The Assessment of POCD After TURBT Under Spinal Anesthesia
Primary Purpose
Bladder Tumor, Postoperative Cognitive Dysfunction
Status
Unknown status
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
benzodiazepines
opioid
spinal anesthesia
Sponsored by
About this trial
This is an interventional treatment trial for Bladder Tumor focused on measuring spinal anesthesia, TURBT, POCD, premedication
Eligibility Criteria
Inclusion Criteria:
- informed consent
- transurethral resection of the bladder tumor
- spinal anesthesia
Exclusion Criteria:
Exclusion Criteria:
- patients' refusal
- contraindications for spinal anesthesia
- skin lesions at injection site
- depression
Sites / Locations
- I Department of Anaesthesiology and Intensive Care, Medical University of WarsawRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group B
Group K
Arm Description
spinal anesthesia premedication with benzodiazepine and opioid
spinal anesthesia premedication with opioid
Outcomes
Primary Outcome Measures
postoperative cognitive disfunction
evaluated by Montreal Cognitive Assesment
Secondary Outcome Measures
the influence of benzodiazepines on POCD
evaluated by Montreal Cognitive Assesment
Full Information
NCT ID
NCT03029676
First Posted
January 20, 2017
Last Updated
January 20, 2017
Sponsor
Medical University of Warsaw
1. Study Identification
Unique Protocol Identification Number
NCT03029676
Brief Title
The Assessment of POCD After TURBT Under Spinal Anesthesia
Official Title
The Assessment of Postoperative Cognitive Dysfunction After Transurethral Resection of Bladder Tumor Under Spinal Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Anticipated)
Study Completion Date
June 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Warsaw
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the influence of premedication on cognitive functions in patients undergoing transurethral resection of bladder tumor under spinal anesthesia. The aims of premedication are anxiolysis, analgesia and the reduction of perioperative risk among the patients with comorbidities. The patients will be randomly allocated to receive premedication either with opioid solely or with benzodiazepine combined with opioid. The anesthetic technique is standardized.
Detailed Description
Trans-urethral resection of bladder tumor (TURBT) is the basic endoscopic procedure for management of bladder cancer and if there are no contraindications, it is performed under spinal anesthesia. The condition usually occurs among elderly patients, every 9 of 10 is older than 55 years. At this age the postoperative cognitive dysfunction (POCD) is a common complication as the risk increases with age. There are some studies indicating that using benzodiazepines during the perioperative period can also increase the number of registered POCD in patients undergoing anesthesia. Postoperative cognitive dysfunction (POCD) occurs after operations under regional and general anesthesia as well. The study was planed to evaluate the risk of POCD among urological patients and to asses whether combining benzodiazepines with opioids for premedication increases this risk.
The participants after giving the informed consent can participate in the study. The Beck Depression Inventory is performed to rule out the patients with depression. The cognitive functions are tested with Montreal Cognitive Assessment before the surgery and subsequently in the first 24 hours after surgery, three weeks later (while patients come back to receive histopathological examination), and finally six months after surgery (during control cystoscopy).
During anesthesia, the patients will be randomly allocated to receive premedication either with opioid solely or with benzodiazepine combined with opioid. The anesthetic technique is standardized. If the premedication is needed before the surgery the hydroxyzine will be administrated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Tumor, Postoperative Cognitive Dysfunction
Keywords
spinal anesthesia, TURBT, POCD, premedication
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
the participant is not performed about the type of premedication performed
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group B
Arm Type
Experimental
Arm Description
spinal anesthesia premedication with benzodiazepine and opioid
Arm Title
Group K
Arm Type
Active Comparator
Arm Description
spinal anesthesia premedication with opioid
Intervention Type
Drug
Intervention Name(s)
benzodiazepines
Other Intervention Name(s)
midazolam
Intervention Description
sedative
Intervention Type
Drug
Intervention Name(s)
opioid
Other Intervention Name(s)
fentanyl
Intervention Description
analgetic, sedative
Intervention Type
Procedure
Intervention Name(s)
spinal anesthesia
Primary Outcome Measure Information:
Title
postoperative cognitive disfunction
Description
evaluated by Montreal Cognitive Assesment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
the influence of benzodiazepines on POCD
Description
evaluated by Montreal Cognitive Assesment
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
informed consent
transurethral resection of the bladder tumor
spinal anesthesia
Exclusion Criteria:
Exclusion Criteria:
patients' refusal
contraindications for spinal anesthesia
skin lesions at injection site
depression
Facility Information:
Facility Name
I Department of Anaesthesiology and Intensive Care, Medical University of Warsaw
City
Warsaw
ZIP/Postal Code
02-005
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karolina Dobronska, MD
Phone
+48 22 501 17 27
Email
karolinapladzyk@gmail.com
First Name & Middle Initial & Last Name & Degree
Lidia I Jureczko, PhD MD
Phone
+48 22 501 17 27
Email
jureczko@gmail.com
First Name & Middle Initial & Last Name & Degree
Karolina Dobronska, MD
First Name & Middle Initial & Last Name & Degree
Lidia I Jureczko, PhD MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Assessment of POCD After TURBT Under Spinal Anesthesia
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