Postoperative Delirium in Patients Undergoing Radical Cystectomy
Status: | Recruiting |
---|---|
Conditions: | Hospital, Psychiatric |
Therapuetic Areas: | Psychiatry / Psychology, Other |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/28/2017 |
Start Date: | August 2016 |
End Date: | January 2018 |
Contact: | Ahmad Shabsigh, MD |
Email: | ahmad.shabsigh@osumc.edu |
Phone: | (614) 685-4263 |
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.
bladder resection, and associated microRNA biomarkers will be evaluated in patients
considered delirious and non-delirious after surgery.
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.
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.
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
We found this trial at
1
site
410 W 10th Ave
Columbus, Ohio 43210
Columbus, Ohio 43210
(614) 293-8652
Phone: 614-685-4263
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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