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

NCT04443517 | Not Yet Recruiting

• 1 other identifier: AAAS4614
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Delirium

Keywords

EEG; General Anesthesia

Outcome Measures

Primary Outcomes (1)

• Change in Frontal Alpha Power

  The EEG data collected during the study duration will be processed using a customized script. Frontal alpha power (i.e., the cumulative power in the EEG alpha range) will be extracted from the EEGs and analyzed to compare the groups for the differences in the frontal alpha power.

  Up to 24 hours post-surgery

Secondary Outcomes (2)

• Incidence of PACU Delirium

  Up to 24 hours post-surgery

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

  Up to 24 hours post-surgery

Study Arms (4)

Maintenance-Alpha Optimization / Wake from Dexmedetomidine

EXPERIMENTAL

During the first randomization, participants randomized to intraoperative oscillatory EEG alpha optimization will receive individualized titration of anesthetic gas and opioids.

Procedure: Alpha Optimization; Behavioral: Emergence from anesthesia with Dexmedetomidine

Maintenance-Alpha Optimization / Wake from Sevoflurane

ACTIVE COMPARATOR

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.

Procedure: Alpha Optimization

Maintenance-Routine Care / Wake from Dexmedetomidine

ACTIVE COMPARATOR

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.

Behavioral: Emergence from anesthesia with Dexmedetomidine

Maintenance-Routine Care / Wake from Sevoflurane

NO 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.

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.

Maintenance-Alpha Optimization / Wake from Dexmedetomidine; Maintenance-Alpha Optimization / Wake from Sevoflurane

Emergence from anesthesia with Dexmedetomidine BEHAVIORAL

Infusion of .05 mcg/kg/h of propofol during the final 10-20 minutes of surgery.

Maintenance-Alpha Optimization / Wake from Dexmedetomidine; Maintenance-Routine Care / Wake from Dexmedetomidine

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 60 years or over
• Has capacity to provide informed consent
• Undergoing elective non-cardiac surgery, which does not involve the head or neck, with planned volatile-based general anesthesia of expected duration of at least 2 hours

You may not qualify if:

• Chronic pain with opioid requirement or concurrent use of enzyme inducers, e.g. carbamazepine, phenytoin,
• Illicit substance use or excessive alcohol intake
• Refusal by patient or case anesthesiologist responsible for patient's care

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Paul S. Garcia, MD, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul S. Garcia, MD, PhD

CONTACT

212-304-7678; pg2618@cumc.columbia.edu

Tuan Z. Cassim, BA

CONTACT

917-539-9926; tc3032@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: June 23, 2020
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): March 31, 2031
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)