Release of Serum Neurofilament Light (NFL), Biomarker of Neuronal Injury, in Surgery Under General Anaesthesia (GA) Compared to Surgery With Hypno-analgesia (Hyp): A Prospective, Non-inferiority Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Serum Neurofilament Light at first postoperative day (18 - 24 hours) postoperatively) between both groups
研究概览
简要总结
Experimental studies have shown that inhalational anesthetics may be neurotoxic by for example causing amyloid beta deposition. Otherwise a pre-clinical study reported an increase in tau phosphorylation with the use of propofol.
Whether anesthesia and surgery contribute to the development of long-term cognitive decline remains however controversial. A meta-analysis concluded that general anesthesia could increase the risk of postoperative cognitive decline (POCD) compared with regional or combined anesthesia but this was not shown for Postoperative delirium (POD). This conclusion should be interpreted with caution as these studies showed many shortcomings.
Currently no study has compared the release of Neurofilament Light, a biomarker of neuronal injury, in patients undergoing surgery under general anesthesia compared to surgery with Hypno-analgesia and thus without anesthetic drugs.
详细描述
POD and POCD are manifestations of cognitive dysfunction occurring in the perioperative period. Whether surgery and specifically anesthesia contribute to the development of perioperative cognitive dysfunctions is not clear.
Cell culture and animal studies have suggested detrimental effects of anesthetic exposure.1,2,3 Otherwise, it has been shown in animals that surgery plus anesthesia produced worse POCD than anesthesia alone.4 Proinflammatory cytokine levels increase during surgery. These elevated levels of inflammatory markers associated with the activation of microglial cells may induce neuroinflammation enhancing ongoing neurodegeneration.5 However, anesthetics may be capable of modulating inflammation and may alter the neuroinflammatory response.
Clinical studies associating the effects of general anesthesia with POCD and POD are conflicting.6 These varying results could be due to heterogeneity of patients' baseline status (e.g. cognitive status, education, associated diseases), type of surgery, as well as methods used to determine POCD and POD.
The use of serum neurobiomarkers, sensitive and specific for neuronal cell injury will address the hypothesis of general anesthesia neurotoxicity. Serum Neurofilament Light (NFL) is such a neurobiomarker.Currently no study has compared the release of Neurofilament Light, a biomarker of neuronal injury, in patients undergoing surgery under general anesthesia compared to surgery with Hypno-analgesia and thus without anesthetic drugs. Our hypothesis is that surgery under GA compared to hypnosis does not statistically increase the risk of neuronal injury as measured by serum NFL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients undergoing thyroid or breast cancer surgery and necessitating one night of hospital stay
排除标准
- •Renal insufficiency with a GFR < 30 mL/min
- •Mammectomy
- •Preoperative psychiatric problems
- •Patients not speaking fluently French
- •Patients at risk of postoperative hyperalgesia (Kalkman score > 4/15)
- •Allergy to local anesthetics, NSAID and to Rocuronium
- •Patients undergoing one day surgery
研究组 & 干预措施
General Anesthesia (GA)
Patients undergoing thyroid or breast cancer surgery under general anesthesia
干预措施: General anesthesia (Other)
Hypno-analgesia (Hyp)
Patients undergoing thyroid or breast cancer surgery under Hypno-analgesia; i.e.hypnosis combined with the use of analgesics.
干预措施: Hypno-analgesia (Other)
结局指标
主要结局
Serum Neurofilament Light at first postoperative day (18 - 24 hours) postoperatively) between both groups
时间窗: 18 hours to 24 hours postoperatively
Comparison of postoperative serum Neurofilament Light between both groups
次要结局
- Total postoperative analgesic consumption between both groups(24 hours postoperatively)
- Postoperative serum Neurofilament Light at postoperative day 8 - 10(Day 8 to day 10)
- Comparison of postoperative Montreal Cognitive Assessment on a scale of 30 (higher scores are better) between both groups(Day 8 to day 10)
- Quality of Recovery F15 questionnaire with 15 questions on a scale of 10 (higher scores are better) between both groups(Day 8 to day 10)
- Postoperative C-reactive protein between both groups(24 hours postoperatively)
- Postoperative serum Neurofilament Light in function of type of surgery(24 hours postoperatively)