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Preventative Delirium Protocol in Elderly Patients

NCT ID: NCT03541408

Last Updated: 2022-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

263 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-01

Study Completion Date

2021-04-01

Brief Summary

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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

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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).

Conditions

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Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

Subjects will receive anesthesia

Group Type PLACEBO_COMPARATOR

Control

Intervention Type OTHER

Standard Of Care without Preventative Delirium Protocol

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

Group Type EXPERIMENTAL

Preventative Delirium Protocol

Intervention Type OTHER

Preventative Delirium Protocol

Interventions

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Control

Standard Of Care without Preventative Delirium Protocol

Intervention Type OTHER

Preventative Delirium Protocol

Preventative Delirium Protocol

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rush University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Asokumar Buvanendran

Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Asokumar Buvanendran, MD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

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Rush University Medical Center

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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Delirium

Identifier Type: -

Identifier Source: org_study_id

NCT03591120

Identifier Type: -

Identifier Source: nct_alias