Postoperative Delirium in Patients Undergoing Radical Cystectomy

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.

Study Overview

• Status: Completed
• Conditions: Post-operative Delirium
• Intervention / Treatment: Behavioral: Assessments; Procedure: Blood Draw; Other: Standardized Anesthetic Care

Detailed Description

With voluntary participation, this study requires participants to complete a self-administered cognitive evaluation (SAGE) before surgery to assess baseline cognitive impairment and early dementia; vital signs will be documented prior to surgery. During surgery, participants will receive a standardized general anesthesia regimen as described in the protocol. Several parameters will be measured during surgery, including bispectral monitoring to measure processed EEG. After surgery, fitness for cognitive evaluation will be determined by the Richmond Agitation-Sedation Scale (RASS) scale, and then emergence delirium will be assessed using the CAM-ICU scale. Fitness for discharge from PACU will be determined by an Aldrete score of 9 or more. Postoperative pain will be assessed using the 11-point Numeric Rating Scale (NRS-11). Postoperative nausea and vomiting (PONV) level will also be documented. Postoperative Delirium (POD) assessment will be achieved by administering the memorial delirium assessment scale (MDAS) twice a day starting on day 1 through day 3 postoperatively. Pain NRS-11 score and PONV levels will also be documented at each visit. For microRNA testing, blood probes will be collected in 5mL purple top tube at surgical preadmission and post-surgery days one, two and three. Risks associated with participating in this study include normal risk associated with having surgery and general anesthesia; no greater than minimal risk is associated with blood collection. For the participant, there are no immediate anticipated benefits for participating in this study. The importance of the knowledge that is expected to result includes lower post-operative complications as a result of post-operative delirium, faster recovery, and shorter hospital stay.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: Subjects undergoing radical cystectomy; 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; 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.; Other Names: SAGE scale, Memorial Delirium Assessment Scale; Procedure: Blood Draw; 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.; Other: Standardized Anesthetic Care; Standardized anesthetic care will be provided as described by the protocol for each subject consented for this trial.; Other Names: Anesthetic Regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
microRNA expression	A secondary aim of the study is to obtain estimates and variances of the difference in microRNA expression between 2 groups: delirious patients and non-delirious patients.	up to 3 days post-operatively

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Ahmad Shabsigh, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 10, 2018
• Primary Completion (ACTUAL): January 31, 2021
• Study Completion (ACTUAL): January 31, 2021

Study Registration Dates

• First Submitted: April 5, 2017
• First Submitted That Met QC Criteria: April 26, 2017
• First Posted (ACTUAL): April 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 27, 2021
• Last Update Submitted That Met QC Criteria: August 26, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: surgery; cystectomy; urology
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 2016H0021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No