Does Optimized General Anesthesia Care Reduce Postoperative Delirium In Older Patients Undergoing Hip Fracture Repair?
概览
- 阶段
- 不适用
- 干预措施
- General anesthesia
- 疾病 / 适应症
- Hip Fractures
- 发起方
- University of Missouri-Columbia
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- Severity of Postoperative Delirium
- 状态
- 终止
- 最后更新
- 2年前
概览
简要总结
Postoperative delirium occurs in up to 65% of elders undergoing surgery for repair of a hip fracture and this complication is independently associated with increased morbidity, mortality, length of hospital stay, and placement in long-term care institutions. To date, the only intervention shown to be effective at minimizing postoperative delirium is a proactive geriatric consultation. This prospective randomized clinical trial will randomize 160 adults, aged 65 years or older, to either optimized general anesthesia or usual general anesthesia care for hip fracture surgery to determine if the optimized anesthesia management reduces the severity of postoperative delirium.
详细描述
Subjects will be randomized to one of two intraoperative anesthesia treatment groups: 1.) Usual care - the anesthetic management will be at the discretion of the anesthesia provider; or 1.) Optimal care - the intraoperative depth of anesthesia will be directed using a BIS monitor, blood pressure will be maintained within 20% of preoperative levels, and cerebral oxygenation will be maintained \> 60% during anesthesia. Subjects will be evaluated using the Confusion Assessment Method (CAM) for the first 5 postoperative days to determine if they experience postoperative delirium.
研究者
Quinn Johnson
Chair, Anesthesiology
University of Missouri-Columbia
入排标准
入选标准
- •Subject or legal representative has voluntarily signed the informed consent approved by the Institutional Review Board,
- •Hip fracture surgery scheduled under general anesthesia
- •Subject is 65 years or older on the day of surgery
排除标准
- •Inability to follow directions or comprehend the English language
- •Severe uncorrected visual or auditory handicaps
- •Delirium at screening or baseline
- •Emergency surgery
研究组 & 干预措施
Usual general anesthesia care
Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane
干预措施: General anesthesia
Usual general anesthesia care
Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane
干预措施: propofol
Usual general anesthesia care
Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane
干预措施: fentanyl
Usual general anesthesia care
Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane
干预措施: sevoflurane
Optimized general anesthesia care
The subjects will have general anesthesia with propofol, fentanyl, sevoflurane. In addition the subjects will be monitored with a depth of anesthesia monitor (BIS) and a cerebral oximeter (Foresight). These additional monitors will be used to direct care. BP management: Systolic BP will be maintained within 20% of baseline systolic BP variables.
干预措施: cerebral oximeter (Fore-Sight)
Optimized general anesthesia care
The subjects will have general anesthesia with propofol, fentanyl, sevoflurane. In addition the subjects will be monitored with a depth of anesthesia monitor (BIS) and a cerebral oximeter (Foresight). These additional monitors will be used to direct care. BP management: Systolic BP will be maintained within 20% of baseline systolic BP variables.
干预措施: depth of anesthesia monitor (BIS)
Optimized general anesthesia care
The subjects will have general anesthesia with propofol, fentanyl, sevoflurane. In addition the subjects will be monitored with a depth of anesthesia monitor (BIS) and a cerebral oximeter (Foresight). These additional monitors will be used to direct care. BP management: Systolic BP will be maintained within 20% of baseline systolic BP variables.
干预措施: BP management
Optimized general anesthesia care
The subjects will have general anesthesia with propofol, fentanyl, sevoflurane. In addition the subjects will be monitored with a depth of anesthesia monitor (BIS) and a cerebral oximeter (Foresight). These additional monitors will be used to direct care. BP management: Systolic BP will be maintained within 20% of baseline systolic BP variables.
干预措施: General anesthesia
Optimized general anesthesia care
The subjects will have general anesthesia with propofol, fentanyl, sevoflurane. In addition the subjects will be monitored with a depth of anesthesia monitor (BIS) and a cerebral oximeter (Foresight). These additional monitors will be used to direct care. BP management: Systolic BP will be maintained within 20% of baseline systolic BP variables.
干预措施: propofol
Optimized general anesthesia care
The subjects will have general anesthesia with propofol, fentanyl, sevoflurane. In addition the subjects will be monitored with a depth of anesthesia monitor (BIS) and a cerebral oximeter (Foresight). These additional monitors will be used to direct care. BP management: Systolic BP will be maintained within 20% of baseline systolic BP variables.
干预措施: fentanyl
Optimized general anesthesia care
The subjects will have general anesthesia with propofol, fentanyl, sevoflurane. In addition the subjects will be monitored with a depth of anesthesia monitor (BIS) and a cerebral oximeter (Foresight). These additional monitors will be used to direct care. BP management: Systolic BP will be maintained within 20% of baseline systolic BP variables.
干预措施: sevoflurane
Mini Mental State Exam
Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane
干预措施: sevoflurane
Mini Mental State Exam
Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane
干预措施: General anesthesia
Mini Mental State Exam
Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane
干预措施: propofol
Mini Mental State Exam
Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane
干预措施: fentanyl
Tested and Excluded
Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane
干预措施: General anesthesia
Tested and Excluded
Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane
干预措施: propofol
Tested and Excluded
Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane
干预措施: fentanyl
Tested and Excluded
Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane
干预措施: sevoflurane
结局指标
主要结局
Severity of Postoperative Delirium
时间窗: 5 postoperative days
Delirium Rating Scale-Revised-98 (DRS-R-98) is a 16-item clinician-rated scale with 13 severity items and 3 diagnostic items (maximum severity score of 39 points). Higher scores indicate more severe delirium; score of 0 indicates no delirium. Only the number of patients who had high scores on the DRS-R-98 are reported.
次要结局
- Number of Patients Who Experienced Postoperative Complications(3 months and 1 year)
- Number of Patients Who Presented With Postoperative Delirium(5 postoperative days)
- Perioperative Inflammatory Response(preoperative, day of surgery, and postoperative day 2)