EEG-Guided Analgesic Titration During General Anesthesia to Improve Early Neurocognitive Recovery in Older Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Change in Frontal Alpha Power
研究概览
简要总结
The investigators intend to recruit 600 participants to see if alpha power during anesthesia is influenced by analgesic medication and associated with a reduction of delirium following surgery.
详细描述
Postoperative delirium may manifest in the immediate post-anesthesia care period. Such episodes appear to be predictive of further episodes of inpatient delirium and associated adverse outcomes. Intraoperative monitoring of frontal electroencephalogram (EEG) has been associated with postoperative delirium and poor outcomes. However, the efficacy of titrating anesthesia medication to proprietary index targets for preventing delirium remains contentious. The investigators aim to assess the efficacy of two pharmacologic strategies which could prevent post-anesthesia care unit (PACU) delirium (1) maximization of intraoperative alpha power during maintenance and (2) switching anesthesia regimes during the emergence phases of anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 60 years or over
- •Has capacity to provide informed consent
- •Undergoing elective non-cardiac surgery, which does not involve the head or neck, with planned volatile-based general anesthesia of expected duration of at least 2 hours
排除标准
- •Chronic pain with opioid requirement or concurrent use of enzyme inducers, e.g. carbamazepine, phenytoin,
- •Illicit substance use or excessive alcohol intake
- •Refusal by patient or case anesthesiologist responsible for patient's care
研究组 & 干预措施
Maintenance-Alpha Optimization / Wake from Dexmedetomidine
During the first randomization, participants randomized to intraoperative oscillatory EEG alpha optimization will receive individualized titration of anesthetic gas and opioids.
干预措施: Alpha Optimization (Procedure)
Maintenance-Alpha Optimization / Wake from Dexmedetomidine
During the first randomization, participants randomized to intraoperative oscillatory EEG alpha optimization will receive individualized titration of anesthetic gas and opioids.
干预措施: Emergence from anesthesia with Dexmedetomidine (Behavioral)
Maintenance-Alpha Optimization / Wake from Sevoflurane
During the first randomization, participants randomized to intraoperative oscillatory EEG alpha optimization will receive real-time monitoring of alpha recordings and individualized titration of desflurane and opioid. During the second randomization, participants randomized to standard emergence from volatile anesthesia will be woken up per standard practice.
干预措施: Alpha Optimization (Procedure)
Maintenance-Routine Care / Wake from Dexmedetomidine
During the first randomization, participants randomized to standard of care will receive anesthesia per usual care with quantitative processed EEG index values and EEG wave forms.
干预措施: Emergence from anesthesia with Dexmedetomidine (Behavioral)
Maintenance-Routine Care / Wake from Sevoflurane
During the first randomization, participants randomized to standard of care will receive anesthesia per usual care with quantitative processed EEG index values and EEG wave forms. During the second randomization, participants randomized to standard emergence from volatile anesthesia will be woken up per standard practice.
结局指标
主要结局
Change in Frontal Alpha Power
时间窗: Up to 24 hours post-surgery
The EEG data collected during the study duration will be processed using a customized script. Frontal alpha power (i.e., the cumulative power in the EEG alpha range) will be extracted from the EEGs and analyzed to compare the groups for the differences in the frontal alpha power.
次要结局
- Incidence of PACU Delirium(Up to 24 hours post-surgery)
- Change in pain in PACU: numerical rating score (NRS)(Up to 24 hours post-surgery)
研究者
Paul Garcia
Associate Professor of Anesthesiology
Columbia University