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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03541408

Enrollment

263

Registered

2018-05-30

Start date

2016-05-01

Completion date

2021-04-01

Last updated

2022-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

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).

Interventions

OTHERControl

Standard Of Care without Preventative Delirium Protocol

OTHERPreventative Delirium Protocol

Preventative Delirium Protocol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

65 Years to 89 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Presence or absence of Delirium (CAM_ICU)	Within one post-operative day	Delirium defined by Post-operative CAM, using the validated CAM-ICU measure

Secondary

Measure	Time frame	Description
PONV	Within one post-operative day	Post-operative Nausea and Vomiting
NRS Pain	Within one post-operative day	Numerical Rating Scale of Pain Intensity, 0 - 10 scale. Value of 0 is No Pain. Value of 10 is Worst Pain Imaginable.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026