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Delirium Prevention 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03591120
Recruitment Status : Recruiting
First Posted : July 18, 2018
Last Update Posted : March 26, 2019
Information provided by (Responsible Party):
Robert J McCarthy, Rush University Medical Center

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 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, Post-operative Nausea and Vomiting, and/or Pain Control
Study Start Date : May 2016
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Control
Subject 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 + general anesthesia adjunct total: 1-2 mcg/kg fentanyl
  • Sedation: 0-0.24 mcg/kg fentanyl
  • Post-operative: 0.5 - 1 mcg/kg fentanyl
  • 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

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. Incidence of Post-operative Nausea and Vomiting [ Time Frame: Within one post-operative day ]
    Post-operative Nausea and Vomiting

  2. Pain Rating Scale [ 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 89 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts 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

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 identifier (NCT number): NCT03591120

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Contact: Robert J McCarthy, PharmD 312-942-7608
Contact: David H Kim, MD 702-588-3470

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United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Robert J McCarthy, PharmD    312-942-7608   
Contact: David H Kim, MD    702-588-3470   
Sponsors and Collaborators
Rush University Medical Center
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Principal Investigator: Asokumar Buvanendran, MD Study Principal Investigator

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Responsible Party: Robert J McCarthy, Research Director, Rush University Medical Center Identifier: NCT03591120     History of Changes
Other Study ID Numbers: DeliriumPreventionProtocol
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: July 2018
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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Postoperative Nausea and Vomiting
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Postoperative Complications
Pathologic Processes
Signs and Symptoms, Digestive