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Preventative Delirium Protocol in Elderly Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03541408
Recruitment Status : Completed
First Posted : May 30, 2018
Last Update Posted : August 27, 2021
Sponsor:
Information provided by (Responsible Party):
Asokumar Buvanendran, Rush University Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Delirium Other: Control Other: Preventative Delirium Protocol Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official 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
Actual Study Start Date : May 1, 2016
Actual Primary Completion Date : April 1, 2021
Actual Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   65 Years to 89 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03541408


Locations
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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Investigators
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Principal Investigator: Asokumar Buvanendran, MD Rush University Medical Center
More Information
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Responsible Party: Asokumar Buvanendran, Professor of Anesthesiology, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT03541408    
Obsolete Identifiers: NCT03591120
Other Study ID Numbers: Delirium
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: August 27, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
 Nervous System Diseases
Neurocognitive Disorders
Mental Disorders