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Trial Title:
Influence of Anesthesia Methods on CTCs in TURBT Patients
NCT ID:
NCT05824299
Condition:
Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Anesthetics
Conditions: Keywords:
Circulating Tumor Cells
General Anesthesia
Spinal Anesthesia
Transurethral Resection of Bladder Tumor
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Health Services Research
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
General Anesthesia
Description:
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.
Arm group label:
General Anesthesia
Intervention type:
Procedure
Intervention name:
Spinal Anesthesia
Description:
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.
Arm group label:
Spinal Anesthesia
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Renji Hospital affliated to Shanghai Jiaotong University School of Medicine
Address:
City:
Shanghai
Zip:
200126
Country:
China
Start date:
August 15, 2023
Completion date:
June 30, 2024
Lead sponsor:
Agency:
RenJi Hospital
Agency class:
Other
Source:
RenJi Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05824299
