Impact of Desflurane Versus Sevoflurane Anesthesia Maintenance Methods on Incidence of Postoperative Delirium in Elderly Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 890
- 试验地点
- 1
- 主要终点
- postoperative delirium
研究概览
简要总结
Advanced age is a consistent risk factor for the incidence of postoperative cognitive decline, which is associated with longer hospital stays, decreased quality of life, and increased mortality. Anaesthetic drugs can also affect postoperative cognition, as their residual effects can alter central nervous system activity. Desflurane and sevoflurane are widely used volatile anesthetics. Choice anesthetics may influence the occurrence of postoperative delirium. However, evidence in this aspect is conflicting.
详细描述
With increasing life expectancy, more and more patients aged 65 or older will receive general anesthesia. Rapid recovery from anesthesia may reduce the incidence of many postoperative complications, such as postoperative delirium and cognitive dysfunction. Using inhalational anesthetics is the mainstay of general anesthesia. Since they pass readily into the brain, anesthetics are usually recognized as the important cause of postoperative cognitive dysfunction. Studies have shown that inhalation anesthesia may increase the risk of postoperative delirium in elderly patients compared to propofol, but such studies mostly focus on isoflurane and sevoflurane. Concentrations isoflurane caused aggregation of amyloid peptides in cell cultures, indicating that they brought cytotoxicity to the brain; sevoflurane also showed the same cytotoxic effect. However, some studies showed that inhalational anesthetics had a protective effect on postoperative cognitive function. Desflurane is currently known to be the least biotransformation inhaled anesthetic, whose blood-gas partition coefficient is only 0.42. Desflurane is increasingly used in elderly patients in clinical practice. However, it is not clear whether general anesthesia maintained mainly by desflurane reduces postoperative delirium and early cognitive dysfunction compared with sevoflurane-based general anesthesia
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 65 years and < 90 years;
- •Scheduled to undergo non-cardiac or non-neurosurgery with an expected duration of 2 hours or more, under general anesthesia;
- •Agree to participate, and give signed written informed consent.
排除标准
- •Preoperative history of schizophrenia, epilepsy, parkinsonism or any diseases of central nervous system;
- •Inability to communicate in the preoperative period (coma, dementia, language barrier, impaired hearing or vision);
- •Severe diseases in cardiovascular, respiratory, liver, kidney, or preoperative American Society of Anesthesiologists physical status classification ≥ IV;
- •Alcoholism and drug dependence;
- •Other reasons that are considered unsuitable for participation by the responsible surgeons or investigators (reasons must be recorded in the case report form).
研究组 & 干预措施
Sevoflurane group
Sevoflurane will be administered by inhalation for anesthesia maintenance. The concentration of inhaled sevoflurane will be adjusted to maintain the bispectral index (BIS) value between 40 and 60. Analgesia will be supplemented with remifentanil, sufentanil. Sevoflurane inhalation will be stopped at the end of surgery.
干预措施: Sevoflurane (Drug)
Desflurane group
Desflurane will be administered by inhalation for anesthesia maintenance. The concentration of inhaled sevoflurane will be adjusted to maintain the BIS value between 40 and 60. Analgesia will be supplemented with remifentanil, sufentanil. Desflurane inhalation will be stopped at the end of surgery.
干预措施: Desflurane (Drug)
结局指标
主要结局
postoperative delirium
时间窗: within 7 days after surgery
Delirium is assessed twice daily with the Confusion Assessment Method for patients without endotracheal intubation or the Confusion Assessment Method for the Intensive Care Unit for patients with endotracheal intubation.
次要结局
- Quality of recovery, QoR15 (Quality of Recovery 15)(The day before surgery and on the 7th day after surgery or discharge)
- Incidence of complications within 30 days(Up to 30 days after surgery)
- Incidence of postoperative cognitive dysfunction (POCD)(The day before surgery and on the 7th day after surgery or discharge)
- Subjective sleep quality (NRS) within 3 days after surgery.(Up to 3 days after surgery)
- Length of stay in ICU after surgery.(Up to 30 days after surgery)
- Length of stay in hospital after surgery.(Up to 30 days after surgery)
- Percentage of intensive care unit (ICU) admission after surgery.(Within 24 hours after surgery)
- Intensity of pain within 3 days after surgery(Up to 3 days after surgery)
研究者
Min Xu
Attending anesthesiologist，Department of Anesthesiology, West China Hospital, Sichuan University
West China Hospital