Postoperative Delirium
Conditions
Keywords
EEG, General Anesthesia
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.
Interventions
PROCEDUREAlpha 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.
BEHAVIORALEmergence from anesthesia with Dexmedetomidine
Infusion of .05 mcg/kg/h of propofol during the final 10-20 minutes of surgery.
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Frontal Alpha Power | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of PACU Delirium | 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. |
| Change in pain in PACU: numerical rating score (NRS) | 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). |
Countries
United States
Contacts
Primary ContactPaul S. Garcia, MD, PhD
Backup ContactTuan Z. Cassim, BA
Outcome results
None listed