Delirium Prevention Protocol in Elderly Patients

Overview

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

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 1, 2020

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

  • Other: Control
    • Standard of Care without Preventative Delirium Protocol
  • Other: Preventative Delirium Protocol
    • Preventative Delirium Protocol

Arms, Groups and Cohorts

  • Placebo Comparator: Control
    • Subject will receive anesthesia
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: 89 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Rush University Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Robert J McCarthy, Research Director – Rush University Medical Center
  • Overall Official(s)
    • Asokumar Buvanendran, MD, Principal Investigator, Study Principal Investigator
  • Overall Contact(s)
    • Robert J McCarthy, PharmD, 312-942-7608, Robert_J_McCarthy@rush.edu

References

Bilotta F, Doronzio A, Stazi E, Titi L, Zeppa IO, Cianchi A, Rosa G, Paoloni FP, Bergese S, Asouhidou I, Ioannou P, Abramowicz AE, Spinelli A, Delphin E, Ayrian E, Zelman V, Lumb P. Early postoperative cognitive dysfunction and postoperative delirium after anaesthesia with various hypnotics: study protocol for a randomised controlled trial–the PINOCCHIO trial. Trials. 2011 Jul 6;12:170. doi: 10.1186/1745-6215-12-170.

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