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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 263
- Locations
- 1
- Primary Endpoint
- Presence or absence of Delirium (CAM_ICU)
Study Overview
Brief Summary
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
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 65 Years to 89 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Control
Subjects will receive anesthesia
Intervention: Control (Other)
Preventative Delirium Protocol
-
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
Intervention: Preventative Delirium Protocol (Other)
Outcomes
Primary Outcomes
Presence or absence of Delirium (CAM_ICU)
Time Frame: Within one post-operative day
Delirium defined by Post-operative CAM, using the validated CAM-ICU measure
Secondary Outcomes
- NRS Pain(Within one post-operative day)
- PONV(Within one post-operative day)
Investigators
Asokumar Buvanendran
Professor of Anesthesiology
Rush University Medical Center