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The current study aims to elucidate the effectiveness of a preventative delirium protocol in patients older than 65 years of age undergoing elective surgery.
A comprehensive analysis of patient specific risk factors and predisposing perioperative risk factors will be completed. The objective is to see if delirium incidences are significantly lower in the group that receives a preventative delirium protocol compared to a control group, while not increasing other adverse undesirable side effects. We hypothesize that a preventative delirium protocol will reduce the incidence of delirium compared to the control group (primary outcome), but this protocol may lead to increased side effects such as PONV, poor pain control, and increased awareness (secondary outcomes).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Subjects will receive anesthesia |
|
| Preventative Delirium Protocol | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Other | Standard Of Care without Preventative Delirium Protocol |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Presence or absence of Delirium (CAM_ICU) | Delirium defined by Post-operative CAM, using the validated CAM-ICU measure | Within one post-operative day |
| Measure | Description | Time Frame |
|---|---|---|
| PONV | Post-operative Nausea and Vomiting | Within one post-operative day |
| NRS Pain | Numerical Rating Scale of Pain Intensity, 0 - 10 scale. Value of 0 is No Pain. Value of 10 is Worst Pain Imaginable. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Asokumar Buvanendran, MD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
IPD data to be shared by contacting the primary investigator and executing a data use agreement with Rush University
3 years following publication of study.
Execution of a data use agreement with Rush University
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| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Preventative Delirium Protocol |
| Other |
Preventative Delirium Protocol |
|
| Within one post-operative day |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |