2024-517749-15-00招募中4 期
LIDOCRIT : Effect of continuous intravenous LIDOCaine on discomfort in postoperative CRITical care inpatients
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 246
- 试验地点
- 9
- 主要终点
- Overall score on the IPREA questionnaire (Inconforts of REAnimation Patients with 18 items) carried out within 24 hours of discharge from critical care or, failing that, within 24 hours of the 30th day of hospitalisation in critical care
研究概览
简要总结
To determine whether continuous intravenous administration of Lidocaine during the first 48 hours post-operatively improves patients' perceived comfort during their stay in the intensive care unit and continuous monitoring unit (critical care)
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
- •Major patient
- •Patient admitted immediately post-operatively in critical care (scheduled or emergency admission, e.g. post-operative exploratory laparotomy, cardiac surgery, heavy orthopaedic surgery such as polytrauma patients, vascular surgery at risk of complications such as open aortic surgery)
- •Anticipated length of stay in critical care ≥ 48h
- •Membership of a social security scheme
- •Informed consent must be obtained and signed by the patient or by a close relative or legal representative or, failing that, the emergency procedure must be followed
排除标准
- •Weight over 100 kg
- •Stage IV/V chronic renal failure, not on dialysis
- •Severe hepatocellular insufficiency at inclusion (Child-Pugh C)
- •Bradycardia < 50 bpm on antiarrhythmic drugs
- •Clinical convulsive seizure at inclusion
- •Predictable inability to answer the questionnaire (cognitive impairment, non-Francophone)
- •Known participation in another interventional research study (RIPH1 or RIPH2)
- •Known situation of deprivation of liberty or legal protection (safeguard of justice, guardianship or curatorship)
- •Hypersensitivity to one of the active substances used for anaesthesia or to one of the excipients
- •Acute porphyria on anamnesis
- •Pregnant or breast-feeding women
- •Patient who has received or will receive peri-medullary analgesia intra-operatively or post-operatively
- •Patient who has received or will receive loco-regional analgesia intra-operatively or post-operatively
- •Severe head injury, open cephalic neurosurgery, interventional neuroradiology
- •Recovered cardiorespiratory arrest
- •Noradrenaline doses > 0.5 μg/kg/min
结局指标
主要结局
Overall score on the IPREA questionnaire (Inconforts of REAnimation Patients with 18 items) carried out within 24 hours of discharge from critical care or, failing that, within 24 hours of the 30th day of hospitalisation in critical care
Overall score on the IPREA questionnaire (Inconforts of REAnimation Patients with 18 items) carried out within 24 hours of discharge from critical care or, failing that, within 24 hours of the 30th day of hospitalisation in critical care
次要结局
- Result per item of 8 items of the IPREA score, carried out within 24 hours before discharge from critical care or, failing that, within 24 hours before the 30th day of hospitalisation in critical care: - Noise - Thirst - Pain - Medical devices (catheters, intubation tubes, etc.) - Sleepiness - Dyspnoea - Anxiety - Depression
- Cumulative opiate consumption over the first 6 post-operative days (in equivalent mg of IV morphine, or µg of Remifentanil or µg of Sufentanil)
- The duration of invasive mechanical ventilation in critical care (over a maximum period of 30 days post-operatively)
- Re-intubation within 48 hours of extubation (up to discharge from critical care or, failing that, up to the 30th postoperative day)
- The duration of sedation (until discharge from critical care or, failing that, the 30th postoperative day maximum)
- The length of stay in critical care, including, in the event of transfer, the stay in critical care in the transfer hospital, over a maximum period of 30 post-operative days
- The total length of hospital stay including, in the event of transfer, the stay in the transfer hospital, over a maximum period of 30 post-operative days
- Vital status on the 30th postoperative day
- The incidence of care-associated pneumonia (RFE SFAR/SRLF 2017 ‘Care-associated pneumonia’ criteria in appendix) during the critical care stay over a maximum of 30 post-operative days
- The incidence of delirium (measured by CAM ICU) during the critical care stay over a maximum of 30 days post-operatively
- The incidence of adverse reactions attributable to lidocaine over the duration of treatment administration and 24 hours after the end of treatment administration
研究者
Elodie MASSERET
Scientific
Centre Hospitalier Universitaire De Rennes
研究点 (9)
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