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EEG Monitoring for Anesthesia in Aging

N/A

Waitlist Available

Led By Patrick L. Purdon, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Candidates scheduled for open or laparoscopic general surgical procedures under general anesthesia

American Society of Anesthesiologists (ASA) physical status classification of I, II or III

Must not have

Prior history of psychiatric or neurological diseases including schizophrenia, Parkinsonism, epilepsy or seizure, brain injury, brain tumors/metastases, encephalitis, stroke, CVA, TIA

Severe obesity (BMI ≥40 kg/m2)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up on postoperative day 1

Awards & highlights

No Placebo-Only Group

Summary

This trial is exploring whether monitoring brain waves could help anesthesiologists deliver anesthesia more precisely, specifically in elderly patients.

Who is the study for?

This trial is for people aged 65 or older who are fluent in English and scheduled for surgery under general anesthesia. They must be generally healthy (ASA I-III) with no cognitive impairment, dementia, severe obesity, MRI contraindications like metal implants, or a history of significant neurological or psychiatric conditions.

What is being tested?

The study is looking at how brain wave patterns during anesthesia (alpha oscillation dynamics) relate to brain images and aging. Participants will have their EEG monitored during surgery to see if these signals can predict changes in the brain associated with getting older.

What are the potential side effects?

Since this trial involves standard procedures already used in surgeries (EEG monitoring and MRI), side effects are minimal but may include discomfort from wearing the EEG cap or lying still for an MRI scan.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for surgery under general anesthesia.

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My overall health is good to moderately impaired.

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I am 65 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of serious brain or psychiatric conditions.

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My BMI is 40 or higher.

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I have a hearing or visual impairment.

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I have been diagnosed with Alzheimer's Disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one week before the surgery and postoperative day 7

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one week before the surgery and postoperative day 7

This trial's timeline: 3 weeks for screening, Varies for treatment, and one week before the surgery and postoperative day 7 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Intraoperative Burst Suppression Time

Postoperative Cognitive Decline

Postoperative Delirium Incidence

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Treatment GroupActive Control1 Intervention

Anesthesiologists in the treatment group use the unprocessed EEG waveforms and EEG spectrogram to maintain appropriate levels of unconsciousness for general anesthesia while avoiding burst suppression.

Group II: Control GroupActive Control1 Intervention

Anesthesiologists managing patients assigned to the control group will manage each anesthetic based on their clinical judgment, using standard monitoring required by American Society of Anesthesiologists (ASA), which include cardiac and respiratory monitoring, but not EEG monitoring.

0 / 7Eligibility criteria met