Preventative Delirium Protocol in Elderly Patients
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
1 other identifier
interventional
263
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 7, 2017
CompletedFirst Posted
Study publicly available on registry
May 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedDecember 12, 2022
December 1, 2022
4.9 years
December 7, 2017
December 8, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
PONV
Within one post-operative day
NRS Pain
Within one post-operative day
Study Arms (2)
Control
PLACEBO COMPARATORSubjects will receive anesthesia
Preventative Delirium Protocol
EXPERIMENTAL* 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
Interventions
Eligibility Criteria
You may qualify if:
- Age \> 65 years
- Scheduled for Elective Surgery (outpatient/same-day admit)
You may not qualify if:
- Need emergency surgery
- Need intracranial surgery
- Dependent on opiate narcotics
- Surgeon-specified perioperative procedures that precludes the current study's protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rush University Medical Center
Chicago, Illinois, 60612, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Asokumar Buvanendran, MD
Rush University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Anesthesiology
Study Record Dates
First Submitted
December 7, 2017
First Posted
May 30, 2018
Study Start
May 1, 2016
Primary Completion
April 1, 2021
Study Completion
April 1, 2021
Last Updated
December 12, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- 3 years following publication of study.
- Access Criteria
- Execution of a data use agreement with Rush University
IPD data to be shared by contacting the primary investigator and executing a data use agreement with Rush University