Postoperative Delirium in Patients Undergoing Radical Cystectomy
Keywords
Abstract
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.
Dates
| Last Verified: | 03/31/2017 |
| First Submitted: | 04/04/2017 |
| Estimated Enrollment Submitted: | 04/25/2017 |
| First Posted: | 04/26/2017 |
| Last Update Submitted: | 04/25/2017 |
| Last Update Posted: | 04/26/2017 |
| Actual Study Start Date: | 07/31/2016 |
| Estimated Primary Completion Date: | 12/31/2017 |
| Estimated Study Completion Date: | 12/31/2017 |
Condition or disease
Intervention/treatment
Behavioral: Subjects undergoing radical cystectomy
Procedure: Subjects undergoing radical cystectomy
Other: Subjects undergoing radical cystectomy
Phase
Arm Groups
| 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: Subjects undergoing radical cystectomy 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. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. Post-operative delirium [up to 3 days post-operatively]
Secondary Outcome Measures
1. microRNA expression [up to 3 days post-operatively]
