search
Back to results

Preventative Delirium Protocol in Elderly Patients

Primary Purpose

Delirium

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control
Preventative Delirium Protocol
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium

Eligibility Criteria

65 Years - 89 Years (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Preventative Delirium Protocol

Arm Description

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

Outcomes

Primary Outcome Measures

Presence or absence of Delirium (CAM_ICU)
Delirium defined by Post-operative CAM, using the validated CAM-ICU measure

Secondary Outcome Measures

PONV
Post-operative Nausea and Vomiting
NRS Pain
Numerical Rating Scale of Pain Intensity, 0 - 10 scale. Value of 0 is No Pain. Value of 10 is Worst Pain Imaginable.

Full Information

First Posted
December 7, 2017
Last Updated
December 8, 2022
Sponsor
Rush University Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT03541408
Brief Title
Preventative Delirium Protocol in Elderly Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2016 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
April 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
263 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Subjects will receive anesthesia
Arm Title
Preventative Delirium Protocol
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Standard Of Care without Preventative Delirium Protocol
Intervention Type
Other
Intervention Name(s)
Preventative Delirium Protocol
Intervention Description
Preventative Delirium Protocol
Primary Outcome Measure Information:
Title
Presence or absence of Delirium (CAM_ICU)
Description
Delirium defined by Post-operative CAM, using the validated CAM-ICU measure
Time Frame
Within one post-operative day
Secondary Outcome Measure Information:
Title
PONV
Description
Post-operative Nausea and Vomiting
Time Frame
Within one post-operative day
Title
NRS Pain
Description
Numerical Rating Scale of Pain Intensity, 0 - 10 scale. Value of 0 is No Pain. Value of 10 is Worst Pain Imaginable.
Time Frame
Within one post-operative day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asokumar Buvanendran, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD data to be shared by contacting the primary investigator and executing a data use agreement with Rush University
IPD Sharing Time Frame
3 years following publication of study.
IPD Sharing Access Criteria
Execution of a data use agreement with Rush University

Learn more about this trial

Preventative Delirium Protocol in Elderly Patients

We'll reach out to this number within 24 hrs