Clinical trial NCT03132168: Postoperative Delirium in Patients Undergoing Radical Cystectomy
Official title: Postoperative Delirium in Patients Undergoing Radical Cystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-operative Delirium
Keywords: cystectomy
urology
surgery
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2017-04-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Post-operative delirium
timeFrame: up to 3 days post-operatively
Secondary outcomes:
measure: microRNA expression
timeFrame: up to 3 days post-operatively
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Ahmad Shabsigh, MD
role: PRINCIPAL_INVESTIGATOR
References: