Preventative Delirium Protocol in Elderly Patients

December 8, 2022 updated by: Asokumar Buvanendran, Rush University Medical Center

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

263

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 89 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Subjects will receive anesthesia
Other: Control
Standard Of Care without Preventative Delirium Protocol
Experimental: 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
Other: Preventative Delirium Protocol
Preventative Delirium Protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within one post-operative day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PONV
Time Frame: Within one post-operative day
Post-operative Nausea and Vomiting
Within one post-operative day
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.
Within one post-operative day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rush University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

April 1, 2021

Study Completion (Actual)

April 1, 2021

Study Registration Dates

First Submitted

December 7, 2017

First Submitted That Met QC Criteria

May 17, 2018

First Posted (Actual)

May 30, 2018

Study Record Updates

Last Update Posted (Estimate)

December 12, 2022

Last Update Submitted That Met QC Criteria

December 8, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Delirium

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

IPD data to be shared by contacting the primary investigator and executing a data use agreement with Rush University

IPD Sharing Time Frame

3 years following publication of study.

IPD Sharing Access Criteria

Execution of a data use agreement with Rush University

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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