Influence of Anesthesia Methods on CTCs in TURBT Patients

RenJi Hospital162 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

162

Conditions

Bladder Cancer

Interventions

General AnesthesiaPROCEDURE

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

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

Renji Hospital affliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

the number of Circulating Tumor Cells

The number of circulating tumor cells will be measured by collecting 5 ml of venous blood sample.

Time frame: on the Day 7~10 after surgery

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: at 24 hours after surgery

Hospitalization Days

The length of hospital stay will be recorded.

Time frame: up to 30 days

Data from ClinicalTrials.gov

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