Postoperative Delirium in Patients Undergoing Radical Cystectomy

Not Applicable

Completed

• Conditions: Post-operative Delirium
• Interventions: Behavioral: Assessments; Procedure: Blood Draw; Other: Standardized Anesthetic Care

• Registration Number: NCT03132168
• Lead Sponsor: Ohio State University

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.

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 Timeline

• Study First Submitted: 2017-04-05
• Study First Submitted QC: 2017-04-26
• Study First Posted: 2017-04-27
• Study Start: 2018-01-10
• Primary Completion: 2021-01-31
• Study Completion: 2021-01-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-26
• Last Update Posted: 2021-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects undergoing radical cystectomy	Assessments	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.
Subjects undergoing radical cystectomy	Standardized Anesthetic Care	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.
Subjects undergoing radical cystectomy	Blood Draw	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States