Influence of Anesthesia Methods on CTCs in TURBT Patients

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05824299
• Other study ID #: CTC20230408
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 15, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2023
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 162
• Est. completion date: June 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Procedure:
• General 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.
• Spinal 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.

Locations

Country	Name	City	State
China	Renji Hospital affliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Hospitalization Days	The length of hospital stay will be recorded.	up to 30 days