Anesthesia Maintenance With Target-controlled Infusion of Propofol and Remifentanil at Fixed Ratio on Neurocognitive Recovery in Older Patients After Surgery: a Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence of delayed neurocognitive recovery
研究概览
简要总结
The impact of anesthesia depths on early postoperative neurocognitive complications after total intravenous anesthesia (TIVA) remains controversial. In some studies investigating TIVA, anesthesiologists mainly achieve the target depth of anesthesia by adjusting the dose of propofol, whereas the doses of opioids remains comparable between different anesthetic depth groups, possibly resulting inadequate analgesia. This study is aimed to investigate the impact of different anesthesia depths maintained by target-controlled infusion of propofol and remifentanil at a fixed ratio on the incidence of early postoperative neurocognitive complications in older patients undergoing noncardiac surgery.
详细描述
Early postoperative neurocognitive complications are associated with worse perioperative and long-term outcomes, substantially affecting patients' prognosis and recovery and imposing a significant healthcare and economic burden. Bispectral index (BIS) is an objective and quantitative monitoring parameter used to assess patients' depth of anesthesia. Maintenance of general anesthesia under the guidance of BIS monitoring has been shown to reduce the incidence of early postoperative neurocognitive complications following inhalational anesthesia or combined intravenous-inhalational anesthesia.
However, the impact of different depths of anesthesia maintenance on early postoperative neurocognitive complications after total intravenous anesthesia (TIVA) remains controversial. In some studies investigating TIVA, anesthesiologists mainly achieve the target BIS by adjusting the dosage of propofol, whereas the dosage of opioids remains comparable between different anesthetic depth groups. Based on previous studies, the investigators supposed that target-controlled infusion of propofol to remifentanil at a fixed ratio might ensure adequate intraoperative sedation and analgesia and reduce postoperative neurocognitive complications.
This study is aimed to investigate the impact of different anesthesia depths by target-controlled infusion of propofol and remifentanil at a fixed effect-site concentration ratio on the incidence of early postoperative neurocognitive complications in older patients undergoing noncardiac surgery.
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)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 65 years.
- •Scheduled to undergo noncardiac surgery expected to last ≥ 1 hour under general anesthesia.
- •Require patient-controlled intravenous analgesia after surgery.
- •Provide written informed consent.
排除标准
- •Inability to communicate in the preoperative period because of coma, profound dementia, language barrier, or other reasons.
- •Previous history of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis.
- •Traumatic brain injury or neurosurgery.
- •Severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (eGFR <30 ml/min/1.73 m2), or critical illness (preoperative American Society of Anesthesiologists physical status classification ≥IV).
- •Planned ICU admission with endotracheal intubation after surgery.
- •Enrolled in the other studies.
- •Other reasons that are considered unsuitable for study participation by the responsible surgeons or investigators.
研究组 & 干预措施
Light anesthesia
Anesthesia will be maintained by target-controlled infusion of propofol and remifentanil at a fix ratio; the target BIS is 50.
干预措施: Light anesthesia (Drug)
Deep anesthesia
Anesthesia will be maintained by target-controlled infusion of propofol and remifentanil at a fix ratio; the target BIS is 35.
干预措施: Deep anesthesia (Drug)
结局指标
主要结局
Incidence of delayed neurocognitive recovery
时间窗: On day 4 or before hospital discharge after surgery.
Cognitive function is assessed with the Montreal Cognitive Assessment (MoCA; scores range from 0 to 30, with higher scores indicating better cognitove function). A decrease of 1 SD or more from baseline is defined as cognitive decline.
次要结局
- Quality of recovery after surgery(On days 1 and 3 after surgery)
- Incidence of postoperative neurocognitive disorder(On day 30 after surgery)
研究者
Dong-Xin Wang
Chief Physician, Professor
Peking University First Hospital