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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maintenance-Alpha Optimization / Wake from Dexmedetomidine | Experimental | During the first randomization, participants randomized to intraoperative oscillatory EEG alpha optimization will receive individualized titration of anesthetic gas and opioids. |
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| Maintenance-Alpha Optimization / Wake from Sevoflurane | Active Comparator | 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. |
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| Maintenance-Routine Care / Wake from Dexmedetomidine | Active Comparator | 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. |
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| Maintenance-Routine Care / Wake from Sevoflurane | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 24 hours post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 24 hours post-surgery |
| Change in pain in PACU: numerical rating score (NRS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paul S. Garcia, MD, PhD | Contact | 212-304-7678 | pg2618@cumc.columbia.edu | |
| Tuan Z. Cassim, BA | Contact | 917-539-9926 | tc3032@cumc.columbia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Paul S. Garcia, MD, PhD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
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| Emergence from anesthesia with Dexmedetomidine | Behavioral | Infusion of .05 mcg/kg/h of propofol during the final 10-20 minutes of surgery. |
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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). |
| Up to 24 hours post-surgery |
| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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