Spinal AnaesthesiaNCT03221829
A Retrospective Analysis of Spinal Anaesthesia for TURBT Procedures in Elderly Patients
An observational study of Spinal Anaesthesia and Bladder Tumor, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The aim of the study was to evaluate the safety and effectiveness of spinal anesthesia among elderly patients The basic methods for diagnosis and management of bladder cancer include endoscopic procedures (cystoscopy, trans-urethral resection of bladder tumour TURBT). Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Anaesthesia, Bladder Tumor, Transurethral Resection
- How many people
- 2,800 participants
- Where
- 1 sitePoland
- Study dates
- 6 Jul 2017to 31 Dec 2017
- Phase
- Observational
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients that have TURBT procedure under spinal anaesthesia in the Urology Departament (Medical University of Warsaw) 2007-2017
Who may be able to join
- TURBT procedure
- spinal anaesthesia
- age over 60
Who cannot join
- general anaesthesia
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: A Retrospective Analysis of Spinal Anaesthesia for Transurethral Resection of Bladder Tumour in Elderly Patients: A Single Centre Experience From 2007 to 2017
The aim of the study was to evaluate the safety and effectiveness of spinal anesthesia among elderly patients The basic methods for diagnosis and management of bladder cancer include endoscopic procedures (cystoscopy, trans-urethral resection of bladder tumour TURBT). The age of most patients is above 60, which increases the risk of complications during the perioperative period. Usually the leading anaesthesia method in TURBT procedures is regional, mainly spinal, anaesthesia. Although the prevalence of regional upon general anaesthesia is questioned, certain positive aspects of regional anaesthesia are indisputable. Maintaining logical communication with a patient during the procedure enables early diagnosis of complications (TUR syndrome, bladder perforation). Undeniably, regional anaesthesia ensures the best pain management in the early post-operative period. The simplicity of performing an efficacious spinal block and its cost-effectiveness are additional factors, which have contributed to the acknowledgement of the method as the standard of anaesthesia for transurethral procedures.
- Conditions
- Spinal Anaesthesia, Bladder Tumor, Transurethral Resection
- Keywords
- spinal anaesthesia, elderly patients, transurethral resection of bladder tumour
- Medical subject headings
- Urinary Bladder Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The effectiveness of spinal anaesthesia for TURBT evaluated by a number of participants that had the procedure done, without the need of conversion to general anaesthesia .
The investigator evaluates whether the procedure could be completely performed under spinal anesthesia
Measured: 6 months
Secondary outcomes (4)
The influence of the bupivacaine spinal dose on bradycardia evaluated by a heart rate measurements
The investigator evaluates the bupivacaine doses, heart rate and the need to give atropine
Measured: 6 months
The influence of the bupivacaine dose on hypotension evaluated by the non-invasive blood pressure measurements
The investigator evaluates the bupivacaine doses, blood pressure and the need to give ephedrine
Measured: 6 months
Experienced and non-experienced anesthetist does it influence the bupivacaine dose
The investigator evaluates the doses of bupivacaine spinal given by specialist, young and advanced trainee.
Measured: 6 months
Experienced and non-experienced anesthetist does it influence the spinal anaesthesia success
The investigator evaluates the success rate of spinal anaesthesia given by specialist, young and advanced trainee.
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 posted19 Jul 2017
- Study start6 Jul 2017
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnaesthesiaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 2,800 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
- NCT03221829
- Sponsor's protocol ID
- U/2/2017
- Status last verified
- Jul 2017
- First submitted
- 13 Jul 2017
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Analysis of Spinal Anaesthesia for Transurethral Resection of Bladder Tumour in Elderly Patients: A Single Centre Experience From 2007 to 2017
- ClinicalTrials.gov ID
- NCT03221829
- Acronym / sponsor ID
- U/2/2017
- Conditions
- Spinal Anaesthesia, Bladder Tumor, Transurethral Resection
- Keywords
- spinal anaesthesia, elderly patients, transurethral resection of bladder tumour
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,800 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 6 Jul 2017 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 19 Jul 2017 (actual)
- 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.
The aim of the study was to evaluate the safety and effectiveness of spinal anesthesia among elderly patients The basic methods for diagnosis and management of bladder cancer include endoscopic procedures (cystoscopy, trans-urethral resection of bladder tumour TURBT). The age of most patients is above 60, which increases the risk of complications during the perioperative period. Usually the leading anaesthesia method in TURBT procedures is regional, mainly spinal, anaesthesia. Although the prevalence of regional upon general anaesthesia is questioned, certain positive aspects of regional anaesthesia are indisputable. Maintaining logical communication with a patient during the procedure enables early diagnosis of complications (TUR syndrome, bladder perforation). Undeniably, regional anaesthesia ensures the best pain management in the early post-operative period. The simplicity of performing an efficacious spinal block and its cost-effectiveness are additional factors, which have contributed to the acknowledgement of the method as the standard of anaesthesia for transurethral procedures.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients that have TURBT procedure under spinal anaesthesia in the Urology Departament (Medical University of Warsaw) 2007-2017
Key inclusion criteria (3 listed)
- TURBT procedure
- spinal anaesthesia
- age over 60
Key exclusion criteria (1 listed)
- general anaesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The effectiveness of spinal anaesthesia for TURBT evaluated by a number of participants that had the procedure done, without the need of conversion to general anaesthesia .
Time frame: 6 months
The investigator evaluates whether the procedure could be completely performed under spinal anesthesia
4 secondary outcomes
The influence of the bupivacaine spinal dose on bradycardia evaluated by a heart rate measurements
Time frame: 6 months
The influence of the bupivacaine dose on hypotension evaluated by the non-invasive blood pressure measurements
Time frame: 6 months
Experienced and non-experienced anesthetist does it influence the bupivacaine dose
Time frame: 6 months
Experienced and non-experienced anesthetist does it influence the spinal anaesthesia success
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 19 Jul 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Anaesthesia and Bladder Tumor, 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 1 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 19 Jul 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.
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?
Contact Karolina Dobronska, MD, PhD (48 501 323 534, karolinadobronska@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effectiveness of spinal anaesthesia for TURBT evaluated by a number of participants that had the procedure done, without the need of conversion to general anaesthesia . (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 19 Jul 2017.