2024-517770-14-00暂停4 期
Opioid-Free Analgesia In Intensive Care Unit : A Prospective, Monocentric, Randomized, Double-Blind, Feasibility Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- daily consumption of remifentanil between the 24th hour and the 48th hour after randomisation of patients admitted to the ICU and requiring at least 72 hours of mechanical ventilation
研究概览
简要总结
Compare daily remifentanil consumption, between the 24th hour and the 48th hour after randomization of ICU patients requiring at least 72 hours of mechanical ventilation, between patients following a standardized multimodal analgesia strategy without major opioids and patients following the conventional strategy
研究设计
- 分配方式
- Randomized
- 主要目的
- Standardized Multimodal Analgesia Strategy Without Major Opioids Vs Conventional Strategy
- 盲法
- Double (Subject, Carer, Monitor, Investigator, Analyst)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Patient hospitalized in ICU and requiring sedation-analgesia for mechanical ventilation
- •Patient undergoing mechanical ventilation for more than 2 hours and less than 24 hours.
- •Informed consent signed by the patient or his trusted person, legal representative, family member, curator or tutor, or emergency consent procedure
- •Patient affiliated to the French Government Public Health Insurance
- •Patient over 18 years old
排除标准
- •Patient already involved in a trial that might influence our primary endpoint
- •Patient in exclusion-period determined by another trial or study
- •Patient who is likely to be requiring less than 48 hours of mechanical ventilation
- •Patient with contraindication or allergies to at least one of the following medication : paracetamol, nefopam, tramadol, ketamine, remifentanil
- •Patient with hepatic insufficiency (defined as PT < 50%)
- •Parturient or breast-feeding patient
- •Patient suffering from moderate to severe Acute Respiratory Distress Syndrome (ARDS), with decreased PaO2/FiO2 ratio under 150mmHg after respiratory optimization (courant volume 6mL/kg and PEEP > 5mbar)
- •Patient requiring curare treatment
- •Patient requiring ICU after undergoing major surgery (laparotomy or thoracotomy)
结局指标
主要结局
daily consumption of remifentanil between the 24th hour and the 48th hour after randomisation of patients admitted to the ICU and requiring at least 72 hours of mechanical ventilation
daily consumption of remifentanil between the 24th hour and the 48th hour after randomisation of patients admitted to the ICU and requiring at least 72 hours of mechanical ventilation
次要结局
- Vital status at day 28 and day 90
- Opioid use at D90
- SOFA Score (Sepsis-related Organ Failure Assessment)
- Daily fuid intake in milliliter
- CAM ICU test
- Cumulative dose of remifentanil
- Number of lived days free of remifentanil
- Daily consumption of sedative drugs from inclusion to D28
- Number of live days free of mechanical ventilation
- Presence of one or more events of special interest or expected adverse events: constipation, bradycardia, bladder globe, nausea, vomiting, liver disturbance, serotonin syndrome
- Presence of pneumonia associated with mechanical ventilation
- Extubation failure and cause (reintubation within 48 hours of first extubation)
- Length of stay in the intensive care unit and in the hospital
研究者
Dr remy WIDEHEM
Scientific
Centre Hospitalier Universitaire De Nimes
研究点 (1)
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