Influence of Anesthesia Methods on CTCs in TURBT Patients

Study Overview
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Brief Summary
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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.

Official Title
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Influence of General Anesthesia Versus Spinal Anesthesia on Circulating Tumor Cells in Patients Undergoing Transurethral Resection of Bladder Tumor

Conditions
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Bladder Cancer

Intervention / Treatment
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* Procedure: General Anesthesia
* Procedure: Spinal Anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: .≤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. Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: General Anesthesia<br>Patients in this group will receive general anesthesia during TURBT. | Procedure: General Anesthesia<br>* 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.<br>|
| Experimental: Spinal Anesthesia<br>Patients in this group will receive spinal anesthesia during TURBT. | Procedure: Spinal Anesthesia<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of Circulating Tumor Cells | The number of circulating tumor cells will be measured by collecting 5 ml of venous blood sample. | on the Day 7 10 after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | at 24 hours after surgery | 
| Hospitalization Days | The length of hospital stay will be recorded. | up to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Circulating Tumor Cells, General Anesthesia, Spinal Anesthesia, Transurethral Resection of Bladder Tumor