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临床试验/NCT04963036
NCT04963036Unknown不适用

Impact of Nociception Level (NOL)-Guided Remifentanil Infusion and Entropy-guided Propofol Infusion on Intraoperative Arterial Pressure and Vasopressor Necessity A Prospective, Randomized, Controlled Trial.

Centre Hospitalier Universitaire Saint Pierre2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年7月28日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
2
主要终点
Occurrence of intraoperative hypotension

研究概览

简要总结

The aim of this study is to determine if Nociception Level (NOL)-guided Remifentanil analgesia, combined with Entropy-guided Propofol anesthesia, has a significant beneficial effect on the incidence of intraoperative hypotension episodes and/or on vasopressor requirements, during long-lasting major surgeries for high risk patients. The investigator will also investigate the effects of guided anesthesia on postoperative Myocardial Injury in Non-cardiac Surgery (MINS) and Postoperative cognitive dysfunction (POCD), amongst other frequent postoperative complications, in this population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elective high-risk head and neck or maxillo-facial surgery

排除标准

  • Patient refusal
  • Reduced ejection fraction below 40% and heart failure
  • History of atrial Fibrillation, pulmonary embolism, recent cardioversion, recent cardiac ischemic episode, chronic hypotension, chronic kidney insufficiency (serum creatinine > 1.5)
  • Septic state
  • Baseline heart-rate < 50 or > 90 bpm
  • History of psychiatric disease or medication

结局指标

主要结局

Occurrence of intraoperative hypotension

时间窗: during surgery

Occurrence of intraoperative hypotension is defined by at least 1 minute under the hypotension thresholds. Moderate and Severe Hypotension are respectively defined as a Mean Blood Pressure \<65 mmHg or \<55 mmHg and \<75 or \<65 mmHg for patient with history of chronic hypertension

Number of interventions to cure intraoperative hypotension

时间窗: during surgery

Number of vasopressor boli or vasopressor infusion dose adjustments

Total Time under hypotension thresholds

时间窗: during surgery

Hypotension Thresholds ( \<65 mmHg or \< 75mmHg for patient with history of chronic hypertension)

Total Vasopressor Dose

时间窗: during surgery

Total Vasopressor Dose used throughout the intervention to maintain Arterial Pressure within a pre-defined individualized ranges (≥ 65 mmHg or ≥75 mmHg for patient with history of chronic hypertension, and ≤ 100 mmHg)

次要结局

  • Postoperative Cognitive Decline (POCD)(up to 6 months after surgery)
  • Dosage of Stress Hormones(up to 4 hours after surgery)
  • Myocardial Injury in Non-Cardiac Surgery (MINS) marker (Troponin T)(up to 48 hours after surgery)
  • Olfactory Function assessment as an indicator of Neuro-Inflammation(up to 48 hours after surgery)
  • Adverse Event (blood loss, infection)(up to 15 Days after surgery)
  • Postoperative Acute Kidney Injury (AKI) marker (creatinin/Glomerular Filtration Rate)(up to 48 hours after surgery)
  • PostOperative Delirium (PO Delirium)(up to 6 months after surgery)
  • Dosage of Neuro-Inflammatory Markers(up to 48 hours after surgery)
  • Length of Intensive Unit Care (IUC) stay(up to 10 Days after surgery)
  • Length of hospital stay(up to 15 Days after surgery)

研究者

发起方
Centre Hospitalier Universitaire Saint Pierre
申办方类型
Other
责任方
Sponsor

研究点 (2)

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