Evaluation of the Association Between Low-Flow and Normal-Flow Anesthesia and Postoperative Delirium in Elderly Patients Undergoing Hip Fracture Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 128
- 主要终点
- The incidence of postoperative delirium is lower in patients receiving low-flow anesthesia compared to those receiving normal-flow anesthesia.
研究概览
简要总结
The aim of this study is to investigate the relationship between low-flow and normal-flow anesthesia techniques and the development of postoperative delirium in elderly patients undergoing surgery for hip fracture.
详细描述
Materials and Methods:
Study Design and Ethical Approval:
This study is designed as a prospective observational study. Ethical approval has been obtained, and the study will be conducted in accordance with the principles of the Declaration of Helsinki. Written informed consent will be obtained from all patients enrolled in the study.
There will be no intervention or randomization by the investigators in the selection of patients; the choice between low-flow and normal-flow anesthesia will be left to the discretion of the attending anesthesiologist as per routine clinical practice. Patients aged ≥65 years who are admitted to SBÜ Gaziosmanpaşa Training and Research Hospital due to hip fracture and are scheduled for surgery will be included in the study.
This is a single-center study. Postoperative outcomes including the incidence and duration of delirium on postoperative days 1, 3, and 7, visual pain and sedation scores, length of hospital stay, and associated complications will be evaluated. Postoperative sedation will be assessed using the Richmond Agitation-Sedation Scale (RASS), and pain will be assessed using the Visual Analog Scale (VAS), both of which are part of routine hospital practice. In addition, the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) will be used to evaluate the presence of delirium in study participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients aged 65 years and older who are scheduled to undergo surgical treatment for hip fracture, classified as ASA physical status I-IV, and who have signed the informed consent form will be included in the study.
排除标准
- •Patients with complex fractures (multiple fractures, extremity, abdominal, pelvic or sacral trauma, head trauma, etc.), those with relative contraindications to general anesthesia (e.g., known difficult airway, malignant hyperthermia), patients requiring postoperative intubated intensive care follow-up, those with a history of dementia, sleep disorders, or psychosis, individuals with serious neurological diseases (e.g., Parkinson's disease, stroke sequelae), those with a history of opioid, alcohol, or substance use, patients with cerebrovascular disease, those who underwent surgery within the past 6 months, patients with hearing or vision impairment, bleeding disorders or those taking medications affecting coagulation, patients with hypoalbuminemia (<3 g/dL), preoperative anemia with hematocrit <30%, known allergy to anesthetic drugs, severe cardiopulmonary failure, immobility, malnutrition, or those who are unable to comply with the study protocol will be excluded from the study.
结局指标
主要结局
The incidence of postoperative delirium is lower in patients receiving low-flow anesthesia compared to those receiving normal-flow anesthesia.
时间窗: 7 days
次要结局
- 28-day mortality(28 days)
- Correlation Between NIRS Monitoring Values and Postoperative Delirium(7 days)
- Correlation Between BIS Values and Postoperative Delirium(First 7 postoperative days)
研究者
veysel Dinç
Assist. Prof.
Gaziosmanpasa Research and Education Hospital