Bladder Cancer
Conditions
Keywords
Circulating Tumor Cells, General Anesthesia, Spinal Anesthesia, Transurethral Resection of Bladder Tumor
Brief 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. 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.
Interventions
PROCEDUREGeneral Anesthesia
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.
PROCEDURESpinal Anesthesia
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.
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. .≤18 Age ≤85，ASAI-III. 2. .Patients with primary bladder cancer of Stage T1 to T4, who are scheduled for transurethral resection of bladder tumor. 3. .Written informed consent.
Exclusion criteria
1. History of surgery within 6 months. 2. Contraindications for spinal anesthesia. 3. With a history of any other malignancy. 4. Having received preoperative neoadjuvant therapy. 5. History of long-term opioid use. 6. Combined with autoimmune diseases or having a history of prolonged hormone use or immunosuppressant use within 1 year. 7. Combined with impaired liver function (Child - Pugh C) or renal insufficiency (serum creatinine level over 442μmol•L-1). 8. Known hypersensitivity or suspected allergy to intervention drugs. 9. Proposed postoperative admission to ICU.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the number of Circulating Tumor Cells | on the Day 7~10 after surgery | The number of circulating tumor cells will be measured by collecting 5 ml of venous blood sample. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgeon Satisfaction | immediately after surgery | The surgeon satisfaction will be measured with the Likert scale, which ranges from 0 to 50, with a higher score indicating higher satisfaction. |
| Patient Satisfaction | within 24 hours after surgery | The patient satisfaction will be measured with the Modified Bauer Scale, which ranges from 0 to 50, with a higher score indicating higher satisfaction. |
| Visual Analogue Scale | at 24 hours after surgery | 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. |
| Nausea Score | at 24 hours after surgery | 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. |
| Hospitalization Days | up to 30 days | The length of hospital stay will be recorded. |
Countries
China
Outcome results
None listed