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临床试验/NCT07037186
NCT07037186进行中(未招募)不适用

Impact of Diabetes on Burst-Suppressions During Intraoperative EEG in Elderly Patients: Correlation With Postoperative Delirium

Haseki Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
80
试验地点
1
主要终点
burst-suppression

研究概览

简要总结

This observational study aims to learn about the effects of diabetes mellitus in intraoperative electroencephalography (EEG) of elderly patients receiving general anesthesia. The main question it seeks to answer is:

Is there a relation between preoperative diabetes, intraoperative electroencephalogram suppression ratio, and postoperative delirium?

Participants aged over 65, receiving general anesthesia as part of their anesthesia plan for surgery of any kind, will be monitored with EEG and cerebral oximetry intraoperatively to record burst suppressions and questioned for delirium for 48 hours postoperatively.

详细描述

3 different patient groups will be observed: those who are diagnosed with diabetes and use oral antidiabetics, those who receive insulin therapy with a diagnosis of diabetes, and patients whose preoperative fasting glucose values are confirmed to be normal without a diagnosis of diabetes.

Patients over 65 who are scheduled for any surgery requiring general anesthesia for at least 30 minutes will be evaluated to detect their basal cognition status with a mini-cognition test and a preoperative anesthesia examination. In addition to routine monitoring, this patient group will also be monitored with electroencephalogram and cerebral oximetry.

Anesthesia induction and maintenance for each patient are applied according to the values here. In the maintenance of anesthesia, sevoflurane will be regulated according to 0.7-1 MAC (adjusted for age), and remifentanil infusion will be regulated according to PSI. Postoperative analgesia will be achieved with tramadol 1 mg/kg and Parol 10 mg/kg (IV) with a target pain score below 4. Each patient will be evaluated with a NUDESC score as a delirium score in the postoperative PACU and during 48 hours in the ward. Values such as suppression time and ratio, the subject of study in EEG recordings during anesthesia, can only be seen by transferring them to the computer with a transfer cable, so the evaluations will be blind. All data transfers will be done after the 48th hour.

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

入选标准

  • Patients over the age of 65 undergoing ASA I-IV receiving general anaesthesia
  • All elective surgery patients who are not laparoscopic and last longer than 30 minutes

排除标准

  • American Society of Anesthesiologists (ASA) grade V or VI
  • Whether the surgery is cranial or laparoscopic
  • Preoperative neuropsychiatric (dementia, epilepsy, etc.) disease or drug use
  • Previous cranial surgery or known vertebrobasilar insufficiency, carotid stenosis
  • Those with a pain score above 4 in the postoperative evaluation unit (PACU)
  • Patients with a 15% decrease in cerebral oxygenation from onset in oximetry monitoring during follow-up
  • Patients with bleeding greater than 20% of total body volume during follow-up
  • Patients with a decrease of more than 20% from their baseline systolic value (based on follow-up in the service) during follow-up
  • Those with hypercarbia or hypocarbia due to intraoperative ventilation insufficiency
  • Patients whose PSI value is reduced to a depth of 25, which is sufficient for anaesthesia, with anaesthetic drugs administered during anaesthesia induction or maintenance
  • Presence of preoperative cognitive dysfunction
  • Patients requiring postoperative intubation and intensive care follow-up

结局指标

主要结局

burst-suppression

时间窗: Perioperative

Burst suppression amount recorded during EEG monitorization under general anesthesia

次要结局

  • delirium(Perioperative)

研究者

发起方
Haseki Training and Research Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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