EEG-Guided Analgesic Titration During General Anesthesia to Improve Early Neurocognitive Recovery in Older Patients

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT04443517
Status
Not Yet Recruiting

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Conditions

  • Postoperative Delirium

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Alpha Optimization — PROCEDURE
    Intraoperative oscillatory EEG alpha optimization involves real-time acquisition of oscillatory alpha power from the frontal EEG with individualized titration of sevoflurane and opioid.
  • Emergence from anesthesia with Dexmedetomidine — BEHAVIORAL
    Infusion of .05 mcg/kg/h of propofol during the final 10-20 minutes of surgery.

Study Details

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.

Key Dates

Start date
Apr 1, 2026
Status verified
Jan 2026
Primary completion
Jun 1, 2030
Completion
Mar 31, 2031

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: 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.
  • Active Comparator: 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.
  • No Intervention: 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.

Primary Outcome Measure

Change in Frontal Alpha Power [ Time Frame: Up to 24 hours post-surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical CenterNew YorkNew York10032
Paul S. Garcia, MD, PhD
212-304-7678
Tuan Z. Cassim, BA
917-539-9926

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