg/kg/min. We monitor its administration using Train-of-Four (TOF) to prevent overdosing
- •Expected ICU stay of at least 72 hours.
- •Signed informed consent from the patient, family member, or legal representative.
排除标准
- •End-of-life situation or poor vital prognosis
- •Physical impossibility of monitoring with NOL.
- •Contraindications to NOL or sedation with isoflurane
结局指标
主要结局
Sedation variables:Respiratory, hemodynamic, neuromonitoring, and infectious status variables.
Sedation variables:Respiratory, hemodynamic, neuromonitoring, and infectious status variables.
次要结局
- Observed Adverse Effects Throughout the Study:- Time to awakening and presence/absence of delirium during the patient's awakening process. - ICU length of stay. - Hospital length of stay. - ICU mortality. - Hospital mortality- Opiodis abstincence
研究者
Marina Vila
Scientific
Hospital Universitari De Girona Doctor Josep Trueta