The Effect of HbA1c on Perioperative Neurocognitive Disorders in Patients Undergoing Elective Non-cardiac Surgery Under General Anesthesia.
试验速览
- 阶段
- 不适用
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Incidence of Postoperative Neurocognitive Disorders assessed with CAM
研究概览
简要总结
Preliminary evidence suggest a possible relationship between HbA1c and perioperative neurocognitive disorders (NCD). We are going to investigate whether the preoperative value of HbA1c in patients undergoing elective non-cardiac surgery under general anesthesia, are related with increased risk of perioperative NCD.
详细描述
It is estimated that approximately 10% of elderly undergoing surgery will develop cognitive changes perioperatively, while in some reports the incidence rises up to 80%. Despite the reported high prevalence of perioperative neurocognitive disorders (NCD), their exact etiology is still largely unknown.
Preliminary evidence suggest a possible relationship between HbA1c and perioperative neurocognitive disorders (NCD). We are going to investigate whether the preoperative value of HbA1c in patients undergoing elective non-cardiac surgery under general anesthesia, are related with increased risk of perioperative NCD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •45 - 80 years
- •American Society of Anesthesiologists physical status I to III
- •elective general, urological, gynecological and orthopedic surgery under general anesthesia
- •native speakers of the Greek language
排除标准
- •refused to participate or sign the informed consent form
- •had undergone surgery or anesthesia within the last 30 days
- •had any prior or current history involving an affliction of the central nervous system
- •were diagnosed with severe cognitive decline based on the 16 - item Informant Questionnaire on Cognitive Decline (IQCODE - 16)
- •suffered from severe hearing or visual impairment
- •any psychiatric disorder
- •had a score >5 in the Geriatric Depression Scale (GDS - 15)
- •or a score in females < 4 males < 2 in the Lawton - Brody Instrumental Activities of Daily Living Scale (I.A.D.L.)
- •reported alcohol consumption > 35 units/week
- •drug dependence
- •had undergone previous neuropsychological testing
- •Diabetes Mellitus type II with > 10 years of diagnosis
- •Diabetes Mellitus type I
- •Hemoglobin A1c (HbA1c) > 7.5%
- •suffered from hemodynamical instability (> 20% alterations of blood pressure perioperatively)
- •or desaturation (one or more events of SpO2 < 80% for more than 2 minutes) peri-operatively
- •or blood loss of more than one unit
结局指标
主要结局
Incidence of Postoperative Neurocognitive Disorders assessed with CAM
时间窗: 1st postoperative day
Screening for POD assessed with CAM
Incidence of Postoperative Neurocognitive Disorders with IQCODE-16
时间窗: 9 months postoperatively
Screening for POCD with IQCODE-16
次要结局
未报告次要终点
研究者
Elena Arnaoutoglou
Professor of Anesthesiology
University of Thessaly