Impact of Propofol Versus Sevoflurane on Incidence of Postoperative Delirium in Elderly Patients After Spine Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 298
- 试验地点
- 2
- 主要终点
- Incidence of delirium after surgery
研究概览
简要总结
Postoperative delirium in older adults is a common and costly complication after surgery. Propofol and sevoflurane are commonly used anesthetics to maintain sedation during spine surgery, and have different sedative and anti-inflammatory effects. The aim of this trial will be compare the impact of propofol versus sevoflurane on incidence of postoperative delirium in elderly patients after spine surgery.
详细描述
Spine surgery is the third most common surgical procedure in older patients. With the increasing number of older patients undergoing spinal surgery, the risk of delirium after spinal surgery is currently expected to increase. The pathophysiological mechanisms of delirium remain poorly understood, leading models include neurotransmitter imbalance and neuroinflammation. Among precipitating factors, drugs (especially sedative hypnotic agents and anticholinergic agents), surgery, anesthesia, high pain levels, anemia, infections, acute illness, and acute exacerbation of chronic illness are the most commonly reported. Propofol and sevoflurane are commonly used anesthetics to maintain sedation during spinal surgery, and induce unconsciousness through different mechanisms. Meanwhile, previous studies have found that propofol and sevoflurane have different anti-inflammatory effects. Given their different sedative and anti-inflammatory effects, propofol and sevoflurane may have different effects on postoperative delirium. There are many studies to explore the effects of propofol and sevoflurane on postoperative delirium, but the conclusions are controversial. Therefore, a randomized, controlled, double-blind clinical study was designed to compare the impact of propofol and sevoflurane on delirium after spine surgery in elderly patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 否
入选标准
- •age ≥65 years and ≤90 years;
- •scheduled to undergo surgery for spinal, under general anaesthesia;
- •American Society of Anesthesiology (ASA) I-III;
- •agree to participate, and give signed written informed consents.
排除标准
- •family history or history of malignant hyperthermia;
- •History of propofol or sevoflurane allergy;
- •demonstrated cognitive impairment on the modified Mini-Mental State Examination (score, <24of 30 or <20 of 30 if the patient's education year was less than 6 years or<17 if the patient is Illiterate);
- •planned postoperative intubation or transferred to ICU;
- •severe visual or auditory handicap;
- •prior diagnoses of neurologic diseases or mental disorders (e.g., stroke, Parkinson's disease, dementia, schizophrenia, or depressive illness)
- •take anticholinergic drugs or other drugs acting on the central nervous system for a long time before operation
- •participating in other clinical studies in recent 3 months
研究组 & 干预措施
propofol group
For patients in the propofol group, anaesthesia will be maintained with propofol infusion(target controlled infusion), of which the target concentration will be adjusted to maintain the BIS value between 40 and 60. Analgesia will be maintained with remifentanil(0.1-0.5ug/(kg.min)), muscle relaxation will be maintained with atracurium(10ug/(kg.min)). Propofol infusion will be stopped at the end of surgery.
干预措施: propofol infusion (Drug)
sevoflurane group
For patients in the sevoflurane group, anaesthesia will be maintained with sevoflurane inhalation, of which the concentration will be adjusted to maintain the BIS value between 40 and 60. Analgesia will be maintained with remifentanil(0.1-0.5ug/(kg.min)), muscle relaxation will be maintained with atracurium(10ug/(kg.min)). Sevoflurane inhalation will be stopped at the end of surgery.
干预措施: sevoflurane inhalation (Drug)
结局指标
主要结局
Incidence of delirium after surgery
时间窗: Between postoperative day 1 to discharge or day 7, whichever came first
Delirium is assessed twice daily (8-10 AM and 6-8 PM ) with the 3 minute diagnostic interview for Confusion Assessment Method.Researchers will review all progress notes and nursing documentation for delirium diagnoses, and a thorough medical record review process using the Chart-based Delirium Identification Instrument.
次要结局
- The types of delirium in patients who developed delirium(Between postoperative day 1 to discharge or day 7, whichever came first)
- The intubation time in postanesthesia care unit (PACU)(From the patient transfered into PACU to tracheal extubation. Within 24 hours after surgery.)
- The day of postoperative delirium duration among patients who developed delirium(Time from first to last delirium-positive day. Between postoperative day 1 to discharge or day 7, whichever came first)
- The day of total delirium-positive days among patients who developed delirium(Between postoperative day 1 to discharge or day 7, whichever came first)
- The length of stay in in postanesthesia care unit (PACU)(Within 24 hours after surgery.)
- Postoperative nausea and vomiting(Up to 3 days after surgery)
- Incidence of emergence agitation(EA)(Emergence agitation will be assessed immediately after extubation. Within 24 hours after surgery.)
- Intensity of pain within 3 days after surgery(Up to 3 days after surgery)
- Incidence of postoperative shivering in PACU(Within 24 hours after surgery.)
- The incidence of non-delirium complications within 30 days after surgery(Up to 30 days after surgery)
- Postoperative recovery quality(The first day(6-8 PM) after surgery)
- Length of stay in hospital after surgery(Up to 30 days after surgery)
研究者
Lili Cao
professor
Qianfoshan Hospital