An interventional study of General Anesthesia and Spinal Anesthesia in Bladder Cancer, sponsored by RenJi Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-08-09.
Sponsored by RenJi Hospital · Not applicable, Interventional, and Health services research
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.
1,617 studies on the registry are indexed under Urinary Bladder Neoplasms; 422 are open to participants now.
This study's planned enrollment of 162 is above the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.
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Exclusion Criteria:
Patients in this group will receive general anesthesia during TURBT.
Procedure: General Anesthesia
Patients in this group will receive spinal anesthesia during TURBT.
Procedure: Spinal 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.
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.
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
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
Plan to share: No
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This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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RenJi Hospital