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NCT Number: NCT04443517

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

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.

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Key information

Conditions

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

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Frontal Alpha Power

    Time frame: Up to 24 hours post-surgery

    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.

Secondary outcomes

  1. Incidence of PACU Delirium

    Time frame: Up to 24 hours post-surgery

    3-Minute Diagnostic Interview for Confusion Assessment Method(3D-CAM), Confusion Assessment Method for the ICU (CAM-ICU), Speech / Language Assessment will be administered to check for signs of delirium.

  2. Change in pain in PACU: numerical rating score (NRS)

    Time frame: Up to 24 hours post-surgery

    The numerical rating score (NRS) requires the patient to rate their pain from 0-10 where 0 is no pain and 10 is the worst pain imaginable (high score indicates worse outcome).

Study contacts

Contact information is provided by the study sponsor or research team.

Paul S. Garcia, MD, PhD

CONTACT

[email protected]

212-304-7678

Tuan Z. Cassim, BA

CONTACT

[email protected]

917-539-9926

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Acronym: ALPHA-DEX

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Jun 23, 2020
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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