The Assessment of Postoperative Cognitive Dysfunction After Transurethral Resection of Bladder Tumor Under Spinal Anesthesia
Overview
- Phase
- Phase 4
- Intervention
- benzodiazepines
- Conditions
- Bladder Tumor
- Sponsor
- Medical University of Warsaw
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- postoperative cognitive disfunction
- Last Updated
- 9 years ago
Overview
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.
Investigators
Karolina Dobrońska
MD
Medical University of Warsaw
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
Arms & Interventions
Group B
spinal anesthesia premedication with benzodiazepine and opioid
Intervention: benzodiazepines
Group B
spinal anesthesia premedication with benzodiazepine and opioid
Intervention: opioid
Group B
spinal anesthesia premedication with benzodiazepine and opioid
Intervention: spinal anesthesia
Group K
spinal anesthesia premedication with opioid
Intervention: opioid
Group K
spinal anesthesia premedication with opioid
Intervention: spinal anesthesia
Outcomes
Primary Outcomes
postoperative cognitive disfunction
Time Frame: 6 months
evaluated by Montreal Cognitive Assesment
Secondary Outcomes
- the influence of benzodiazepines on POCD(6 months)