Effect of Electroencephalography-guided Anesthesia on Neurocognitive Disorders in Elderly Patients Undergoing Major Non-cardiac Surgery: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 314
- 试验地点
- 2
- 主要终点
- Postoperative neurocognitive disorder day 1 (Yes/No); dichotomic result.
研究概览
简要总结
The objective of the study is to investigate, in patients aged 70 years and over undergoing major non-cardiac surgery, the effect of electroencephalic (EEG)-guided anesthesia on postoperative neurocognitive disorders when controlling for intraoperative nociception, personalized blood pressure targets and using full information provided by the processed EEG monitor (including burst suppression ratio, density spectral array and raw EEG waveform).
This prospective, randomized, controlled trial will be conducted in a single Canadian university hospital. Patients aged 70 years and over, undergoing elective major non-cardiac surgery will be included. The administration of sevoflurane will be adjusted to maintain a BIS value between 40 and 60, a suppression Ratio at 0%, a direct EEG display without any suppression time and a spectrogram with most of the EEG wave frequency within the alpha, theta and delta frequencies in the EEG-guided group. In the control group sevoflurane will be administered to achieve an age-adjusted minimum alveolar concentration of [0.8-1.2]. A nociception monitor will guide intraoperative opioids' infusion and individual blood pressure targets will be personalized in both groups. The primary endpoint is the incidence of neurocognitive disorder (NCD) at postoperative day 1 evaluated by the Montréal Cognitive Assessment. Secondary endpoints include the incidence of postoperative neurocognitive disorder at different timepoints and the evaluation of cognitive trajectories among EEG-guided and control groups.
详细描述
The main objective of the study is to investigate the effect of EEG-guided anesthesia aiming at reducing anesthetic administration and minimizing burst suppression on the EEG during general anesthesia on the incidence of NCD at postoperative day 1 in elderly patients (> 70 years old) undergoing major (expected duration > 1h) non-cardiac surgery compared to standard care.
Secondary objectives are to investigate the effect of EEG-guided anesthesia compared to standard care on:
- neurocognitive disorders at postoperative day 2, 7, 15, 30 and 90,
- perioperative cognitive trajectories,
- postoperative delirium,
- intraoperative consumption of volatile anesthetics, opioids and vasopressors,
- intraoperative hypotension (number of interventions to treat hypotensive events),
- cerebral hypoxemia (assessed by cerebral oximetry),
- cumulative burst suppression duration and cumulative low processed EEG values duration during anesthesia,
- awareness
- postoperative surgical and quality of life / recovery outcomes.
Tertiary objectives are to:
- explore the effect of EEG-guided anesthesia compared to standard care across and within subgroups including different categories of surgical, duration of surgery, preoperative frailty, preoperative presence of depressive symptoms, age and patients with preoperative neurocognitive disorder.
- explore the effect of a possible imbalance in risk factors for postoperative NCD between the two groups on the incidence of postoperative NCD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Only the anesthesiologist in charge in the operating room will be aware of treatment group
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 70 years of age or older,
- •Major gynecologic, abdominal, urologic, thoracic or orthopedic surgery via laparoscopy or laparotomy under general anesthesia - with or without concomitant use of regional or neuraxial anesthesia -,
- •Expected anesthesia time of more than 60 minutes,
- •Seen for assessment by internal medicine and/or anesthesiology at the preoperative clinic (CIEPC)
排除标准
- •Known diagnosis of dementia or other neurological, psychiatric, developmental or medical condition that resulted in documented severe cognitive impairment,
- •Emergency surgery,
- •Significant auditory or visual impairment that precludes participation in cognitive testing,
- •Known allergy or intolerance or other medical condition that precludes the use of prescribed general anesthesia protocol for this study,
- •Inability to communicate in French or English.
结局指标
主要结局
Postoperative neurocognitive disorder day 1 (Yes/No); dichotomic result.
时间窗: Postoperative day 1
The presence of postoperative neurocognitive disorder will be evaluated using the Montreal Cognitive Assessment The Montréal Cognitive Assessment range from 0 to 30, higher values corresponding to better cognitive performances. The preoperative mean and standard deviation of the Montréal Cognitive assessment will be calculated. An individual reduction of the MoCA score ≥ 1.96 standard deviation calculated on overall population preoperative mean will define postoperative neurocognitive disorder (Yes/No). Baseline cognitive testing will be performed before surgery, then repeated on postoperative day 1 (primary endpoint)
次要结局
- Postoperative delirium (Yes/No); dichotomic result(Postoperative days 1 and 2)
- Postoperative neurocognitive disorder day 90 (Yes/No); dichotomic result.(Postoperative day 90)
- Postoperative neurocognitive disorder day 30 (Yes/No); dichotomic result.(Postoperative day 30)
- Cognitive Trajectories: Evolution of T-MoCA over time (score /22 without unit)(Day 0,1, 2, 7, 15, 30, 90)
- Total Dose of Sevoflurane (unit: ml)(Intraoperative)
- Total cerebral hypoxemia duration (unit: minutes)(Intraoperative)
- Total low BIS values duration (unit: minutes)(Intraoperative)
- Postoperative neurocognitive disorder day 2 (Yes/No); dichotomic result.(Postoperative day 2)
- Postoperative neurocognitive disorder day 7 (Yes/No); dichotomic result.(Postoperative day 7)
- Postoperative neurocognitive disorder day 15 (Yes/No); dichotomic result.(Postoperative day 15)
- Total Dose of Phenylephrine (unit: mcg)(Intraoperative)
- Postoperative neurocognitive disorder evaluated on verbal fluency (Yes/No); dichotomic result.(Day 0,1, 2, 7, 15, 30, 90)
- Total Dose of Remifentanil (unit: mcg)(Intraoperative)
- Total hypotension duration (unit: minutes)(Intraoperative)
- Awareness (Yes/no); dichotomic result(Postoperative day 1)
- Total burst suppression duration (unit: minutes)(Intraoperative)
研究者
Philippe Richebe
MD, PhD, Full professor, chair of research anesthesia and pain medicine
Ciusss de L'Est de l'Île de Montréal