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

NCT ID: NCT04443517

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-04-01
• Study Completion Date: 2031-03-31

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.

Detailed Description

Postoperative delirium may manifest in the immediate post-anesthesia care period. Such episodes appear to be predictive of further episodes of inpatient delirium and associated adverse outcomes. Intraoperative monitoring of frontal electroencephalogram (EEG) has been associated with postoperative delirium and poor outcomes. However, the efficacy of titrating anesthesia medication to proprietary index targets for preventing delirium remains contentious. The investigators aim to assess the efficacy of two pharmacologic strategies which could prevent post-anesthesia care unit (PACU) delirium (1) maximization of intraoperative alpha power during maintenance and (2) switching anesthesia regimes during the emergence phases of anesthesia.

Conditions

Postoperative Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Alpha Optimization

Intervention Type: 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

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Alpha Optimization

Intervention Type: 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-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.

Group Type: ACTIVE_COMPARATOR

Emergence from anesthesia with Dexmedetomidine

Intervention Type: BEHAVIORAL

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Alpha Optimization

Intraoperative oscillatory EEG alpha optimization involves real-time acquisition of oscillatory alpha power from the frontal EEG with individualized titration of sevoflurane and opioid.

Intervention Type: PROCEDURE

Emergence from anesthesia with Dexmedetomidine

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Paul Garcia

Associate Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul S. Garcia, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Irving Medical Center

New York, New York, United States

Countries

United States

Central Contacts

Paul S. Garcia, MD, PhD

Role: CONTACT

pg2618@cumc.columbia.edu

212-304-7678

Tuan Z. Cassim, BA

Role: CONTACT

tc3032@cumc.columbia.edu

917-539-9926

Facility Contacts

Paul S. Garcia, MD, PhD

Role: primary

pg2618@cumc.columbia.edu

212-304-7678

Tuan Z. Cassim, BA

Role: backup

tc3032@cumc.columbia.edu

917-539-9926

Other Identifiers

AAAS4614

Identifier Type: -

Identifier Source: org_study_id