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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT03029676
Date of registration: 20/01/2017
Prospective Registration: No
Primary sponsor: Medical University of Warsaw
Public title: The Assessment of POCD After TURBT Under Spinal Anesthesia
Scientific title: The Assessment of Postoperative Cognitive Dysfunction After Transurethral Resection of Bladder Tumor Under Spinal Anesthesia
Date of first enrolment: January 1, 2017
Target sample size: 200
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03029676
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).  
Phase:  Phase 4
Countries of recruitment
Poland
Contacts
Name:     Karolina Dobronska, MD
Address: 
Telephone: +48 22 501 17 27
Email: karolinapladzyk@gmail.com
Affiliation: 
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Postoperative Cognitive Dysfunction
Bladder Tumor
Intervention(s)
Procedure: spinal anesthesia
Drug: opioid
Drug: benzodiazepines
Primary Outcome(s)
postoperative cognitive disfunction [Time Frame: 6 months]
Secondary Outcome(s)
the influence of benzodiazepines on POCD [Time Frame: 6 months]
Secondary ID(s)
U/1/2017
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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