Bladder TumorPhase 4NCT03029676
The Assessment of POCD After TURBT Under Spinal Anesthesia
A Phase 4 study testing benzodiazepines, opioid and spinal anesthesia in people with Bladder Tumor and Postoperative Cognitive Dysfunction, run by Medical University of Warsaw at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Tumor, Postoperative Cognitive Dysfunction
- What is being tested?
- benzodiazepines, opioid and spinal anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2017to 30 Jun 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- informed consent
- transurethral resection of the bladder tumor
- spinal anesthesia
Who cannot join
- patients' refusal
- contraindications for spinal anesthesia
- skin lesions at injection site
- depression
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
I Department of Anaesthesiology and Intensive Care, Medical University of Warsaw
Warsaw, 02-005
Karolina Dobronska, MD, +48 22 501 17 27, karolinapladzyk@gmail.com
Lidia I Jureczko, PhD MD, +48 22 501 17 27, jureczko@gmail.com
About this study
Official title: The Assessment of Postoperative Cognitive Dysfunction After Transurethral Resection of Bladder Tumor Under Spinal Anesthesia
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.
Read the 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.
- Conditions
- Bladder Tumor, Postoperative Cognitive Dysfunction
- Being tested
- benzodiazepines, opioid, spinal anesthesia
- Keywords
- spinal anesthesia, TURBT, POCD, premedication
- Medical subject headings
- Urinary Bladder Neoplasms, Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
benzodiazepinesDrug
Also called midazolam
sedative
opioidDrug
Also called fentanyl
analgetic, sedative
spinal anesthesiaProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group B | Experimental | spinal anesthesia premedication with benzodiazepine and opioid Receives: Drug: benzodiazepines; Drug: opioid; Procedure: spinal anesthesia |
| Group K | Active comparator | spinal anesthesia premedication with opioid Receives: Drug: opioid; Procedure: spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative cognitive disfunction
evaluated by Montreal Cognitive Assesment
Measured: 6 months
Secondary outcomes (1)
the influence of benzodiazepines on POCD
evaluated by Montreal Cognitive Assesment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study start1 Jan 2017
- Primary completion31 Dec 2017 (estimated)
- Study completion30 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder TumorStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karolina Dobrońska, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029676
- Sponsor's protocol ID
- U/1/2017
- Status last verified
- Jan 2017
- First submitted
- 20 Jan 2017
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of Postoperative Cognitive Dysfunction After Transurethral Resection of Bladder Tumor Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT03029676
- Acronym / sponsor ID
- U/1/2017
- Conditions
- Bladder Tumor, Postoperative Cognitive Dysfunction
- Keywords
- spinal anesthesia, TURBT, POCD, premedication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 24 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group B | Experimental | Drug: benzodiazepines, Drug: opioid, Procedure: spinal anesthesiaspinal anesthesia premedication with benzodiazepine and opioid |
| Group K | Active comparator | Drug: opioid, Procedure: spinal anesthesiaspinal anesthesia premedication with opioid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- informed consent
- transurethral resection of the bladder tumor
- spinal anesthesia
Key exclusion criteria (4 listed)
- patients' refusal
- contraindications for spinal anesthesia
- skin lesions at injection site
- depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| benzodiazepinesAlso: midazolamsedative | Drug | Group B |
| opioidAlso: fentanylanalgetic, sedative | Drug | Group B, Group K |
| spinal anesthesia | Procedure or surgery | Group B, Group K |
Primary outcome
postoperative cognitive disfunction
Time frame: 6 months
evaluated by Montreal Cognitive Assesment
1 secondary outcome
the influence of benzodiazepines on POCD
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
I Department of Anaesthesiology and Intensive Care, Medical University of Warsaw
Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing benzodiazepines, opioid and spinal anesthesia in people with Bladder Tumor and Postoperative Cognitive Dysfunction, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative cognitive disfunction (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2017.