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Preventative Delirium Protocol in Elderly Patients

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Status

Completed

Conditions

Delirium

Treatments

Other: Control
Other: Preventative Delirium Protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT03541408
Delirium

Details and patient eligibility

About

The current study aims to elucidate the effectiveness of a preventative delirium protocol in patients older than 65 years of age undergoing elective surgery.

Full 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).

Enrollment

263 patients

Sex

All

Ages

65 to 89 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

263 participants in 2 patient groups, including a placebo group

Control
Placebo Comparator group
Description:
Subjects will receive anesthesia
Treatment:
Other: Control
Preventative Delirium Protocol
Experimental group
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
Treatment:
Other: Preventative Delirium Protocol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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