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Completed

NCT Number: NCT03541408

Preventative Delirium Protocol in Elderly Patients

The current study aims to elucidate the effectiveness of a preventative delirium protocol in patients older than 65 years of age undergoing elective surgery.

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Key information

Conditions

Delirium Confusion Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

Other

Standard Of Care without Preventative Delirium Protocol

Preventative Delirium Protocol

Other

Preventative Delirium Protocol

Primary outcomes

  1. 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

  1. PONV

    Time frame: Within one post-operative day

    Post-operative Nausea and Vomiting

  2. NRS Pain

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
May 30, 2018
Registry last updated
Dec 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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