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Delirium Prevention Protocol in Elderly Patients

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ClinicalTrials.gov Identifier: NCT03591120
Recruitment Status : Recruiting
First Posted : July 18, 2018
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Robert J McCarthy, Rush University Medical Center

Tracking Information
First Submitted Date  ICMJE July 6, 2018
First Posted Date  ICMJE July 18, 2018
Last Update Posted Date March 26, 2019
Study Start Date  ICMJE May 2016
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03591120 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2018)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Delirium Prevention Protocol in Elderly Patients
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Delirium
Intervention  ICMJE
  • Other: Control
    Standard of Care without Preventative Delirium Protocol
  • Other: Preventative Delirium Protocol
    Preventative Delirium Protocol
Study Arms  ICMJE
  • Placebo Comparator: Control
    Subject will receive anesthesia
    Intervention: Other: Control
  • 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
    Intervention: Other: Preventative Delirium Protocol
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 6, 2018)
340
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2020
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 89 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Robert J McCarthy, PharmD 312-942-7608 Robert_J_McCarthy@rush.edu
Contact: David H Kim, MD 702-588-3470 david_h_kim@rush.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03591120
Other Study ID Numbers  ICMJE DeliriumPreventionProtocol
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Robert J McCarthy, Rush University Medical Center
Study Sponsor  ICMJE Rush University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Asokumar Buvanendran, MD Study Principal Investigator
PRS Account Rush University Medical Center
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP