Bladder CancerNCT05824299
Influence of Anesthesia Methods on CTCs in TURBT Patients
A study testing General Anesthesia and Spinal Anesthesia in people with Bladder Cancer, run by RenJi Hospital at 1 site in China.
Trial summary
Multiple lines of evidence have shown that anesthesia method is associated with long-term outcomes in patients undergoing surgery due to cancers, including lung, breast, prostate, and bladder cancer, etc. Circulating tumor cells (CTCs) have been validated as prognostic biomarkers of a number of cancers. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- General Anesthesia and Spinal Anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2023to 30 Jun 2024
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- .≤18 Age ≤85，ASAI-III.
- .Patients with primary bladder cancer of Stage T1 to T4, who are scheduled for transurethral resection of bladder tumor.
- .Written informed consent.
Who cannot join
- History of surgery within 6 months.
- Contraindications for spinal anesthesia.
- With a history of any other malignancy.
- Having received preoperative neoadjuvant therapy.
- History of long-term opioid use.
- Combined with autoimmune diseases or having a history of prolonged hormone use or immunosuppressant use within 1 year.
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- Combined with impaired liver function (Child - Pugh C) or renal insufficiency (serum creatinine level over 442μmol•L-1).
- Known hypersensitivity or suspected allergy to intervention drugs.
- Proposed postoperative admission to ICU.
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital affliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200126
About this study
Official title: Influence of General Anesthesia Versus Spinal Anesthesia on Circulating Tumor Cells in Patients Undergoing Transurethral Resection of Bladder Tumor
Multiple lines of evidence have shown that anesthesia method is associated with long-term outcomes in patients undergoing surgery due to cancers, including lung, breast, prostate, and bladder cancer, etc. Circulating tumor cells (CTCs) have been validated as prognostic biomarkers of a number of cancers. The aim of this study is to investigate the effects of anesthesia methods on the number of CTCs in patients receiving transurethral resection of bladder tumor (TURBT). The difference of anesthesia method is achieved by using general anesthesia in one group and spinal anesthesia in the other group.
- Conditions
- Bladder Cancer
- Being tested
- General Anesthesia, Spinal Anesthesia
- Keywords
- Circulating Tumor Cells, General Anesthesia, Spinal Anesthesia, Transurethral Resection of Bladder Tumor
- Medical subject headings
- Urinary Bladder Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General AnesthesiaProcedure or surgery
Patients will have TURBT under general anesthesia, which is induced with midazolam, propofol, sufentanil and rocuronium. The patients will be mechanically ventilated with laryngeal mask airway (LMA). Anesthesia will be maintained with sevoflurane/desflurane, propofol and remifentanil.
Spinal AnesthesiaProcedure or surgery
Patients will have TURBT under spinal anesthesia. 10~15mg of 0.5% ropivacaine will be injected in the subarachnoid cerebrospinal fluid at the levels of L2-L3 or L3-L4 in lumbar space. It will numb the nerve supply of the belly, hips, bottom as well as legs. The patient stays awake and won't feel any pain due to operation.
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia | Active comparator | Patients in this group will receive general anesthesia during TURBT. Receives: Procedure: General Anesthesia |
| Spinal Anesthesia | Experimental | Patients in this group will receive spinal anesthesia during TURBT. Receives: Procedure: Spinal Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of Circulating Tumor Cells
The number of circulating tumor cells will be measured by collecting 5 ml of venous blood sample.
Measured: on the Day 7~10 after surgery
Secondary outcomes (5)
Surgeon Satisfaction
The surgeon satisfaction will be measured with the Likert scale, which ranges from 0 to 50, with a higher score indicating higher satisfaction.
Measured: immediately after surgery
Patient Satisfaction
The patient satisfaction will be measured with the Modified Bauer Scale, which ranges from 0 to 50, with a higher score indicating higher satisfaction.
Measured: within 24 hours after surgery
Visual Analogue Scale
Pain intensity will be assessed using the Visual Analogue Scale, which ranges from 0 to 10, with a higher score indicating greater pain intensity at 24 hours after surgery.
Measured: at 24 hours after surgery
Nausea Score
Nausea score will be assessed using the Numerical Rating Scale, which ranges from 0 to 10, with a higher score indicating greater nausea ou score at 24 hours after surgery.
Measured: at 24 hours after surgery
Hospitalization Days
The length of hospital stay will be recorded.
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start15 Aug 2023 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Tian, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824299
- Sponsor's protocol ID
- CTC20230408
- Status last verified
- Aug 2023
- First submitted
- 9 Apr 2023
- Last updated
- 9 Aug 2023
- 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 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of General Anesthesia Versus Spinal Anesthesia on Circulating Tumor Cells in Patients Undergoing Transurethral Resection of Bladder Tumor
- ClinicalTrials.gov ID
- NCT05824299
- Acronym / sponsor ID
- CTC20230408
- Conditions
- Bladder Cancer
- Keywords
- Circulating Tumor Cells, General Anesthesia, Spinal Anesthesia, Transurethral Resection of Bladder Tumor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 15 Aug 2023 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 21 Apr 2023 (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.
Multiple lines of evidence have shown that anesthesia method is associated with long-term outcomes in patients undergoing surgery due to cancers, including lung, breast, prostate, and bladder cancer, etc. Circulating tumor cells (CTCs) have been validated as prognostic biomarkers of a number of cancers. The aim of this study is to investigate the effects of anesthesia methods on the number of CTCs in patients receiving transurethral resection of bladder tumor (TURBT). The difference of anesthesia method is achieved by using general anesthesia in one group and spinal anesthesia in the other group.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia | Active comparator | Procedure: General AnesthesiaPatients in this group will receive general anesthesia during TURBT. |
| Spinal Anesthesia | Experimental | Procedure: Spinal AnesthesiaPatients in this group will receive spinal anesthesia during TURBT. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- .≤18 Age ≤85，ASAI-III.
- .Patients with primary bladder cancer of Stage T1 to T4, who are scheduled for transurethral resection of bladder tumor.
- .Written informed consent.
Key exclusion criteria (9 listed)
- History of surgery within 6 months.
- Contraindications for spinal anesthesia.
- With a history of any other malignancy.
- Having received preoperative neoadjuvant therapy.
- History of long-term opioid use.
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 |
|---|---|---|
| General AnesthesiaPatients will have TURBT under general anesthesia, which is induced with midazolam, propofol, sufentanil and rocuronium. The patients will be mechanically ventilated with laryngeal mask airway (LMA). Anesthesia will be maintained with sevoflurane/desflurane, propofol and remifentanil. | Procedure or surgery | General Anesthesia |
| Spinal AnesthesiaPatients will have TURBT under spinal anesthesia. 10~15mg of 0.5% ropivacaine will be injected in the subarachnoid cerebrospinal fluid at the levels of L2-L3 or L3-L4 in lumbar space. It will numb the nerve supply of the belly, hips, bottom as well as legs. The patient stays awake and won't feel any pain due to operation. | Procedure or surgery | Spinal Anesthesia |
Primary outcome
the number of Circulating Tumor Cells
Time frame: on the Day 7~10 after surgery
The number of circulating tumor cells will be measured by collecting 5 ml of venous blood sample.
5 secondary outcomes
Surgeon Satisfaction
Time frame: immediately after surgery
Patient Satisfaction
Time frame: within 24 hours after surgery
Visual Analogue Scale
Time frame: at 24 hours after surgery
Nausea Score
Time frame: at 24 hours after surgery
Hospitalization Days
Time frame: up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General Anesthesia and Spinal Anesthesia in people with Bladder Cancer, run by RenJi Hospital at 1 site in China.
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 9 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 9 Aug 2023. 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 China. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of Circulating Tumor Cells (time frame: on the Day 7~10 after surgery). 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 9 Aug 2023.