Delirium Prevention Protocol in Elderly Patients

Delirium Clinical Trial

Official title:

A Randomized, Controlled Trial Reviewing the Effectiveness of a Preventative Delirium Protocol in Elderly Patients While Analyzing Its Consequential Effects on Awareness, Post-operative Nausea and Vomiting, and/or Pain Control

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03591120
• Other study ID #: DeliriumPreventionProtocol
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2016
• Est. completion date: August 1, 2021

Study information

• Verified date: July 2020
• Source: Rush University Medical Center
• Contact: Robert J McCarthy, PharmD
• Phone: 312-942-7608
• Email: Robert_J_McCarthy[@]rush.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: August 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Delirium

Intervention

Other:
• Control
Standard of Care without Preventative Delirium Protocol
• Preventative Delirium Protocol
Preventative Delirium Protocol

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Bilotta F, Doronzio A, Stazi E, Titi L, Zeppa IO, Cianchi A, Rosa G, Paoloni FP, Bergese S, Asouhidou I, Ioannou P, Abramowicz AE, Spinelli A, Delphin E, Ayrian E, Zelman V, Lumb P. Early postoperative cognitive dysfunction and postoperative delirium after anaesthesia with various hypnotics: study protocol for a randomised controlled trial--the PINOCCHIO trial. Trials. 2011 Jul 6;12:170. doi: 10.1186/1745-6215-12-170. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence or absence of delirium (CAM-ICU)	Delirium defined by Post-operative CAM, using the validated CAM-ICU measure	Within one post-operative day
Secondary	Incidence of Post-operative Nausea and Vomiting	Post-operative Nausea and Vomiting	Within one post-operative day
Secondary	Pain Rating Scale	Numerical Rating Scale of Pain Intensity, 0-10 scale. Value of 0 is No Pain. Value of 10 is Worst Pain Imaginable.	Within one post-operative day