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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorColumbia University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Factorial

Treatments tested in this trial

  • Alpha Optimization

    Procedure/Surgery

    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.

Treatment groups

600 Participants
are divided into 4 treatment groups
Group A: Maintenance-Alpha Optimization / Wake from DexmedetomidineExperimental treatment 2 interventions
Group B: Maintenance-Alpha Optimization / Wake from SevofluraneActive comparator 1 intervention
Group C: Maintenance-Routine Care / Wake from DexmedetomidineActive comparator 1 intervention
Group D: Maintenance-Routine Care / Wake from SevofluraneNo intervention 0 interventions

Trial outcomes

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.

Time frame
Up to 24 hours post-surgery

Secondary outcomes

1

Incidence of PACU Delirium

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.

Time frame
Up to 24 hours post-surgery
2

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

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).

Time frame
Up to 24 hours post-surgery

Other outcomes

Sponsors and contacts

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