EEG-Guided Analgesia for Delirium
(ALPHA-DEX Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if adjusting anesthesia based on brain activity can improve recovery for older adults after surgery. Researchers focus on how certain pain medications affect brain waves during surgery and whether this reduces confusion or delirium afterward. Participants will receive different types of anesthesia management, including standard care and personalized adjustments, known as "Alpha Optimization." Individuals aged 60 or older, who can give consent, and are scheduled for a planned surgery lasting at least two hours (excluding head or neck procedures) may be eligible. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance surgical recovery for older adults.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you use opioids for chronic pain or take certain medications like carbamazepine or phenytoin, you cannot participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that using EEG, a test that measures brain activity, to guide anesthesia can help adjust the amount of pain medication and anesthetic gas during surgery. Previous studies have examined how this method affects patient safety and recovery.
One study examined how changing anesthesia based on EEG readings could reduce complications, such as breathing or heart issues, during surgery. The results suggested that this approach might improve patient recovery after surgery. Another study found that using technology to personalize anesthesia can enhance patient safety and recovery.
These studies support the idea that EEG-guided anesthesia is generally well-tolerated and may aid in managing recovery after surgery. While more research is always helpful, current findings indicate that this approach is safe for use in humans.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores a novel approach to optimizing anesthesia for better recovery in older patients. Unlike standard practices that don't tailor the depth of anesthesia based on real-time brain activity, this method uses EEG-guided titration to adjust anesthetic and opioid levels. By focusing on individual brainwave patterns, the hope is to enhance early neurocognitive recovery, potentially reducing postoperative confusion and cognitive decline. This personalized technique could set a new standard in anesthesia care, especially for older adults who are more vulnerable to anesthesia-related cognitive issues.
What evidence suggests that this trial's treatments could be effective in reducing delirium following surgery?
Research has shown that monitoring brain activity, specifically alpha waves, during surgery might aid recovery. Studies have found a link between stronger alpha waves and better post-surgery recovery. For instance, higher alpha wave activity under anesthesia is associated with a lower risk of delirium, a state of confusion some experience after surgery. One study discovered that older adults with stronger alpha waves required less anesthesia, potentially leading to an easier recovery. This trial will compare different approaches, including Alpha Optimization and Routine Care, to determine if adjusting anesthesia based on alpha waves can help patients recover more smoothly after surgery.16789
Who Is on the Research Team?
Paul S. Garcia, MD, PhD
Principal Investigator
Columbia University
Are You a Good Fit for This Trial?
This trial is for adults aged 60 or older who can consent to participate, are having elective non-cardiac surgery (not involving the head or neck) with general anesthesia planned for at least 2 hours. It's not for those who refuse participation, use illicit substances or excessive alcohol, have chronic pain needing opioids, or take enzyme inducers like carbamazepine.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo EEG-guided analgesic titration during general anesthesia to improve early neurocognitive recovery
Postoperative Monitoring
Participants are monitored for delirium and pain in the PACU using 3D-CAM, CAM-ICU, and NRS assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Alpha Optimization
- Emergence from anesthesia with propofol
Trial Overview
The study aims to determine if adjusting analgesic medication based on EEG alpha power during anesthesia can reduce delirium after surgery. Participants will emerge from anesthesia using a drug called Dexmedetomidine while optimizing their brain's alpha waves.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
During the first randomization, participants randomized to intraoperative oscillatory EEG alpha optimization will receive individualized titration of anesthetic gas and opioids.
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.
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 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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Columbia University
Lead Sponsor
Citations
Intraoperative Frontal Electroencephalogram Alpha Power Is ...
Our primary outcome was postoperative mortality, extracted from the patient's electronic health record or the State of Massachusetts death registry, and ...
Lower alpha frequency of intraoperative frontal EEG is ...
A strong age-dependent negative correlation has been reported between the peak oscillatory frequency of alpha waves and end-tidal anesthetic concentration, with ...
Modulation Of Frontal EEG Alpha Oscillations During ...
Intraoperative monitoring of frontal electroencephalogram (EEG) has been associated with postoperative delirium and poor outcomes. However, the efficacy of ...
4.
anesthesiaexperts.com
anesthesiaexperts.com/intraoperative-frontal-eeg-alpha-power-post-operative-mortality-adverse-outcomes/Intraoperative Frontal EEG Alpha Power is Associated with ...
Our primary outcome was post-operative mortality, measured from date of surgery to date of death or last follow-up. Secondary outcomes included ...
5.
frontiersin.org
frontiersin.org/journals/aging-neuroscience/articles/10.3389/fnagi.2020.593320/fullPropofol Requirement and EEG Alpha Band Power During ...
The objective of this present study is to evaluate the relationship between intraoperative EEG, especially the alpha band power, effective ...
Artificial intelligence in anesthesia and perioperative medicine
AI improves individualized treatment, patient safety and postoperative recovery through biomarker identification and anesthetic protocol optimization.
A 6-Year Retrospective Cohort Study
This study investigates perioperative complications as primary outcomes, focusing on respiratory, cardiovascular, and cerebrovascular issues, as ...
8.
researchgate.net
researchgate.net/publication/396751604_Artificial_Intelligence_In_Anesthesia_Management(PDF) Artificial Intelligence In Anesthesia Management
Objective: The objective of this study is to explore the role and perceptions of Artificial Intelligence (AI) in anesthesia management, ...
9.
fortunejournals.com
fortunejournals.com/articles/a-scoping-review-of-artificial-intelligence-in-perioperative-anesthesia-current-applications-challenges-and-roadmap-for-the-future.htmlA Scoping Review of Artificial Intelligence in Perioperative ...
Current research highlights the growing integration of AI in anesthesiology, spanning preoperative risk assessment, intraoperative management, and postoperative ...
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