The Effect of Target-Controlled Infusion (TCI) on Neurocognitive Functions in Postoperative Sedoanalgesia Management in Geriatric Patients Undergoing Major Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in neurocognitive function score (Mini-Mental State Examination,MMSE)
研究概览
简要总结
This prospective observational study aims to evaluate the effects of target-controlled infusion (TCI) on postoperative neurocognitive function in geriatric patients undergoing major non-cardiac surgery. Elderly patients are at increased risk of postoperative cognitive dysfunction due to physiological changes and anesthesia-related factors. In this study, sedation management with TCI will be compared to manual infusion. Neurocognitive function will be assessed at multiple time points using the Mini-Mental State Examination (MMSE), and sedation levels will be monitored with the Bispectral Index (BIS) and the Richmond Agitation-Sedation Scale (RASS). The study aims to provide insights into safer sedation practices and improved cognitive outcomes in elderly surgical patients.
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
- •Undergoing noncardiac, nonneurosurgical major surgery under general anesthesia
- •Monitored postoperatively in the intensive care unit
- •Provided informed consent to participate in the study
排除标准
- •Cardiac or neurosurgical procedures
- •Patients younger than 65 years
- •Glasgow Coma Scale < 8
- •No informed consent
- •Body mass index (BMI) > 35
- •Communication difficulties preventing cognitive testing
- •Known allergy to study medications
结局指标
主要结局
Change in neurocognitive function score (Mini-Mental State Examination,MMSE)
时间窗: Preoperative baseline (within 24 hours before anesthesia) to 72 hours postoperatively
Between-group difference in the change of Mini-Mental State Examination (MMSE) total score from baseline to 72 hours after surgery, comparing target-controlled infusion (TCI) versus manual infusion. The MMSE is a widely used cognitive screening tool with a total score range of 0 to 30, where higher scores indicate better cognitive function.
次要结局
- Total sedative and analgesic drug consumption(From admission to the intensive care unit (ICU) until completion of the postoperative sedation period (approximately 0-72 hours postoperatively).)
- Hospital length of stay(From the day of surgery until hospital discharge (up to 40 days).)
研究者
Namigar Turgut
Professor of Anesthesiology and Intensive Care
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization