Preventative Delirium Protocol in Elderly Patients

Not Applicable

Completed

• Conditions: Delirium
• Interventions: Other: Preventative Delirium Protocol; Other: Control

• Registration Number: NCT03541408
• Lead Sponsor: Rush University Medical Center

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 Timeline

• Study Start: 2016-05-01
• Study First Submitted: 2017-12-07
• Study First Submitted QC: 2018-05-17
• Study First Posted: 2018-05-30
• Primary Completion: 2021-04-01
• Study Completion: 2021-04-01
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-08
• Last Update Posted: 2022-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 263

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
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
Control	Control	Subjects will receive anesthesia

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
PONV	Within one post-operative day	Post-operative Nausea and Vomiting

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States