Skip to main content
Clinical Trials/NCT03029676
NCT03029676
Unknown
Phase 4

The Assessment of Postoperative Cognitive Dysfunction After Transurethral Resection of Bladder Tumor Under Spinal Anesthesia

Medical University of Warsaw1 site in 1 country200 target enrollmentJanuary 1, 2017

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2017
End Date
June 30, 2018
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Medical University of Warsaw
Responsible Party
Principal Investigator
Principal Investigator

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)

Study Sites (1)

Loading locations...

Similar Trials