Preventative Delirium Protocol in Elderly Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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A Randomized, Controlled Trial Reviewing the Effectiveness of a Preventative Delirium Protocol in Elderly Patients While Analyzing Its Consequential Effects on Awareness, PONV, and/or Pain Control

Conditions
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Delirium

Intervention / Treatment
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* Other: Control
* Other: Preventative Delirium Protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 65 years Scheduled for Elective Surgery (outpatient/same-day admit) Exclusion Criteria: Need emergency surgery Need intracranial surgery Dependent on opiate narcotics Surgeon-specified perioperative procedures that precludes the current study's protocol

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Subjects will receive anesthesia | Other: Control<br>* Standard Of Care without Preventative Delirium Protocol<br>|
| Experimental: Preventative Delirium Protocol<br>Consider regional block if applicable Minimized fentanyl usage intraoperatively Intubation + GA adjunct total: 1-2 mcg/kg Sedation: 0-0.25 mcg/kg Post-op: 0.5-1 mcg/kg Avoid morphine Avoid ketamine Avoid diphenhydramine, dexamethasone, scopolamine, metoclopramide, and promethazine Avoid H2-blockers (cimetidine, ranitidine, famotidine) Avoid polypharmacy intraoperatively if possible (i.e. >5 new medications) Fluid repletion based on maintenance and losses | Other: Preventative Delirium Protocol<br>* Preventative Delirium Protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | Within one post-operative day |