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 — PROCEDUREIntraoperative 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 — BEHAVIORALInfusion 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 DexmedetomidineDuring 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 SevofluraneDuring 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 DexmedetomidineDuring 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 SevofluraneDuring 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
- Paul S. Garcia, MD, PhD212-304-7678
- Tuan Z. Cassim, BA917-539-9926
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 |
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