Preventative Delirium Protocol in Elderly Patients

Ketamine

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.

Intervention / Treatment

  • Control (OTHER)
    Standard Of Care without Preventative Delirium Protocol
  • Preventative Delirium Protocol (OTHER)

Condition or Disease

  • Delirium

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 65 Years to 89 Years
    Enrollment: 263 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    SINGLE:
    • Participant

    Clinical Trial Dates

    Start date: May 01, 2016 ACTUAL
    Primary Completion: Apr 01, 2021 ACTUAL
    Completion Date: Apr 01, 2021 ACTUAL
    Study First Posted: May 30, 2018 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Dec 08, 2022

    Sponsors / Collaborators

    Lead Sponsor: Rush University Medical Center
    Responsible Party: N/A

    Location

    Chicago, Illinois, USA

    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).

    Participant Groups

    • Subjects will receive anesthesia

    • * 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

    Eligibility Criteria

    Sex: All
    Minimum Age: 65
    Maximum Age: 89
    Age Groups: Older Adult
    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

    Primary Outcomes

    • Delirium defined by Post-operative CAM, using the validated CAM-ICU measure

    Secondary Outcomes

    • Post-operative Nausea and Vomiting

    • Numerical Rating Scale of Pain Intensity, 0 - 10 scale. Value of 0 is No Pain. Value of 10 is Worst Pain Imaginable.

    More Details

    NCT Number: NCT03541408
    Other IDs: Delirium
    Study URL: https://clinicaltrials.gov/study/NCT03541408
    Last updated: Sep 29, 2023