Preventative Delirium Protocol in Elderly Patients

Sponsor

Rush University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT03541408

Collaborator

(none)

240

Enrollment

Location

Arms

Actual Duration (Months)

4.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Delirium	Other: Control Other: Preventative Delirium Protocol	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

240 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, PONV, and/or Pain Control

Actual Study Start Date :

May 1, 2016

Actual Primary Completion Date :

Apr 1, 2021

Actual Study Completion Date :

Apr 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control Subjects 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 + 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	Other: Preventative Delirium Protocol Preventative Delirium Protocol

Arm

Intervention/Treatment

Placebo Comparator: Control

Subjects 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 + 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

Other: Preventative Delirium Protocol

Preventative Delirium Protocol

Outcome Measures

Primary Outcome Measures

Presence or absence of Delirium (CAM_ICU) [Within one post-operative day]
Delirium defined by Post-operative CAM, using the validated CAM-ICU measure

Secondary Outcome Measures

PONV [Within one post-operative day]
Post-operative Nausea and Vomiting
NRS Pain [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 89 Years

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rush University Medical Center	Chicago	Illinois	United States	60612

Sponsors and Collaborators

Rush University Medical Center

Investigators

Principal Investigator: Asokumar Buvanendran, MD, Rush University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Asokumar Buvanendran, Professor of Anesthesiology, Rush University Medical Center

ClinicalTrials.gov Identifier:

NCT03541408

Other Study ID Numbers:

Delirium
NCT03591120

First Posted:

May 30, 2018

Last Update Posted:

Aug 27, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Delirium

Study Results

No Results Posted as of Aug 27, 2021