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Clinical Trials/NCT03541408
NCT03541408
Completed
Not Applicable

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

Rush University Medical Center1 site in 1 country263 target enrollmentMay 1, 2016
ConditionsDelirium

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Delirium
Sponsor
Rush University Medical Center
Enrollment
263
Locations
1
Primary Endpoint
Presence or absence of Delirium (CAM_ICU)
Status
Completed
Last Updated
3 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
May 1, 2016
End Date
April 1, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Asokumar Buvanendran

Professor of Anesthesiology

Rush University Medical Center

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

Outcomes

Primary Outcomes

Presence or absence of Delirium (CAM_ICU)

Time Frame: Within one post-operative day

Delirium defined by Post-operative CAM, using the validated CAM-ICU measure

Secondary Outcomes

  • NRS Pain(Within one post-operative day)
  • PONV(Within one post-operative day)

Study Sites (1)

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