Alpha Optimization for Delirium

N/A

Waitlist Available

Led By Paul S. Garcia, MD, PhD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 hours post-surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a medication can reduce delirium after surgery by looking at brain waves during anesthesia.

Eligible Conditions

Postoperative Delirium

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 hours post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 hours post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 hours post-surgery for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of PACU Delirium

Secondary study objectives

Change in Frontal Alpha Power

Change in pain in PACU: numerical rating score (NRS)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Maintenance-Alpha Optimization / Wake from PropofolExperimental Treatment2 Interventions

During the first randomization, participants randomized to intraoperative oscillatory EEG alpha optimization will receive individualized titration of anesthetic gas and opioid. During the second randomization, participants randomized to conversion to a propofol infusion for emergence from anesthesia will received an infusion of propofol 400mg/h and simultaneous reduction of desflurane concentration during the final 10-20 minutes of surgery.

Group II: Maintenance-Routine Care / Wake from PropofolActive Control1 Intervention

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 conversion to a propofol infusion for emergence from anesthesia will received an infusion of propofol 400mg/h and simultaneous reduction of desflurane concentration during the final 10-20 minutes of surgery.

Group III: Maintenance-Routine Care / Wake from VolatileActive Control1 Intervention

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.

Group IV: Maintenance-Alpha Optimization / Wake from VolatileActive Control1 Intervention

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.

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