Postoperative Delirium in Patients Undergoing Radical Cystectomy

Sponsor

Ohio State University (Other)

Overall Status

Completed

CT.gov ID

NCT03132168

Collaborator

(none)

Enrollment

Location

Arm

36.7

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post-operative Delirium	Behavioral: Assessments Procedure: Blood Draw Other: Standardized Anesthetic Care	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Masking Description:

No masking

Primary Purpose:

Other

Official Title:

Postoperative Delirium in Patients Undergoing Radical Cystectomy

Actual Study Start Date :

Jan 10, 2018

Actual Primary Completion Date :

Jan 31, 2021

Actual Study Completion Date :

Jan 31, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Post-operative delirium [up to 3 days post-operatively]
Evaluate the incidence of and risk factors for POD in patients undergoing radical cystectomy utilizing the Memorial Delirium Assessment Scale.

Secondary Outcome Measures

microRNA expression [up to 3 days post-operatively]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State University Wexner Medical Center	Columbus	Ohio	United States	43210

Sponsors and Collaborators

Ohio State University

Investigators

Principal Investigator: Ahmad Shabsigh, MD, Ohio State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmad Shabsigh, Assistant Professor, Ohio State University

ClinicalTrials.gov Identifier:

NCT03132168

Other Study ID Numbers:

2016H0021

First Posted:

Apr 27, 2017

Last Update Posted:

Aug 27, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ahmad Shabsigh, Assistant Professor, Ohio State University

cystectomy

urology

surgery

Additional relevant MeSH terms:

Delirium

Anesthetics

Study Results

No Results Posted as of Aug 27, 2021