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Behavioral Intervention
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
Study 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of PACU Delirium
Secondary outcome measures
Change in Frontal Alpha Power
Change in pain in PACU: numerical rating score (NRS)
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 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 III: 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 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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Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,424 Previous Clinical Trials
2,472,427 Total Patients Enrolled
1 Trials studying Delirium
325 Patients Enrolled for Delirium
Paul S. Garcia, MD, PhDPrincipal InvestigatorColumbia University
1 Previous Clinical Trials
325 Total Patients Enrolled
1 Trials studying Delirium
325 Patients Enrolled for Delirium
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment currently in progress for this medical trial?
"The information available on clinicaltrials.gov reveals that this trial is no longer recruiting participants, despite having been posted initially on January 1st 2022 and last edited on August 4th 2021. However, 154 other studies are currently searching for patients to join their trials."
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