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

Columbia University

Status: Begins enrollment in 1 month

Conditions: Postoperative Delirium

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04443517

AAAS4614

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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600 participants in 4 patient groups

Maintenance-Alpha Optimization / Wake from Dexmedetomidine

Experimental group

Description:

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

Treatment:

Procedure: Alpha Optimization

Behavioral: Emergence from anesthesia with Dexmedetomidine

Maintenance-Alpha Optimization / Wake from Sevoflurane

Active Comparator group

Description:

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.

Treatment:

Procedure: Alpha Optimization

Maintenance-Routine Care / Wake from Dexmedetomidine

Active Comparator group

Description:

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.

Treatment:

Behavioral: Emergence from anesthesia with Dexmedetomidine

Maintenance-Routine Care / Wake from Sevoflurane

No Intervention group

Description:

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.