Postoperative Delirium in Patients Undergoing Radical Cystectomy

NCT03132168 | Completed

• 1 other identifier: 2016H0021
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, post-operative delirium will be measured in patients undergoing surgery for bladder resection, and associated microRNA biomarkers will be evaluated in patients considered delirious and non-delirious after surgery.

Conditions

Post-operative Delirium

Keywords

cystectomy; urology; surgery

Outcome Measures

Primary Outcomes (1)

• Post-operative delirium

  Evaluate the incidence of and risk factors for POD in patients undergoing radical cystectomy utilizing the Memorial Delirium Assessment Scale.

  up to 3 days post-operatively

Secondary Outcomes (1)

• microRNA expression

  up to 3 days post-operatively

Study Arms (1)

Subjects undergoing radical cystectomy

OTHER

Subjects involved in the study will be evaluated with various non-invasive assessments including the Richmond Agitation-Sedation Scale, pain assessments on a Numeric Rating Scale (NRS-11), and CAM-ICU scale. Blood draws will also take place in order to perform microRNA testing in all subjects participating in the trial. Standardized anesthetic care as described by the approved protocol will be followed for each subject included in this trial.

Behavioral: Assessments; Procedure: Blood Draw; Other: Standardized Anesthetic Care

Interventions

Assessments BEHAVIORAL

These cognitive assessments will be utilized during the study to evaluate cognitive levels comparing prior to surgery and post-operatively in order to determine if the subject is delirious. BIS monitoring will be utilized for all subjects.

Also known as: SAGE scale, Memorial Delirium Assessment Scale

Subjects undergoing radical cystectomy

Blood Draw PROCEDURE

Subjects will have blood draws at surgical preadmission visit, Day 1, Day 2, and Day 3 post surgery only; one tube containing approximately one teaspoon (5 mL) of blood will be drawn at each visit.

Subjects undergoing radical cystectomy

Standardized Anesthetic Care OTHER

Standardized anesthetic care will be provided as described by the protocol for each subject consented for this trial.

Also known as: Anesthetic Regimen

Subjects undergoing radical cystectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18 years of age and older
• ASA II or III
• Capable of and willing to consent
• Participants literate in English language

You may not qualify if:

• ASA IV or V
• Patients with severe visual or auditory impairment
• Inability to read and/or write in English
• Presence of a clinically diagnosed major psychiatric condition such as bipolar disorder, uncontrolled major depression, schizophrenia
• Dementia of Alzheimer's type
• Parkinson's disease
• Multiple Sclerosis (MS)
• Vascular dementia

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ahmad Shabsigh, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: All consented subjects will be undergoing elective, scheduled surgeries with standardized anesthesia regimen per protocol. Each participant will complete surveys and procedures as outlined per protocol.

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 27, 2017
• Study Start: January 10, 2018
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: August 27, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)