Does Intra-operative Low End Tidal CO2 Aggravate Perioperative Neurocognitive Disorders?
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- T-MOCA-baseline
研究概览
简要总结
This prospective study is designed to examine the influence of intra-operative ventilation on perioperative neurocognitive disorders in patients undergoing total hip arthroplasty.
详细描述
Perioperative neurocognitive disorders (PND's) remain an important complication after surgery. After many years of speculating about the etiology of this complication, currently studies are pointing to an inflammatory cascade being set in motion. Following the combination of surgery/ anesthesia, high molecular group box protein 1 (HMGB1) is released. This damage-associated molecular pattern (DAMP) binds to pattern recognition receptors (PRR) on circulating bone marrow-derived monocytes (BM-DMs). Through an intracellular signaling pathway, the transcription factor NF-kappa B passes into the nucleus, is activated and increases expression and release of pro-inflammatory cytokines. These in turn disrupt the blood brain barrier. Within the brain parenchyma the chemokine monocyte chemoattractant protein 1 (MCP-1) is upregulated and attracts the BM-DMs through binding to its receptor, CCR2. In turn, this activates the resident quiescent microglia. Together, the BM-DMs and activated microglia release HMGB1 and pro-inflammatory cytokines that disrupt long-term potentiation (LTP) thereby blocking synaptic plasticity changes that are required for the cognitive functions of learning and memory.
Optimizing intraoperative ventilation has been the goal of many studies, which have suggested obtaining protective ventilation through the use of low tidal volumes (6-8 ml/kg) and driving pressure below 15 mm Hg.
Very few articles have focused on the influence of intra-operative ventilatory management on PND's.
This prospective study is designed to examine the influence of intra-operative ventilation on perioperative neurocognitive disorders in patients undergoing total hip arthroplasty.
The objectives in our study are to:
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Patients will be blinded to the group, as well as the outcomes assessor and the investigator.
The anesthesiologist responsible for the patient's anesthesia will not be blinded.
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an ASA (American Society of Anesthesia) score of I- III
- •Scheduled for total hip arthroplasty
排除标准
- •lack of local language comprehension
- •neuropsychiatric disturbance
- •history of drug/alcohol abuse
- •use of anticholinergic drugs, benzodiazepines, opiates/neuroleptic drugs
- •patients with an infectious disease within the last month/immune-suppressant therapy within the last 2 months (e.g., azathioprine or cyclosporine) or chronic medication with potential immune-modulatory effects
- •patients who underwent major surgery within the last 3 months
- •Patients with cardiovascular, or respiratory diseases (including smoking) resulting in clinically relevant impaired function
- •Patients with pre-existing CVA, dementia, and other neurological conditions that would interfere with their ability to participate cognitively
- •patients with active malignancy
结局指标
主要结局
T-MOCA-baseline
时间窗: 12 hours
In order to evaluate perioperative neurocognitive disorders, patients will take the T-MOCA test
T-MOCA-6-weeks-postoperatively
时间窗: 6 weeks
In order to evaluate perioperative neurocognitive disorders, patients will take the T-MOCA test
T-MOCA-3-months-postoperatively
时间窗: 3 months
In order to evaluate perioperative neurocognitive disorders, patients will take the T-MOCA test
次要结局
- Concentration of patient's post-operative peripheral IL-6; 6 hours post-operative(24 hours)
- Concentration of patient's baseline pre-operative peripheral IL-6(12 hours)
- Concentration of patient's post-operative peripheral IL-6 ; 24 hours post-operative(24 hours)
研究者
Sarah Saxena
Principal Investigator
Université Libre de Bruxelles